| Coverage Policy Manual | |
| Policy #: | 2011070 |
| Category: | Medicine |
| Initiated: | October 2011 |
| Last Review: | March 2024 |
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| Electrical Stimulation, Auricular Stimulation and Cranial Electrotherapy Stimulation | |
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| 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, have been developed to 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, and functional constipation. Auricular electrical stimulation is being evaluated for a variety of conditions, including pain, insomnia, depression, anxiety, weight loss, and opioid withdrawal.
Interest in cranial electrotherapy stimulation (CES) began in the early 1900s with 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 U.S. 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 a period of 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 pre-programmed 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 received marketing clearance through the U.S. Food and Drug Administration’s (FDA) 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 below.
FDA product code: QJQ
Cranial Electrotherapy Stimulation Devices Cleared by the U.S. Food and Drug Administration for insomnia, depression, and anxiety:
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 below.
FDA product codes: BWK, PZR.
Cranial Electrotherapy Stimulation Devices Cleared by the U.S. Food and Drug Administration
Coding
There are no CPT codes that are specific to electrical stimulation of auricular acupuncture points. The following CPT codes might be used:
97813: Acupuncture, 1 or more needles; with electrical stimulation, initial 15 minutes of personal one-on-one contact with the patient
97814: with electrical stimulation, each additional 15 minutes of personal one-on-one contact with the patient, with re-insertion of needle(s) (List separately in addition to code for primary procedure).
The following specific HCPCS code for auricular stimulation became effective April 1, 2012:
S8930: Electrical stimulation of auricular acupuncture points; each 15 minutes of personal one-on-one contact with the patient.
RELATED POLICIES:
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Policy/ Coverage: |
Effective July 2018
This service is a specific contract exclusion in most member benefit certificates of coverage and is not covered.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
For members with contracts without this specific contract exclusion, electrical stimulation of auricular acupuncture points does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without this specific contract exclusion and without primary coverage criteria, electrical stimulation of auricular acupuncture points is considered investigational. Investigational services are considered specific contract exclusions in most member benefit certificates of coverage.
For members with contracts without this specific contract exclusion, cranial electrotherapy stimulation (also known as cranial electrostimulation therapy or CES) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without this specific contract exclusion and without primary coverage criteria, cranial electrotherapy stimulation (also known as cranial electrostimulation therapy or CES) is investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to July 2018
This service is a specific contract exclusion in most member benefit certificates of coverage and is not covered.
For members with contracts without this specific contract exclusion, electrical stimulation of auricular acupuncture points does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without this specific contract exclusion and without primary coverage criteria, electrical stimulation of auricular acupuncture points is considered investigational. Investigational services are considered specific contract exclusions in most member benefit certificates of coverage.
For members with contracts without this specific contract exclusion, cranial electrotherapy stimulation (also known as cranial electrostimulation therapy or CES) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without this specific contract exclusion and without primary coverage criteria, cranial electrotherapy stimulation (also known as cranial electrostimulation therapy or CES) is investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective prior to October 2013
Electrical stimulation of auricular acupuncture points does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, electrical stimulation of auricular acupuncture points is considered investigational. Investigational services are considered specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
At the time this policy was created, use of the P-Stim had been reported only in European trials. In 2004, Sator-Katzenschlager et al. reported a randomized double-blind controlled study of auricular electro-acupuncture compared to conventional manual auricular acupuncture in 61 patients with chronic low back pain (duration of at least 6 months) (Sator-Katzenschlager, 2004). 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 using visual analog scale (VAS). There was a significant improvement in pain at up to 18 weeks’ follow-up. Auricular electro-acupuncture resulted in greater improvement in the outcome measures than that of the control group. For example, at 18-week follow-up, VAS pain intensity was less than 5 in the control group and less than 2 in the electro-acupuncture. This study is limited by the small number of participants. In 2003, this group of investigators had reported similar effects in a small randomized study of 21 patients with chronic cervical pain (Sator-Katzenschlager, 2003).
