Actively Recruiting
A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder
Led by Auburn University · Updated on 2025-10-07
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Auburn University
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a combined neurofeedback and transcranial magnetic stimulation (TMS) intervention for individuals receiving treatment for Alcohol Use Disorder. This study aims to assess how these techniques may influence alcohol use, craving, community functioning, employment status, aggression, antisocial behavior, and brain activity over time. Participants will be randomly assigned to one of several groups receiving four weekly sessions of different combinations of active or sham TMS and neurofeedback using fMRI. The TMS involves 10 Hz pulses delivered to the right dorsolateral prefrontal cortex. Neurofeedback sessions provide real-time brain activity information either from the participant or others. A control group will receive typical treatment without TMS or neurofeedback. Participants will attend an initial visit followed by weekly intervention sessions for four weeks. Monthly remote follow-ups will occur for up to 12 months, with MRI follow-ups at 6 and 12 months. Researchers will measure changes in alcohol use, craving, social and employment outcomes, behavior, and brain structure and function throughout the study period. Safety and adherence will be monitored continuously.
CONDITIONS
Brief Title
A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 to 65 years
- Currently receiving treatment for Alcohol Use Disorder
You will not qualify if you...
- Presence of metal in the body that would make having a 7T MRI unsafe, including facial tattoos
- Claustrophobia preventing staying in the MRI for up to 1 hour
- Hearing loss or tinnitus that could worsen with MRI or TMS
- History of seizures or family history of epilepsy
- Taking medications or substances that lower seizure threshold
- Implanted devices in the head or relying on physiological signals
- History of neurological disease such as stroke or brain tumor
- Head injury with loss of consciousness greater than 30 minutes
- Actively withdrawing from alcohol
- Family history of schizophrenia or presence of psychotic symptoms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive up to 4 sessions combining neurofeedback and transcranial magnetic stimulation (TMS) to reduce alcohol craving and use.
Weekly visits for 4 weeks
Duration - Up to 52 weeks after treatment
Participants are assessed periodically to monitor changes in alcohol use, craving, brain activity, and related outcomes after treatment ends.
Visits at Weeks 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, and 57
Trial Site Locations
Total: 1 location
1
Auburn University
Auburn, Alabama, United States, 36849
Actively Recruiting
Research Team
S
SCAMPI Lab
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
5
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