NCT05621538

A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Auburn University · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Alcohol Use Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2022-11-18
• Last updated: 2025-10-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study