In another European study from 2008, Bernateck et al. reported the use of the P-Stim device in a randomized controlled trial (RCT) of 44 patients with rheumatoid arthritis (Bernateck, 2008). The control group received autogenic training, a psychological intervention in which participants learn to relax their limbs, breathing, and heart. Electro-acupuncture (continuous stimulation for 48 hours at home) and lessons in autogenic training were performed once weekly for 6 weeks. In addition, 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 study through 3 months of follow-up. The primary outcome measures were the mean weekly pain intensity and the disease activity score (DAS-28). At the end of treatment and at 3-month follow-up, a statistically significant improvement was observed in all outcome measures for both groups. There was greater improvement in the electro-acupuncture group than the control group (e.g., VAS pain 2.79 vs. 3.95) during the treatment period. This difference did not persist at the 3-month follow-up. The clinical significance of a 1-point difference in VAS from this small trial is unclear.
In a 2007 review, Sator-Katzenschlager and Michalek-Suberer found that studies on the use of the P-Stim in acute pain (e.g., oocyte aspiration and molar tooth extraction) are contradictory (Sator-Katzenschlager). A 2011 randomized trial from Europe tested the efficacy of the P-Stim in 40 female patients undergoing gynecologic surgery (Holzer, 2011). Patients were randomly assigned to receive 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 the operation 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 1,000 mg paracetamol every 6 hours, with additional piritramide 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 vs. placebo: 15.3 mg vs. 13.9 mg, respectively) or on VAS scores taken at 0, 2, 24, 48, and 72 hours (average of 2.32 vs. 2.62, acupuncture vs. placebo, respectively).
Summary
The evidence available at this time is insufficient to evaluate the effect of auricular electrostimulation on health outcomes, including acute and chronic pain. Additional randomized studies with a larger number of subjects are needed to evaluate the efficacy of this treatment approach.
2012 Update
A search of the MEDLINE database through September 2012 identified no published literature that would prompt a change in the coverage statement.
Napadow and colleagues (2012) published a counter balanced, crossover study. The patients in the study had chronic pelvic pain (CPP) due to endometriosis. Interventions included the evaluation of evoked pain analgesia for respiratory-gated auricular vagal afferent nerve stimulation (RAVANS) compared with nonvagal auricular stimulation (NVAS). RAVANS and NVAS were evaluated in separate sessions spaced at least 1 week apart. Outcome measures included deep-tissue pain intensity, temporal summation of pain, and anxiety ratings, which were assessed at baseline, during active stimulation, immediately following stimulation, and 15 minutes after stimulus cessation.
Results of the study: RAVANS demonstrated a trend for reduced evoked pain intensity and temporal summation of mechanical pain, and significantly reduced anxiety in N = 15 CPP patients, compared with NVAS, with moderate to large effect sizes (η(2) > 0.2).
In summary, chronic pain disorders such as CPP are in great need of effective, nonpharmacological options for treatment. RAVANS produced promising antinociceptive effects for quantitative sensory testing (QST) outcomes reflective of the noted hyperalgesia and central sensitization in this patient population. Future studies should evaluate longer-term application of RAVANS to examine its effects on both QST outcomes and clinical pain.
The following clinical trial was listed on clinicaltrials.gov: NCT01278355 - The Feasibility of Integrating Ear Acupuncture for Pain in Patients Being Transported Via the Aeromedical Evacuation System From Ramstein Air Base to Andrews AFB, Maryland USA: An Observational Study is still recruiting.
2013 Update
A search of the MEDLINE database was conducted through September 2013. There was no new information identified on the use of auricular electrostimulation that would prompt a change in the coverage statement. This update focuses on the use of cranial electrotherapy stimulation.
