Combined real-time fMRI neurofeedback and TMS for alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults ages 19–65 who are receiving treatment for alcohol use disorder come to an initial visit and then once weekly for four weeks for an intervention session that may include real-time fMRI neurofeedback, TMS, or sham versions of those interventions. Sessions are designed as supplemental, and the intervention arms include active and yoked-sham neurofeedback and active and sham TMS. Participants are followed monthly by remote contact for up to 12 months and asked to return for MRI follow-ups at 6 and 12 months. The protocol excludes people with MRI or TMS contraindications, active alcohol withdrawal, or psychotic illness or family history of schizophrenia.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 19-65
2. Receiving treatment for Alcohol Use Disorder

Exclusion Criteria:

1. MRI Contraindications

   1. Presence of metal in the body that would make having a 7T MRI unsafe (including facial tattoos)
   2. Claustrophobia, such that individual would be unable to stay in the MRI for up to 1 hr
   3. Hearing loss, including tinnitus, that might be made worse by MRI or TMS
2. TMS Contraindications

   1. Has ever had a seizure, or has a family history of epilepsy
   2. Taking medications or substances that lower the seizure threshold
   3. Implanted devices that are in the head or rely on physiological signals
   4. History of neurological disease, such as stroke or brain tumor
   5. Head injury with loss of consciousness greater than 30 minutes
   6. Actively withdrawing from alcohol
3. Family history of schizophrenia or presence of psychotic symptoms

Where it's running

• Auburn University
  Auburn, Alabama, United States Recruiting

Study contacts

• Principal investigator: Samantha J Fede, PhD — Auburn University
• Study coordinator: SCAMPI Lab
• Email: scampi@auburn.edu
• Phone: 334-521-2807

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.