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

Part of paid clinical trials in Tuscaloosa, Alabama.

Sponsor
University of Alabama, Tuscaloosa
Study ID
NCT07737652
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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

Key Dates

First listed
Jul 30, 2026
Start date
Oct 6, 2025
Status verified
Jul 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
61 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Standard Care + MCN
    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.
  • Active Comparator: Standard Care Alone
    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.

Primary Outcome Measure

Change in Substance Craving Scale (SCS) Score [ Time Frame: Baseline, Mid-Point (Week 6), and Post-Intervention (Week 12) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Capstone College of Nursing, 650 University Blvd, 35401 TuscaloosaTuscaloosaAlabama35401-

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By research site
Capstone College of Nursing, 650 University Blvd, 35401 Tuscaloosa· Tuscaloosa, AL

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