Cranial Electrotherapy Stimulation (CES)
A number of randomized controlled trials and systematic reviews have been published on CES. In 1995, Klawansky et al. published a meta-analysis of 14 randomized trials of CES versus sham (Klawansky, 1995). Most of the studies were small, with fewer than 50 patients. Meta-analysis was conducted for the treatment of 4 different psychological and physiological conditions: anxiety (8 trials), brain dysfunction from drug or alcohol use (2 trials), headache (2 trials), and insomnia (2 trials). Meta-analysis showed CES to be significantly more effective than sham for anxiety and headache. Of the 8 studies included in the meta-analysis for anxiety, the sample size was generally small, the populations studied were diverse, and only 2 of the studies independently showed CES to be better than sham treatment. For headache, there was a high risk of bias for 1 of the studies and a poor quality rating for the second according to a Cochrane review (see below) (Bronfort, 2004). Meta-analysis did not find CES to be more effective than sham for brain dysfunction or insomnia.
Anxiety: The largest randomized study on anxiety that was included in the 1995 systematic review was a 1976 report by Passini et al (Passini, 1976). Sixty psychiatric patients with a variety of diagnoses (e.g., alcohol addiction, unipolar depression, bi-polar disorder, anxiety, schizophrenia, personality disorder) and with either anxiety or depression were included. Thirty-minute treatments on 10 successive workdays resulted in significant improvements in both the CES and sham groups on self-ratings of anxiety, depression, and hostility, indicating a large placebo effect. Improvements were not significantly different between the groups, but tended to favor the controls rather than the active CES group.
Headache: A 2009 Cochrane review of non-invasive treatments for headaches identified 2 poor quality randomized placebo controlled trials on CES for migraine or tension-type headache (Bronfort, 2004). The trials provided limited evidence that CES is superior to placebo in reducing pain intensity from headache.
Chronic Pain: A 2010 Cochrane review of non-invasive brain stimulation techniques for chronic pain identified 8 randomized trials (5 parallel study design and 3 cross-over design with a total of 391 participants) (O’Connell, 2010). Chronic pain conditions included osteoarthritis of the hip and knee, chronic back and neck pain, fibromyalgia, and chronic pain following spinal cord injury. Meta-analysis of 3 trials (133 participants) where it was possible to extract data, found no difference between active CES and sham stimulation on pain at short-term follow-up, leading to the conclusion that CES may be ineffective for chronic pain.
In 2011, Tan et al. published a multi-center randomized double-blind sham-controlled trial of CES for chronic neuropathic pain following spinal cord injury (Tan, 2011). The study of 105 participants was funded by the Veterans Affairs Rehabilitation Research and Development Service. Sub-perception CES or sham CES was applied for 1 hour daily at home over 21 days, followed by a 6-month open-label phase to assess “as needed” CES usage. The primary outcome measure was daily pre- to post-session changes in pain ratings. The active and sham groups did not differ significantly on average daily pain ratings before (active=5.60, sham=5.41) or after treatment (active=5.00, sham=5.00), but the active CES group had a statistically greater decrease in pain (0.60 vs. 0.41). This is not a clinically significant difference. The only outcome measure that showed a significant group by time interaction after 21 days of treatment was pain interference, although this measure was not comparable between the groups at baseline. Baseline to post-treatment changes in pain intensity, pain quality, pain beliefs and coping strategies, general physical and mental health status, depressive symptomatology, perceived stress, and anxiety did not differ between groups. Eighteen participants (17%) reported that they were using the device by the sixth month of the open-label phase.
Parkinson’s Disease: Shill et al. found no benefit of CES with the Nexalin device for motor or psychological symptoms in a crossover study of 23 patients with early Parkinson’s disease (Shill, 2011).
Smoking Cessation: In 1997, Pickworth et al. reported that 5 days of CES was ineffective for reducing withdrawal symptoms or facilitating smoking cessation in a double-blind randomized controlled trial of 101 cigarette smokers who wished to stop smoking (Pickworth, 1997).
In summary, a number of randomized double-blind sham-controlled trials along with several systematic reviews have been conducted on CES for a variety of conditions. In spite of the number of trials, there is a lack of evidence for improvement of health outcomes.
