Medical Policy

Policy Num:     08.001.045
Policy Name:   Cranial Electrotherapy Stimulation and Auricular Electrostimulation
Policy ID:         [08.001.045]  [Ac / B / M- / P-]  [8.01.58]

Last Review:    March 12, 2025
Next Review:    March 20, 2026
 

Related Policies:

01.001.020 Transcutaneous Electrical Nerve Stimulation

02.001.033 Transcranial Magnetic Stimulation as a Treatment of Depression and Other Psychiatric/Neurologic Disorders

07.001.118 Percutaneous Electrical Nerve Stimulation or Percutaneous Neuromodulation Therapy

 Cranial Electrotherapy Stimulation and Auricular Electrostimulation

SUMMARY

 Description

Cranial electrotherapy stimulation (CES), also known as cranial electrical stimulation, transcranial electrical stimulation, or electrical stimulation therapy, delivers weak pulses of electrical current to the earlobes, mastoid processes, or scalp with devices such as the Alpha-Stim. Auricular electrostimulation involves the stimulation of acupuncture points on the ear. Devices, including the P-Stim and e-pulse, provide ambulatory auricular electrical stimulation over a period of several days. Cranial electrotherapy stimulation is being evaluated for a variety of conditions, including pain, insomnia, depression, anxiety, and functional constipation. Auricular electrical stimulation is being evaluated for pain, weight loss, and opioid withdrawal.

Summary of Evidence

Cranial Electrotherapy Stimulation

For individuals who have acute or chronic pain who receive cranial electrotherapy stimulation (CES), the evidence includes a number of small sham-controlled randomized trials and pooled analyses. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. Systematic reviews of randomized trials evaluated CES for headache and chronic pain. Pooled analyses found marginal benefits for headache with CES and no benefits for chronic pain with CES. A subsequent sham-controlled trial of remotely supervised CES via secure videoconferencing found a significant benefit with CES for pain reduction, but it had important relevance and conduct and design limitations. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have psychiatric, behavioral, or neurologic conditions (eg, depression and anxiety, Parkinson disease, addiction) who receive CES, the evidence includes a number of small sham-controlled randomized trials and systematic reviews. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. Four randomized controlled trials (RCTs) evaluated CES for depression and anxiety. One RCT each found a significant benefit with CES for anxiety or depression, but both had important relevance limitations. Comparisons between these trials cannot be made due to the heterogeneity in study populations and treatment protocols. Studies evaluating CES for Parkinson disease, smoking cessation, and tic disorders do not support the use of CES for these conditions. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have functional constipation who receive CES, the evidence includes an RCT. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. The single RCT reported positive results for the treatment of constipation with CES. However, the trial was unblinded and most outcomes were self-reported. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Auricular Electrostimulation

For individuals who have acute or chronic pain (eg, acute pain from surgical procedures, chronic back pain, chronic pain from osteoarthritis or rheumatoid arthritis) who receive auricular electrostimulation, the evidence includes a limited number of trials. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. Studies evaluating the effect of electrostimulation technology on acute pain are inconsistent, and the small amount of evidence on chronic pain has methodologic limitations. For example, a comparison of auricular electrostimulation with manual acupuncture for chronic low back pain did not include a sham control group, and, in a study of rheumatoid arthritis, auricular electrostimulation was compared with autogenic training and resulted in a small improvement in visual analog scale pain scores of unclear clinical significance. Overall, the few published studies have small sample sizes and methodologic limitations. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have obesity who receive auricular electrostimulation, the evidence includes small RCTs and systematic reviews. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. The RCTs reported inconsistent results and used different treatment protocols. The systematic reviews are limited by high heterogeneity with respect to the interventions used, participants included, treatment period, and outcome measures. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have opioid withdrawal symptoms who receive auricular electrostimulation, the evidence includes 2 observational studies. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. Both studies report positive outcomes for the use of CES to treat opioid withdrawal symptoms. The studies used different treatment protocols and no comparators, limiting conclusions drawn from the results. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Additional Information

Not applicable.

OBJECTIVE

 The objective of this evidence review is to evaluate whether cranial electrostimulation therapy or electrical stimulation of auricular acupuncture points improves the net health outcome in patients with chronic pain, psychiatric, behavioral, or neurological conditions, functional constipation, obesity, or opioid withdrawal.

POLICY STATEMENTS

 Cranial electrotherapy stimulation (also known as cranial electrostimulation therapy) is investigational in all situations.

Electrical stimulation of auricular acupuncture points is investigational in all situations.

POLICY GUIDELINES

Coding

See the Codes table for details.

BENEFIT APPLICATION

BlueCard/National Account Issues

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

BACKGROUND

Cranial electrotherapy stimulation (CES), also known as cranial electrical stimulation, transcranial electrical stimulation, or electrical stimulation therapy, delivers weak pulses of electrical current to the earlobes, mastoid processes, or scalp with devices such as the Alpha-Stim. Auricular electrostimulation involves the stimulation of acupuncture points on the ear. Devices, including the P-Stim and e-pulse, provide ambulatory auricular electrical stimulation over a period of several days. Cranial electrotherapy stimulation and auricular electrostimulation are being evaluated for a variety of conditions, including pain, insomnia, depression, anxiety, weight loss, and opioid withdrawal.

