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Microcurrent Neurofeedback as an Adjunct to Standard Care for Substance Use Disorders

Microcurrent Neurofeedback as an Adjunct to Standard Care for Substance Use Disorders: A Single-Site Pilot Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07737652
Enrollment
61
Registered
2026-07-30
Start date
2025-10-06
Completion date
2026-06-30
Last updated
2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Post Traumatic Stress Disorder, Substance Use Disorder (SUD)

Keywords

Microcurrent Neuorfeedback, PTSD, Anxiety, Neurofeedback, IASIS, Craving, Depression, Substance Use Disorder, Addiction Treatment, Residential Treatment, Polysubstance Use, Pilot study, Feasibility, Substance Craving Scale, Opioid Use Disorder

Brief summary

The goal of this clinical trial is to learn whether adding Microcurrent Neurofeedback (MCN) to standard residential treatment helps adults with substance use disorder more than standard treatment alone. It will also learn whether MCN is feasible to deliver in a residential treatment setting. The main questions it aims to answer are: Does adding MCN to Standard Care reduce substance cravings more than Standard Care alone? Does adding MCN to Standard Care reduce symptoms of depression, anxiety, and PTSD more than Standard Care alone? Is it feasible to deliver MCN sessions and collect study measurements within a residential treatment program? Researchers compared Standard Care plus MCN to Standard Care alone to see whether adding MCN improved outcomes beyond standard treatment. Participants: Were enrolled in residential substance use treatment for at least 4 weeks before joining the study Were randomly assigned to receive Standard Care plus MCN or Standard Care alone Those receiving MCN attended 12 sessions over 12 weeks, each lasting 30-45 minutes Completed questionnaires about cravings, depression, anxiety, and PTSD symptoms at the start of the study, at 6 weeks, and at 12 weeks

Detailed description

Substance use disorder (SUD) affects millions of adults in the United States, and many people who receive treatment continue to struggle with cravings and co-occurring symptoms of depression, anxiety, and post-traumatic stress disorder (PTSD), even in intensive residential treatment programs. Standard residential treatment typically includes medication (when appropriate), individual and group therapy, and peer support, but craving often persists despite these approaches, leaving room to explore additional treatments that might help. Microcurrent Neurofeedback (MCN) is a non-invasive technology that uses a person's own brainwave activity (EEG) to guide very low-intensity electrical stimulation delivered through sensors placed on the scalp. The goal is to help normalize patterns of brain activity that may be involved in craving and emotional distress. MCN has shown early promise in small studies for depression, anxiety, and PTSD in general (non-substance-use) populations, but before this study, no randomized trial had tested MCN specifically in adults being treated for substance use disorder. This study was conducted as a pilot and feasibility trial, meaning its main purpose was to generate early evidence and test whether this type of study could be carried out successfully in a residential treatment setting, rather than to provide a definitive answer about how well MCN works. Feasibility outcomes (such as how many people could be enrolled, how many completed the study, and whether the MCN sessions could be delivered as planned) were considered just as important as the clinical outcomes. Adults enrolled in residential substance use treatment at a partner treatment facility were invited to participate after completing a required 4-week stabilization period in the program. Eligible participants were randomly assigned, similar to a coin flip, to one of two groups: Standard Care plus MCN, or Standard Care alone. Random assignment helps ensure the two groups are similar at the start of the study, so that any differences seen later are more likely due to the treatment itself rather than pre-existing differences between participants. Participants assigned to receive MCN attended 12 sessions over 12 weeks, each lasting 30 to 45 minutes, delivered by trained staff in a private room at the treatment facility. Because of the nature of the treatment, participants and staff could not be blinded to which group a person was in (this is known as an open-label design). All participants, regardless of group, continued to receive their regular Standard Care throughout the study. All participants completed questionnaires about substance cravings, depression, anxiety, and PTSD symptoms at three points during the study: at the start (Baseline), at the midpoint (around 6 weeks), and at the end (around 12 weeks). These questionnaires are widely used, validated tools in mental health and addiction research. Because participants were enrolled in a residential treatment program, some left the program before completing the study, which is a known challenge in this type of research; the study's analysis approach was designed to account for this as much as possible. A subset of participants also had their brain activity recorded using EEG, and a smaller subset underwent MRI brain scans, to explore whether measurable changes in brain activity or structure accompanied any changes in symptoms. These neuroimaging findings are being analyzed and reported separately from the main clinical results. This study did not directly measure drug or alcohol use, relapse, or abstinence; it focused specifically on craving and psychiatric symptoms. Findings from this pilot study are intended to inform the design of a larger, more definitive future trial.