2014 Update
A literature search conducted through August 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Anxiety and Depression
In 2014, Barclay and Barclay reported a randomized, double-blind, sham controlled trial of the effectiveness of one hour daily of CES in patients with anxiety (n=115) and co-morbid depression (n=23) (Barclay, 2014). Analysis of covariance showed a significant advantage of active CES over sham for both anxiety (p=.001) and depression (p=.001) over the 5 weeks of treatment. The mean decrease in the Hamilton rating scale for anxiety was 32.8% for active CES versus 9.1% for sham. The mean decrease in the Hamilton rating scale for depression was 32.9% for active CES and 2.6% for sham.
A 2014 Cochrane review with a literature search through February 2014 found no high quality randomized
controlled trials of CES versus sham for the treatment of depression (Kavirajan, 2014).
Chronic Pain
A 2014 update of the Cochrane review identified 11 randomized trials of CES for chronic pain (O'Connell, 2014). Metaanalysis of 6 trials (270 participants) found no significant difference between active and sham stimulation, reinforcing the conclusion that CES is not effective for the treatment of chronic pain.
Obesity
The same group of investigators reported a randomized double-blinded study of the effects of the P-Stim on weight loss in 56 obese patients (Schukro, 2014). The auricular acupuncture points for hunger, stomach, and colon were stimulated for 4 days per week over 6 weeks. At the end of treatment, body weight was reduced by 3.73% in the active stimulation group and .70% in the sham group (p<.001). From the beginning of treatment to 4 weeks after the end of treatment, body weight was reduced by 5.08% in the active stimulation group and .16% in the sham group (p<.001). Similar changes were observed for BMI (body mass index) and body fat. Further study by these investigators will include a larger sample size and a longer time of observation.
The positive effect of electrostimulation that was reported for weight loss requires confirmation in a larger sample of patients. The evidence available at this time is insufficient to determine the effect of auricular electrostimulation on health outcomes, including acute and chronic pain and weight loss.
2015 Update
A literature search conducted through July 2015 did not reveal any new information that would prompt a change in the coverage statement.
2016 Update
A literature search conducted through August 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
In contrast, a 2015 sham-controlled, double-blind RCT found no significant benefit of CES with the Alpha-Stim for symptoms of depression, anxiety, pain, fatigue, and sleep disturbances in women receiving chemotherapy for breast cancer (Lyon, 2015). This phase 3 trial randomized 167 women with early stage breast cancer to 1 h daily CES or sham stimulation beginning within 48 hours of the first chemotherapy session and continuing until 2 weeks after chemotherapy ended (range, 6-32 weeks). The intensity of the stimulation was below the level of sensation. Active and sham devices were preset at the factory and neither the evaluators nor patients were aware of the treatment condition. 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 study may be limited by the low levels of symptoms at baseline, resulting in a floor effect, and the low level of stimulation.
Another smaller double-blind, sham-controlled RCT (N=30) found no significant benefit of a CES as an add-on in patients with treatment-resistant major depression (Mischoulon, 2015). Both the active and sham groups showed improvements in depression over the 3 weeks of the study, suggesting a strong placebo effect.
2017 Update
A literature search conducted through August 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Roh and So reported on a sham-controlled randomized trial (N=50) in healthy women with a focus on changes in blood levels of hormones related to the hypothalamic-pituitary axis (Roh, 2016). However, given that this trial did not include outcomes for individuals with anxiety or depression, it is unclear whether results would be generalizable.
Gong and colleagues reported a single-center, unblinded RCT comparing CES (Alpha-Stim) with biofeedback in 74 subjects with functional constipation (Gong, 2016). 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 does not seem to have been 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 for the following: Self-Rating Anxiety Scale results (for third visit: 41.8 for CES patients vs 46.8 for controls; p<0.001); Self-Rating Depression Scale results (for third visit: 43.08 for CES patients vs 48.8 for controls; p<0.001) and the Wexner Constipation Score results (for third visit: 10.0 for CES patients vs 12.6 for controls; p<0.001). A subset of patients underwent anorectal manometry, and there were no between-group differences before or after treatment.