Interest in CES began in the early 1900s on the theory that weak pulses of electrical current have a calming effect on the central nervous system. The technique was further developed in the U.S.S.R. and Eastern Europe in the 1950s as a treatment for anxiety and depression and use of CES later spread to Western Europe and the United States as a treatment for various psychological and physiological conditions. Presently, the mechanism of action is thought to be the modulation of activity in brain networks by direct action in the hypothalamus, limbic system, and/or the reticular activating system. One device used in the United States is the Alpha-Stim CES, which provides pulsed, low-intensity current via clip electrodes that attach to the earlobes. Other devices place the electrodes on the eyelids, frontal scalp, mastoid processes, or behind the ears. Treatments may be administered once or twice daily for several days to several weeks.

Other devices provide electrical stimulation to auricular acupuncture sites over several days. One device, the P-Stim, is a single-use miniature electrical stimulator for auricular acupuncture points that is worn behind the ear with a self-adhesive electrode patch. A selection stylus that measures electrical resistance is used to identify 3 auricular acupuncture points. The P-Stim device connects to 3 inserted acupuncture needles with caps and wires. The device is preprogrammed to be on for 180 minutes, then off for 180 minutes. The maximum battery life of this single-use device is 96 hours.

Regulatory Status

A number of devices for CES have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. In 1992, the Alpha-Stim CES device (Electromedical Products International) received marketing clearance for the treatment of anxiety, insomnia, and depression. Devices cleared since 2000 are summarized in Table 1.

FDA product code: QJQ.

Table 1. Cranial Electrotherapy Stimulation Devices Cleared by the U.S. Food and Drug Administration

Several devices for electroacupuncture designed to stimulate auricular acupuncture points have been cleared for marketing by the FDA through the 510(k) process. Devices cleared since 2000 are summarized in Table 2.

FDA product codes: BWK, PZR.

Table 2. Auricular Electrostimulation Devices Cleared by the U.S. Food and Drug Administration

  a "FDA cleared the NSS-2 Bridge Device for Substance Use Disorders through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence"1, N/A: Not applicable

RATIONALE

This evidence review was created in September 2011 with searches of the PubMed database. The most recent literature update was performed through January 7, 2025.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Population Reference No. 1

Cranial Electrotherapy Stimulation for Acute or Chronic Pain

Clinical Context and Therapy Purpose

The purpose of cranial electrotherapy stimulation (CES) is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as medical management and other conservative therapies, in individuals with acute or chronic pain.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with acute or chronic pain.

Interventions

The therapy being considered is CES.

Comparators

Comparators of interest include medical management and other conservative therapies. Treatments include physical exercise, stress management, and analgesic and narcotic medication therapy.

Outcomes

The general outcomes of interest are symptoms, morbid events, functional outcomes, and treatment-related morbidity. While studies described below have varying lengths of follow-up, longer follow-up is necessary to fully observe outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess longer-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Headache

Klawansky et al (1995) published a meta-analysis of 14 RCTs comparing CES with sham for the treatment of various psychological and physiological conditions.^2, The literature search, conducted through 1991, identified 2 trials evaluating CES for the treatment of headache. Pooled analysis of the 2 trials (N=102 patients) favored CES over placebo (0.68; 95% confidence interval [CI], 0.09 to 1.28).

A Cochrane review by Bronfort et al (2004) assessed noninvasive treatments for headaches; reviewers conducted a literature search through November 2002.^3, They identified 1 poor quality, placebo-controlled, randomized trial (N=100) of CES for a migraine or a tension-type headache. Results from the trial showed greater reductions in pain intensity in the CES group than in the placebo group (effect size, 0.4; 95% CI, 0.0 to 0.8). A 2014 update to this review has been withdrawn due to the desire to replace the review with 3 separate reviews; however, these were unable to be completed.^4,

Chronic Pain

A Cochrane review by O’Connell et al (2014) evaluated noninvasive brain stimulation techniques for chronic pain and conducted a literature search through July 2013.^5, Reviewers identified 11 randomized trials of CES for chronic pain. A meta-analysis of 5 trials (N=270 participants) found no significant difference in pain scores between active and sham stimulation (standard mean difference [SMD], -0.24; 95% CI, -0.48 to 0.01) for the treatment of chronic pain. A 2018 update did not find additional trials for CES.^6,

Subsequent to the Cochrane review by O’Connell et al (2018),^6, Ahn et al (2020) published a double-blind, randomized, sham-controlled pilot study of the feasibility and efficacy of remotely supervised CES via secure videoconferencing in 30 older adults with chronic pain due to knee osteoarthritis.^7, Mean age was 59.43 years. Cranial electrotherapy stimulation was delivered via the Alpha-Stim M Stimulator, which was preset at 0.1 mA at a frequency of 0.5 Hz, and applied for 1 hour daily on weekdays for 2 weeks. The sham electrodes were identical in appearance and placement, but the stimulator did not deliver electrical current. The study was conducted in a single center in Houston. All 30 participants completed the study and were included in the outcome analyses. For the primary outcome of clinical pain at 2 weeks as assessed by a Numeric Rating Scale, a significantly greater reduction occurred in the active CES group (-17.00 vs. +5.73; p<.01). No patients reported any adverse effects. Important relevancy limitations include lack of assessment of important health outcomes or long-term efficacy. An important conduct and design limitation is that it is unclear how convincing the sham procedure was as it did not involve any feature designed to simulate a tingling sensation and give the patient the feeling of being treated (ie, subtherapeutic amplitude, initial current slowly turned to zero). Thus, findings may be subject to the placebo effect. This trial was also limited by the small number of participants. These limitations preclude drawing conclusions based on these findings.

