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

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

Interventions

DEVICE

Microcurrent 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.

BEHAVIORAL

Standard 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 & Collaborators

• University of Alabama, Tuscaloosa

  lead OTHER

Principal Investigators

• Evans F Kyei, PhD MSN, RN · The University of Alabama

• Mercy N Mumba, PhD BSN · The University of Alabama

• Sharlene Newman, PhD · The University of Alabama

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-06

Primary Completion

2026-06-30

Completion

2026-06-30

FDA Device

Yes

Countries

• United States

Study Locations