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Obesity
Yeh et al randomized 70 patients to electrical stimulation on true acupressure points or sham acupressure points (Yeh, 2015). 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.
Opioid Withdrawal Symptoms
Evidence on the use of auricular electrostimulation to treat patients with opioid withdrawal symptoms consists of 2 case series with different protocols. Both studies reported successful alleviation of opioid withdrawal symptoms, though, without comparators, conclusions to be drawn from this evidence are limited. These case series are described below.
Kroening and Oleson published a case series assessing 14 patients with chronic pain who were scheduled for withdrawal from their opiate medications (Kroening, 1985). 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 conducted an open-label, uncontrolled, retrospective pilot study to evaluate the effect of neuromodulation with percutaneous electrical field stimulation on opioid withdrawal symptoms (Miranda, 2018). 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 Bridge 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. Mean baseline COWS score was 20.1. At 20 minutes, mean COWS score decreased to 7.5; at 30 minutes, mean COWS was 4.0; and at 60 minutes, mean COWS was 3.1. At 5-day follow-up, 89% of patients successfully transitioned to maintenance medication.
2019 Update
A literature search was conducted through June 2019. There was no new information identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
The results of a systematic review and meta-analysis were published by Kim et al (Kim, 2018). 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 (LM) was more effective than LM alone (Hedges’ g = 1.104, 95% CI = 0.531–1.678) and sham acupuncture plus LM (Hedges’ g = 0.324, 95% CI = 0.177–0.471), whereas acupuncture alone was not more effective than sham acupuncture alone and no treatment. Interestingly, acupuncture treatment was effective only in subjects with overweight (25 ≤ body mass index < 30, Hedges’ g = 0.528, 95% CI = 0.279–0.776), not in subjects with obesity (body mass index ≥30). Auricular acupuncture (Hedges’ g = 0.522, 95% CI = 0.152–0.893), manual acupuncture, (Hedges’ g = 0445, 95% CI = 0.044–0.846) and pharmacopuncture (Hedges’ g = 0.411, 95% CI = 0.026–0.796) also were aligned with weight loss.
2020 Update
A literature search was conducted through June 2020. There was no new information identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Miranda and Taca conducted an open-label, uncontrolled, retrospective pilot study to evaluate the effect of neuromodulation with percutaneous electrical field stimulation on opioid withdrawal symptoms (Miranda and Taca, 2018). 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 Bridge 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. Mean baseline COWS score was 20.1. At 20 minutes, mean COWS score decreased to 7.5; at 30 minutes, mean COWS was 4.0; and at 60 minutes, mean COWS was 3.1. At 5-day follow-up, 89% of patients successfully transitioned to maintenance medication.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Ahn et al 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 (Ahn, 2020). Mean age was 59.43 years. CES was delivered via the Alpha-Stim M Stimulator, which was preset at 01 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.
Wu et al 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 (Wu, 2020). CES 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).
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
More recently, Price et al (2021) published a meta-analysis evaluating CES for the treatment of depression and/or anxiety and depression (Price, 2021). 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.
Kim et al 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 (Kim, 2021). 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.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2023. No new literature was identified that would prompt a change in the coverage statement.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
The Alpha-Stim Anxiety Insomnia and Depression (AID) device was evaluated in the multicenter, double-blind Alpha-Stim-D RCT (Patel, 2022; Morriss, 2023). 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.
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| References: |
Ahn H, Galle K, Mathis KB, et al.(2020) 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 Barclay TH, Barclay RD.(2014) A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression. J Affect Disord. Aug 2014;164:171-177. PMID 24856571 Bernateck M, Becker M, Schwake C et al.(2008) Adjuvant auricular electroacupuncture and autogenic training in rheumatoid arthritis: a randomized controlled trial. Auricular acupuncture and autogenic training in rheumatoid arthritis. Forsch Komplementmed 2008; 15(4):187-93. Bronfort G, Nilsson N, Haas M et al.(2004) Non-invasive physical treatments for chronic/recurrent headache. Cochrane Database Syst Rev 2004; (3):CD001878. 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