Section Summary: Acute or Chronic Pain

Systematic reviews of randomized trials were identified testing CES for the treatment of headache, with analyses marginally favoring CES over placebo. A meta-analysis of 5 trials comparing CES with sham for the treatment of chronic pain found no difference between the treatment and sham groups. A sham-controlled trial of remotely supervised CES via secure videoconferencing found a significant benefit with CES for pain reduction, but it had important relevance and design and conduct limitations. Additional evidence is needed to permit conclusions about whether CES improves outcomes for individuals with chronic pain.

For individuals who have acute or chronic pain who receive cranial electrotherapy stimulation (CES) , the evidence includes a number of small sham-controlled randomized trials and pooled analyses. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. Systematic reviews of randomized trials evaluated CES for headache and chronic pain. Pooled analyses found marginal benefits for headache with CES and no benefits for chronic pain with CES. A subsequent sham-controlled trial of remotely supervised CES via secure videoconferencing found a significant benefit with CES for pain reduction, but it had important relevance and conduct and design limitations. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 2

Cranial Electrotherapy Stimulation for Psychiatric, Behavioral, or Neurologic Conditions

Clinical Context and Therapy Purpose

The purpose of CES is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as standard therapy, in individuals with psychiatric, behavioral, or neurologic conditions.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with psychiatric, behavioral, or neurologic conditions.

Interventions

The therapy being considered is CES.

Comparators

Comparators of interest include standard therapy. Treatment includes psychiatric counseling.

Outcomes

The general outcomes of interest are symptoms, morbid events, functional outcomes, and treatment-related morbidity. While studies described below have varying lengths of follow-up, longer follow-up is necessary to fully observe outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess longer-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Anxiety and Depression

Systematic Reviews

An older meta-analysis by Klawansky et al (1995) described in the Headache section above, analyzed 8 trials (N=228 patients) comparing CES with sham for the treatment of anxiety.^2, While only 2 studies independently reported CES to be more effective than sham, the pooled estimate found CES to be significantly more effective than sham (-0.59; 95% CI, -0.95 to -0.23). More recently, Price et al (2021) published a meta-analysis evaluating CES for the treatment of depression and/or anxiety and depression (Tables 3, 4, and 5).^8, Five RCTs and 12 open-label, non-randomized studies that utilized Alpha-Stim were included. When considering pooled data from RCTs, results demonstrated that the mean depression level at posttest for the CES group was -0.69 standard deviations lower than the mean depression level for the sham stimulation group, which corresponds to a medium effect size. Pooled data from nonrandomized studies showed a smaller effect of -0.43 standard deviations in favor of CES. A 2022 meta-analysis identified 11 RCTs evaluating CES in patients with anxiety (N=794).^9, Anxiety symptoms were significantly reduced with CES versus control (Hedges' g, -0.625; 95% CI, -0.952 to -0.298; p<.001; I²=78.6%). Depressive symptoms were also reduced in these patients (Hedges' g, -0.648; 95% CI, -1.062 to -0.234; p=.002; I²=80.31%). The analysis is limited by high variability in the number of sessions (14 to 126), session duration (10 to 60 minutes), outcomes scale, and the small number of patients in each trial.

Table 3. Comparison of Trials/Studies Included in Systematic Reviews and Meta-analyses

Table 4. Systematic Reviews and Meta-analyses Characteristics

Table 5. Systematic Reviews and Meta-analyses Results

Randomized Controlled Trials

The Alpha-Stim Anxiety Insomnia and Depression (AID) device was evaluated in the multicenter, double-blind Alpha-Stim-D RCT.^10,11, Patients with moderate to severe major depression received 8 weeks of once daily treatment with Alpha-Stim AID or a sham device. Patients without recent/prior antidepressant use were eligible, although only about 15% of patients had not used antidepressants in the prior 3 months. At week 16, the primary endpoint (the 17-item Hamilton Depression Rating Scale) had decreased by a mean of 5.9 points with Alpha-Stim AID and 6.5 points with the sham device (difference, -0.6; 95% CI, -1.0 to 2.2; p=.46). The decreases in both groups were clinically important, but the difference between groups was not significant. Adverse events and tolerability were similar between groups. It is unclear whether patients in the sham device group were allowed to use concurrent antidepressants or behavioral therapy.

