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

NCT07737652 | Completed FDA Device

• 1 other identifier: UAIRB: 25-04-8568
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Conditions

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

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

Outcome Measures

Primary Outcomes (1)

• Change in Substance Craving Scale (SCS) Score

  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.

  Baseline, Mid-Point (Week 6), and Post-Intervention (Week 12)

Secondary Outcomes (3)

• Change in Patient Health Questionnaire-9 (PHQ-9) Score

  Baseline, Mid-Point (Week 6), and Post-Intervention (Week 12)

• Change in Generalized Anxiety Disorder 7-Item Scale (GAD-7) Score

  Baseline, Mid-Point (Week 6), and Post-Intervention (Week 12)

• Change in PTSD Checklist for DSM-5 (PCL-5) Score

  Baseline, Mid-Point (Week 6), and Post-Intervention (Week 12)

Study Arms (2)

Standard Care + MCN

EXPERIMENTAL

Participants received Standard Care (medications for opioid or alcohol use disorder where indicated, individual/group CBT, 12-step facilitation, and psychosocial support) plus 12 sessions of Microcurrent Neurofeedback (MCN) over 12 weeks, delivered twice weekly during alternating weeks. Sessions lasted 30-45 minutes and were conducted in a private room by trained, certified personnel using the IASIS device (Synaptic Tech, LLC), an FDA-cleared Class 2 biofeedback device. The device delivers sub-sensory-threshold electrical pulses via scalp sensors, with protocols individualized to each participant's EEG profile.

Device: Microcurrent Neurofeedback (MCN); Behavioral: Standard Care for Substance Use Disorder

Standard Care Alone

ACTIVE COMPARATOR

Participants received Standard Care only, consisting of 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, per routine clinical practice at the residential treatment facility. Program structure was consistent across participants, though utilization of individual components, particularly medication receipt, varied by clinical need.

Behavioral: Standard Care for Substance Use Disorder

Interventions

Microcurrent Neurofeedback (MCN) DEVICE

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.

Also known as: IASIS Microcurrent Neurofeedback (I-MCN), IASIS LIP-tES

Standard Care + MCN

Standard Care for Substance Use Disorder BEHAVIORAL

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.

Also known as: Treatment as Usual (TAU)

Standard Care + MCN; Standard Care Alone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead

Study Sites (1)

Capstone College of Nursing, 650 University Blvd, 35401 Tuscaloosa

Tuscaloosa, Alabama, 35401, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Substance-Related Disorders; Stress Disorders, Post-Traumatic; Opioid-Related Disorders

Interventions

Standard of Care; Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Chemically-Induced Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Narcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Evans F Kyei, PhD MSN, RN

  The University of Alabama

  PRINCIPAL INVESTIGATOR

• Mercy N Mumba, PhD BSN

  The University of Alabama

  PRINCIPAL INVESTIGATOR

• Sharlene Newman, PhD

  The University of Alabama

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start: October 6, 2025
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

US (1)