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A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder

NCT05621538 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-10-07

No results posted yet for this study

Summary

The goal of this clinical study is to test the effectiveness of a supplemental fMRI neurofeedback and/or TMS intervention in individuals seeking treatment for Alcohol Use Disorder.

After an initial visit, participants will come in once a week for four (4) weeks for an intervention session, which may or may not include TMS and MRI. Participants will be contacted for monthly follow-ups (remotely) for up to 12 months and will be asked to come in for two MRI follow-ups at 6 and 12 months.

Conditions

Interventions

BEHAVIORAL

Realtime fMRI Neurofeedback - Active

fMRI aided reinforcement of craving regulation

DEVICE

TMS - Active

rTMS to right dorsolateral prefrontal cortex to reduce craving

BEHAVIORAL

Realtime fMRI Neurofeedback - Yoked Sham

Display of feedback from other participant's sessions to serve as a sham for fMRI aided reinforcement of craving regulation

DEVICE

TMS - Sham

rTMS using placebo coil (no brain stimulation, emulates other features of active TMS), placed over right dorsolateral prefrontal cortex

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Auburn University

    lead OTHER

Principal Investigators

  • Samantha J Fede, PhD · Auburn University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-03-31
Completion
2026-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05621538 on ClinicalTrials.gov