Kim et al (2021) reported on a 3-week randomized, double-blind, sham-controlled trial evaluating the effectiveness of home-based CES (n=25) versus sham treatment (n=29) in nonclinical patients with daily anxiety.^12, Novel, headphone-like, in-ear electrodes were used in this study. Results demonstrated a significant reduction in anxiety scores using the State Anxiety Inventory (SAI) with CES versus sham stimulation treatment. Depression inventory scores did not significantly differ between groups. Limitations of this study included the use of a small sample of nonclinical patients, short follow-up, post-randomization withdrawals that did not contribute data to the analysis, and the unclear clinical significance of a decreased anxiety inventory score.

Barclay and Barclay (2014) reported on a randomized, double-blind, sham-controlled trial evaluating the effectiveness of 1 hour of daily CES for patients with anxiety (n=115) and comorbid depression (n=23) (Table 6).^13, Analysis of covariance showed a significant advantage of active CES over sham for both anxiety (p=.001) and depression (p=.001) over 5 weeks of treatment (Table 7). The mean decrease in the Hamilton Rating Scale for Anxiety score was 32.8% for active CES and 9.1% for sham. The mean decrease in the Hamilton Rating Scale for Depression score was 32.9% for active CES and 2.6% for sham. However, because key health outcomes were not addressed and, as noted in a Veterans Affairs Evidence Synthesis Program review in 2018 by Shekelle et al,^14, due to the serious methodological limitations of this study (ie, unclear sham credibility), the strength of this evidence is low.

In a smaller, double-blind, sham-controlled randomized trial (N=30), Mischoulon et al (2015) found no significant benefit of CES as adjunctive therapy in patients with treatment-resistant major depression (Tables 6 and 7).^15, Both active and sham groups showed improvements in depression over the 3 weeks of the study, suggesting a strong placebo effect.

In 2015, a sham-controlled, double-blind randomized trial by Lyon et al found no significant benefit of CES with the Alpha-Stim device for symptoms of depression, anxiety, pain, fatigue, and sleep disturbances in women receiving chemotherapy for breast cancer (Tables 6 and 7).^16, This phase 3 trial randomized 167 women with early-stage breast cancer to 1 hour of daily CES or to sham stimulation beginning within 48 hours of the first chemotherapy session and continuing until 2 weeks after chemotherapy ended (range, 6 to 32 weeks). Stimulation intensity was below the level of sensation. Active and sham devices were factory preset, and neither evaluators nor patients were aware of the treatment assignment. Outcomes were measured using validated questionnaires that assessed pain, anxiety, and depression, fatigue, and sleep disturbance. There were no significant differences between the active and sham CES groups during treatment. However, the trial might have been limited by low symptoms levels at baseline, resulting in a floor effect, and the low level of stimulation.

Gehrman et al (2024) published the results of a triple-blind RCT that compared an investigational CES device (OAK, Fischer Wallace Labs) to sham treatment in 255 patients with major depressive disorder.^17, At baseline, patients had to have a Beck Depression Inventory (second edition) score between 20 and 63. Each group received treatment for 2 sessions daily (20 minutes each) for 4 weeks. In the intention to treat population, Beck Depression Inventory scores did not improve between baseline and week 2 (the primary endpoint). However, this outcome was significantly improved when only patients with high adherence were considered (p=.005). Beck Depression Inventory scores were significantly improved at weeks 1 (p=.02) and 4 (p=.028). No major safety concerns were reported. A similar study with the same device in patients with anxiety is awaiting publication.

Table 6. Summary of Randomized Controlled Trial Characteristics Assessing Cranial Electrotherapy Stimulation for Anxiety and Depression

Table 7. Summary of Randomized Controlled Trial Results Assessing Cranial Electrotherapy Stimulation for Anxiety and Depression

Tables 8 and 9 summarize the important relevance and design and conduct limitations of the RCTs discussed above.

Table 8. Study Relevance Limitations

Table 9. Study Design and Conduct Limitations

Parkinson Disease

Shill et al (2011) found no benefit of CES with the Nexalin device for motor or psychological symptoms in a crossover study of 23 patients with early Parkinson disease.^18,

Smoking Cessation

Pickworth et al (1997) reported that 5 days of CES was ineffective for reducing withdrawal symptoms or facilitating smoking cessation in a double-blind RCT of 101 cigarette smokers who wanted to stop smoking.^19,

Tic Disorders

Wu et al (2020) published a double-blind, randomized, sham-controlled trial of the efficacy and safety of CES as an add-on treatment for tic disorders in 62 children and adolescents who lacked a clinical response to prior treatment of 4 weeks of pharmacotherapy.^20, Cranial electrotherapy stimulation was delivered via the CES Ultra stimulator (American Neuro Fitness LLC) at 500 μA-mA and applied for 30 minutes daily on weekdays for 40 days. The sham CES was delivered at lower than 100 μA. The study was conducted at a single academic medical center in China. A total of 9 participants (14.5%) discontinued the intervention early and were excluded from the analyses. There was no significant difference between the active CES and sham groups in the change in Yale Global Tic Severity Scale (YGTSS) score (-31.66% vs. 23.96%; p=.13).