Interventions

DEVICEMicrocurrent Neurofeedback (MCN)

A noninvasive neurophysiological intervention using the IASIS device (Synaptic Tech, LLC), an FDA-cleared Class 2 biofeedback device (Product Code: HCC; Regulation 882.5050; K945826). The device delivers sub-sensory-threshold, low-intensity electrical pulses via scalp sensors placed according to a standardized EEG electrode-placement guide. Protocols are individualized to each participant's EEG profile via real-time monitoring, with stimulation targeted at brain regions implicated in craving and emotional dysregulation, including the anterior cingulate cortex and nucleus accumbens. This FDA clearance covers the device category and does not constitute clearance specifically for treating substance use disorder, craving, PTSD, depression, or anxiety; its use for these indications was investigational in this study. Participants in the experimental arm received 12 sessions (30-45 minutes each) over 12 weeks, twice weekly during alternating weeks, in addition to Standard Care.

BEHAVIORALStandard Care for Substance Use Disorder

Standardized program of care delivered throughout the 12-week study period per routine clinical practice at the residential treatment facility, including medications for opioid or alcohol use disorder where clinically indicated (MOUD), individual and group cognitive-behavioral therapy (CBT), 12-step facilitation, and psychosocial support services. Program structure was consistent across participants, though utilization of individual components, particularly medication receipt, varied according to clinical need (e.g., presence of an opioid use disorder). All participants, regardless of study arm, received Standard Care throughout the study period.

Sponsors

University of Alabama, Tuscaloosa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants were randomly assigned in a 1:1 ratio to one of two parallel arms: Standard Care plus Microcurrent Neurofeedback (MCN), or Standard Care alone. Randomization was stratified by substance use pattern (single-substance vs. polysubstance use). Both arms were followed concurrently over the same 12-week study period, with assessments at Baseline, Mid-Point (Week 6), and Post-Intervention (Week 12). Participants remained in their assigned arm for the duration of the study; there was no crossover between arms.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Age 18 to 65 years at enrollment Current substance use disorder (SUD) diagnosis of any substance type Active enrollment in a residential SUD treatment program, with a minimum of 4 weeks of program enrollment completed prior to study enrollment (stabilization period) Medically stable English proficiency Willingness and ability to provide written informed consent

Exclusion criteria

Severe cognitive impairment Active psychosis or acute psychiatric instability Neurological disorder likely to interfere with neurofeedback Concurrent enrollment in another interventional study Current receipt of another form of neurofeedback therapy

Design outcomes

Primary

MeasureTime frameDescription
Change in Substance Craving Scale (SCS) ScoreBaseline, Mid-Point (Week 6), and Post-Intervention (Week 12)The Substance Craving Scale (SCS; Somoza et al., 1995) is a three-item self-report instrument assessing the intensity, frequency, and duration of cravings for the participant's primary substance of use. Items are scored on a four-point scale, yielding a total score of 0 to 12, with higher scores indicating greater craving severity.

Secondary

MeasureTime frameDescription
Change in Patient Health Questionnaire-9 (PHQ-9) ScoreBaseline, Mid-Point (Week 6), and Post-Intervention (Week 12)he PHQ-9 (Kroenke et al., 2001) is a nine-item measure of depression symptom severity, with total scores ranging from 0 to 27. Higher scores indicate greater depression severity. Severity categories are minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).
Change in Generalized Anxiety Disorder 7-Item Scale (GAD-7) ScoreBaseline, Mid-Point (Week 6), and Post-Intervention (Week 12)The GAD-7 (Spitzer et al., 2006) is a seven-item measure of anxiety symptom severity, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety severity. Severity categories are minimal (0-4), mild (5-9), moderate (10-14), and severe (15-21).
Change in PTSD Checklist for DSM-5 (PCL-5) ScoreBaseline, Mid-Point (Week 6), and Post-Intervention (Week 12)The PCL-5 (Weathers et al., 2013) is a 20-item measure corresponding to DSM-5 PTSD diagnostic criteria, with total scores ranging from 0 to 80. Higher scores indicate greater PTSD symptom severity. A provisional PTSD diagnosis is indicated by a score of 33 or above.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOREvans F Kyei, PhD MSN, RN

The University of Alabama

PRINCIPAL_INVESTIGATORMercy N Mumba, PhD BSN

The University of Alabama

PRINCIPAL_INVESTIGATORSharlene Newman, PhD

The University of Alabama

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026