Section Summary: Psychiatric, Behavioral, or Neurologic Conditions

The most direct evidence related to CES for anxiety and depression comes from 5 sham-controlled randomized trials and systematic reviews. One RCT each found a significant benefit with CES for anxiety or depression, but both had important relevance limitations. Additional evidence is needed to permit conclusions about whether CES improves outcomes for individuals with anxiety or depression. The evidence for depression, anxiety, Parkinson disease, smoking cessation, and tic disorders does not support the use of CES.

For individuals who have psychiatric, behavioral, or neurologic conditions (eg, depression and anxiety, Parkinson disease, addiction) who receive CES, the evidence includes a number of small sham-controlled randomized trials and systematic reviews. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. Four randomized controlled trials (RCTs) evaluated CES for depression and anxiety. One RCT each found a significant benefit with CES for anxiety or depression, but both had important relevance limitations. Comparisons between these trials cannot be made due to the heterogeneity in study populations and treatment protocols. Studies evaluating CES for Parkinson disease, smoking cessation, and tic disorders do not support the use of CES for these conditions. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 3

Cranial Electrotherapy Stimulation for Functional Constipation

Clinical Context and Therapy Purpose

The purpose of CES is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as medication, biofeedback, and behavior modification in individuals with functional constipation.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with functional constipation.

Interventions

The therapy being considered is CES.

Comparators

Comparators of interest include medication, biofeedback, and behavior modification. Treatment includes dietary modifications and a maintenance regimen of laxatives.

Outcomes

The general outcomes of interest are symptoms, morbid events, functional outcomes, and treatment-related morbidity. While studies described below have varying lengths of follow-up, longer follow-up is necessary to fully observe outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess longer-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Gong et al (2016) reported on a single-center, unblinded RCT comparing CES (Alpha-Stim) with biofeedback in 74 subjects with functional constipation.^21, Eligible patients met Rome III criteria for functional constipation and had been recommended by their physicians for biofeedback therapy. Patients were randomized to biofeedback with CES (n=38) or biofeedback alone (n=36) and followed at 4 time points (baseline and 3 follow-up visits); however, the duration of time between each follow-up visit was not specified. In a repeated-measures analysis of variance model for change from baseline, at the second and third follow-up visits, there were significant differences between groups in: Self-Rating Anxiety Scale score (41.8 for CES patients vs. 46.8 for controls; p<.001); Self-Rating Depression Scale score (43.08 for CES patients vs. 48.8 for controls; p<.001) and the Wexner Constipation Score (10.0 for CES patients vs. 12.6 for controls; p<.001). A subset of patients underwent anorectal manometry, with no between-group differences in pressure before or after treatment.

Section Summary: Functional Constipation

One RCT was identified evaluating CES for functional constipation. Although this trial demonstrated improvements in several self-reported outcomes, given its unblinded design, there was a high risk of bias. Additional confirmation with stronger studies is needed.

For individuals who have functional constipation who receive CES, the evidence includes an RCT. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. The single RCT reported positive results for the treatment of constipation with CES. However, the trial was unblinded and most outcomes were self-reported. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 4

Auricular Electrostimulation for Acute or Chronic Pain

Clinical Context and Therapy Purpose

The purpose of auricular electrostimulation is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as medical management and other conservative therapies, in individuals with acute or chronic pain.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with acute or chronic pain.

Interventions

The therapy being considered is auricular electrostimulation.

Comparators

Comparators of interest include medical management and other conservative therapies. Treatments include physical exercise, stress management, and analgesic and narcotic medication therapy.

Outcomes

The general outcomes of interest are symptoms, morbid events, functional outcomes, and treatment-related morbidity. While studies described below have varying lengths of follow-up, longer follow-up is necessary to fully observe outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess longer-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Acute Pain

In a 2007 review, Sator-Katzenschlager and Michalek-Sauberer found inconsistent results from studies assessing P-Stim use for the treatment of acute pain (eg, oocyte aspiration, molar tooth extraction).^22,

An RCT by Holzer et al (2011) tested the efficacy of the P-Stim on 40 women undergoing gynecologic surgery.^23, Patients were randomized to auricular acupuncture or sham stimulation. Patients in the control group received electrodes without needles, and the P-Stim devices were applied without electrical stimulation. The P-Stim device was placed behind the ear at the end of surgery on all patients while they were still under general anesthesia, and the dominant ear was completely covered with identical dressing in both groups to maintain blinding. Postoperatively, patients received paracetamol 1000 mg every 6 hours, with additional piritramide (a parenteral opioid) given on demand. Needles and devices were removed 72 hours postoperatively. A blinded observer found no significant difference between the 2 groups in consumption of piritramide during the first 72 hours postoperatively (acupuncture, 15.3 mg vs. placebo, 13.9 mg) or in visual analog scale (VAS) scores taken at 0, 2, 24, 48, and 72 hours (average VAS score: acupuncture, 2.32 vs. placebo, 2.62).

Ilfeld et al (2024) conducted a double-blind RCT pilot study with the NSS-2 Bridge device in 30 patients undergoing cholecystectomy and hernia repair.^24, Treatment with the NSS-2 Bridge or sham stimulation was started in the recovery room and continued for 5 days. Median oxycodone consumption over the first 5 postoperative days was 0 mg in both groups (p=.524). Mean pain intensity over the first 5 postoperative days was 0.6 versus 2.6, respectively (p=.041), on an 11-point numeric rating scale. Adverse events included device discontinuation due to electrode site discomfort (n=3) and electrode placement problems (n=3).

Ilfeld et al (2025) conducted a double-blind RCT pilot study with the NSS-2 Bridge device in 30 patients undergoing primary, unilateral, total knee arthroplasty.^25, Treatment with the NSS-2 Bridge or sham stimulation was started in the recovery room and continued for 5 days. Median oxycodone consumption over the first 5 postoperative days was 4 mg with auricular nerve stimulation versus 13 mg with sham stimulation (p=.039). Mean pain intensity over the first 5 postoperative days was 2.5 versus 4.0, respectively (p=.014), on an 11-point numeric rating scale. No adverse events were reported.

Chronic Low Back Pain

Sator-Katzenschlager et al (2004) reported on a double-blind RCT that compared auricular electroacupuncture with conventional auricular acupuncture in 61 patients with chronic low back pain (at least 6 months).^26, All needles were connected to the P-Stim device. In the control group, devices were applied without electrical stimulation. Treatment was performed once weekly for 6 weeks, with needles withdrawn 48 hours after insertion. Patients received questionnaires assessing pain intensity and quality, psychological well-being, activity level, and quality of sleep usfing VAS. There was a significant reduction in pain at up to the 18-week follow-up. Auricular electroacupuncture resulted in greater improvements in the outcome measures than the control procedure. For example, VAS pain intensity was less than 5 in the control group and less than 2 in the electroacupuncture group. This trial was limited by the small number of participants.

Chronic Cervical Pain

Sator-Katzenschlager et al (2003) presented results from a small, double-blind, randomized trial of 21 patients with chronic cervical pain.^27, In 10 patients, needles were stimulated with a P-Stim device, and in 11 patients, no stimulation was administered. Treatment was administered once a week for 6 weeks. Patients receiving electrical stimulation experienced significant reductions in pain scores and improvements in psychological well-being, activity, and sleep.

Rheumatoid Arthritis

Bernateck et al (2008) reported on P-Stim use in an RCT of 44 patients with rheumatoid arthritis.^28, The control group received autogenic training, a psychological intervention in which participants learned to relax their limbs, breathing, and heart rate. Electroacupuncture (continuous stimulation for 48 hours at home) and lessons in autogenic training were performed once weekly for 6 weeks. Also, the control patients were encouraged to use an audiotape to practice autogenic training every day. The needles and devices were removed after 48 hours. Seven patients withdrew from the study before beginning the intervention; the 37 remaining patients completed the trial through the 3-month follow-up. The primary outcome measures were the mean weekly pain intensity and the Disease Activity Score. At the end of treatment and 3-month follow-up, statistically significant improvements were observed in all outcome measures for both groups. There was greater improvement in the electroacupuncture group (VAS pain score, 2.79) than in the control group (VAS pain score, 3.95) during treatment. This level of improvement did not persist at the 3-month follow-up. The clinical significance of a 1-point difference in VAS score from this small trial is unclear.

Section Summary: Acute or Chronic Pain

One trial of P-Stim for women undergoing gynecologic surgery found no significant reductions in pain outcomes. Trials in chronic low back pain, chronic cervical pain, and rheumatoid arthritis showed small improvements but had methodologic limitations (eg, small sample sizes, large loss to follow-up). Additional studies are needed to determine whether auricular electrostimulation improves outcomes for acute or chronic pain.

For individuals who have acute or chronic pain (eg, acute pain from surgical procedures, chronic back pain, chronic pain from osteoarthritis or rheumatoid arthritis) who receive auricular electrostimulation, the evidence includes a limited number of trials. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. Studies evaluating the effect of electrostimulation technology on acute pain are inconsistent, and the small amount of evidence on chronic pain has methodologic limitations. For example, a comparison of auricular electrostimulation with manual acupuncture for chronic low back pain did not include a sham control group, and, in a study of rheumatoid arthritis, auricular electrostimulation was compared with autogenic training and resulted in a small improvement in visual analog scale pain scores of unclear clinical significance. Overall, the few published studies have small sample sizes and methodologic limitations. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 5

Auricular Electrostimulation for Obesity

Clinical Context and Therapy Purpose

The purpose of auricular electrostimulation is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as standard therapy, in individuals with obesity.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with obesity.

Interventions

The therapy being considered is auricular electrostimulation.

Comparators

Comparators of interest include standard therapy. Treatments include physical exercise, low-carbohydrate dieting, and low-fat dieting.

Outcomes

The general outcomes of interest are symptoms, morbid events, functional outcomes, and treatment-related morbidity. While studies described below have varying lengths of follow-up, longer follow-up is necessary to fully observe outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess longer-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Systematic Reviews

The results of a systematic review and meta-analysis were published by Kim et al (2018).^29, The purpose of this review was to evaluate the effect of acupuncture and other intervention types on weight loss. In total, 27 RCTs were deemed to meet inclusion criteria. These RCTs had 32 intervention arms and 2219 patients. The meta-analysis results indicate that acupuncture plus lifestyle modification was more effective than lifestyle modification alone (Hedges’ g, 1.104; 95% CI, 0.531 to 1.678) and sham acupuncture plus lifestyle modification (Hedges’ g, 0.324; 95% CI, 0.177 to 0.471), whereas acupuncture alone was not more effective than sham acupuncture alone and no treatment. Interestingly, acupuncture treatment was effective only in subjects who were overweight (body mass index 25 to <30 kg/m², Hedges’ g; 0.528; 95% CI, 0.279 to 0.776), not in subjects with obesity (body mass index ≥30 kg/m²). Auricular acupuncture (Hedges’ g, 0.522; 95% CI, 0.152 to 0.893), manual acupuncture, (Hedges’ g, 0445; 95% CI, 0.044 to 0.846) and pharmacopuncture (Hedges’ g, 0.411; 95% CI, 0.026 to 0.796) also were aligned with weight loss. The authors noted significant heterogeneity across studies with respect to the interventions used, participants, and treatment period.

A systematic review was published by Yeh et al (2017), which included the RCTs by Schukro et al (2014) and Yeh et al (2015) that are summarized in the section below.^30, Although their meta-analysis of 13 RCTs with a total of 1775 participants found that auricular acupoint stimulation improves physical anthropometric parameters, including body weight (mean difference, -1.21 kg; 95% CI, -1.94 to -0.47; I²=88%), body mass index (mean difference, -0.57 kg/m²; 95% CI, -0.82 to -0.33; I²=78%), body fat (mean difference, -0.83%; 95% CI, -1.43 to -0.24; I²=0%), and waist circumference (mean difference, -1.75 cm; 95% CI, -2.95 to -0.55; I²=87%) in overweight and obese adults, key limitations of these findings include high heterogeneity for most of the measures and unclear clinical importance of the differences. Although subgroup analyses based on treatment length (shorter [<6 weeks] vs. longer [≥6 weeks]) improved consistency of findings somewhat for the longer subgroup, heterogeneity was still moderate (eg, I²=59% for body weight; I²=52% for body mass index).

Randomized Controlled Trials

Schukro et al (2014) reported on a double-blind RCT evaluating the effects of the P-Stim on weight loss in 56 patients with obesity.^31, The auricular acupuncture points for hunger, stomach, and colon were stimulated 4 days a week over 6 weeks with the P-Stim in the active group (n=28), and the placebo group received treatment with a sham P-Stim device (n=28). At the end of treatment, body weight was reduced by 3.7% in the active stimulation group and 0.7% in the sham group (p<.001). Four weeks after treatment, body weight was reduced by 5.1% in the active stimulation group and 0.2% in the sham group (p<.001). Similar improvements were observed for body mass index and body fat.

Yeh et al (2015) randomized 70 patients to electrical stimulation on true acupressure points or sham acupressure points.^32, As part of the 10-week treatment program, all patients received auricular acupressure and nutrition counseling following the electrical stimulation sessions. Both groups experienced significant improvements in body mass index, blood pressure, and cholesterol levels from baseline. However, there was no significant difference between groups.

Section Summary: Obesity

Randomized controlled trials and systematic reviews that have assessed the use of auricular electrostimulation to treat obesity have had small sample sizes, evaluated different treatment protocols, and have reported inconsistent results.

For individuals who have obesity who receive auricular electrostimulation, the evidence includes small RCTs and systematic reviews. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. The RCTs reported inconsistent results and used different treatment protocols. The systematic reviews are limited by high heterogeneity with respect to the interventions used, participants included, treatment period, and outcome measures. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 6

Auricular Electrostimulation for Opioid Withdrawal Symptoms

Clinical Context and Therapy Purpose

The purpose of auricular electrostimulation is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as standard therapy in individuals with opioid withdrawal symptoms.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with opioid withdrawal symptoms.

Interventions

The therapy being considered is auricular electrostimulation.

Comparators

Comparators of interest include standard therapy. Treatment includes opioid analgesics.

Outcomes

The general outcomes of interest are symptoms, morbid events, functional outcomes, and treatment-related morbidity. While studies described below have varying lengths of follow-up, longer follow-up is necessary to fully observe outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess longer-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Observational Studies

Kroening and Oleson (1985) published a case series assessing 14 patients with chronic pain who were scheduled for withdrawal from their opiate medications.^33, During the withdrawal process, patients were given oral methadone, followed by bilateral auricular electroacupuncture for 2 to 6 hours, and periodic intravenous injections of low dose naloxone. On successive days, the methadone doses were halved. By day 7, 12 of 14 patients were completely withdrawn from methadone. Through at least 1-year follow-up, the 12 patients experienced minimal or no withdrawal symptoms and remained off narcotic medications.

Miranda and Taca (2018) conducted an open-label, uncontrolled, retrospective pilot study to evaluate the effect of neuromodulation with percutaneous electrical field stimulation on opioid withdrawal symptoms.^34, Eight participating clinics provided data on 73 patients who met Diagnostic and Statistical Manual of Mental Health Disorders, 4th edition, criteria for opioid dependence and voluntarily agreed to be treated with the NSS-2 Bridge device. All providers were trained to use the device through online modules. Patients were monitored during the first hour following implantation of the device and sent home with instructions to return for follow-up within 1 to 5 days, depending on the clinic, and to keep the device on for the entire 5-day period. The primary outcome of withdrawal symptom improvement was measured using the Clinical Opioid Withdrawal Scale (COWS), which ranges from 0 to 48 (5 to 12=mild, 13 to 24=moderate, 25 to 36=moderately severe, >36=severe). Another outcome was a successful transition, defined as receiving first maintenance medication on day 5 of the study. The mean baseline COWS score was 20.1. At 20 minutes, the mean COWS score decreased to 7.5; at 30 minutes, the mean COWS score was 4.0; and at 60 minutes, the mean COWS score was 3.1. At a 5-day follow-up, 89% of patients successfully transitioned to maintenance medication.

Section Summary: Opioid Withdrawal Symptoms

Evidence on the use of auricular electrostimulation to treat patients with opioid withdrawal symptoms consists of 2 observational studies with different protocols. Both studies reported successful alleviation of opioid withdrawal symptoms, though, without comparators, conclusions that can be drawn from this evidence are limited.

For individuals who have opioid withdrawal symptoms who receive auricular electrostimulation, the evidence includes 2 observational studies. Relevant outcomes are symptoms, morbid events, functional outcomes, and treatment-related morbidity. Both studies report positive outcomes for the use of CES to treat opioid withdrawal symptoms. The studies used different treatment protocols and no comparators, limiting conclusions drawn from the results. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

SUPPLEMENTAL INFORMATION

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Clinical Input From Physician Specialty Societies and Academic Medical Centers

While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

2011 Input

In response to requests, input on auricular electrostimulation was received from 3 physician specialty societies and 5 academic medical centers while this policy was under review in 2011. There was a consensus that auricular electrostimulation is investigational.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

No guidelines or statements were identified.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Medicare National Coverage

There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.

Ongoing and Unpublished Clinical Trials

Table 10 provides a summary of ongoing and unpublished trials that may influence this review.

Table 10. Summary of Key Trials

REFERENCES

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7. Ahn H, Galle K, Mathis KB, et al. Feasibility and efficacy of remotely supervised cranial electrical stimulation for pain in older adults with knee osteoarthritis: A randomized controlled pilot study. J Clin Neurosci. Jul 2020; 77: 128-133. PMID 32402609
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10. Patel S, Boutry C, Patel P, et al. A randomised controlled trial investigating the clinical and cost-effectiveness of Alpha-Stim AID cranial electrotherapy stimulation (CES) in patients seeking treatment for moderate severity depression in primary care (Alpha-Stim-D Trial). Trials. Apr 04 2022; 23(1): 250. PMID 35379314
11. Morriss R, Patel S, Boutry C, et al. Clinical effectiveness of active Alpha-Stim AID versus sham Alpha-Stim AID in major depression in primary care in England (Alpha-Stim-D): a multicentre, parallel group, double-blind, randomised controlled trial. Lancet Psychiatry. Mar 2023; 10(3): 172-183. PMID 36724796
12. Kim J, Kim H, Kim DH, et al. Effects of cranial electrotherapy stimulation with novel in-ear electrodes on anxiety and resting-state brain activity: A randomized double-blind placebo-controlled trial. J Affect Disord. Dec 01 2021; 295: 856-864. PMID 34706456
13. Barclay TH, Barclay RD. A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression. J Affect Disord. Aug 2014; 164: 171-7. PMID 24856571
14. Shekelle PG, Cook IA, Miake-Lye IM, et al. Benefits and Harms of Cranial Electrical Stimulation for Chronic Painful Conditions, Depression, Anxiety, and Insomnia: A Systematic Review. Ann Intern Med. Mar 20 2018; 168(6): 414-421. PMID 29435567
15. Mischoulon D, De Jong MF, Vitolo OV, et al. Efficacy and safety of a form of cranial electrical stimulation (CES) as an add-on intervention for treatment-resistant major depressive disorder: A three week double blind pilot study. J Psychiatr Res. Nov 2015; 70: 98-105. PMID 26424428
16. Lyon D, Kelly D, Walter J, et al. Randomized sham controlled trial of cranial microcurrent stimulation for symptoms of depression, anxiety, pain, fatigue and sleep disturbances in women receiving chemotherapy for early-stage breast cancer. Springerplus. 2015; 4: 369. PMID 26435889
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18. Shill HA, Obradov S, Katsnelson Y, et al. A randomized, double-blind trial of transcranial electrostimulation in early Parkinson's disease. Mov Disord. Jul 2011; 26(8): 1477-80. PMID 21538515
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24. Ilfeld BM, Abramson WB, Alexander B, et al. Percutaneous auricular neuromodulation (nerve stimulation) for the treatment of pain following cholecystectomy and hernia repair: a randomized, double-masked, sham-controlled pilot study. Reg Anesth Pain Med. Sep 02 2024; 49(9): 628-634. PMID 38388014
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CODES

POLICY HISTORY

PAYMENT POLICY GUIDELINES

ADMINISTRATIVE EVALUATION

Considered investigational.

ECONOMIC IMPACT

INTERQUAL CRITERIA

POLICY CATEGORIZATION