Combined real-time fMRI neurofeedback and TMS for alcohol use disorder
A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder
This project tests whether adding real-time fMRI neurofeedback and/or transcranial magnetic stimulation (TMS) to usual treatment helps adults in treatment for alcohol use disorder reduce drinking and cravings.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 19 Years to 65 Years |
| Sex | All |
| Sponsor | Auburn University Academic / other |
| Locations | 1 site (Auburn, Alabama) |
| Trial ID | NCT05621538 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 19–65 who are currently receiving treatment for alcohol use disorder and can safely undergo MRI and TMS procedures are the intended participants.
Not a fit: People with MRI or TMS contraindications (metal implants, seizure history, active withdrawal), those with psychosis or family history of schizophrenia, or those not engaged in treatment are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could provide an additional non-pharmacologic option to help reduce drinking and cravings when added to standard treatment.
How similar studies have performed: Previous research on TMS or fMRI neurofeedback alone has shown mixed but sometimes promising effects on craving, while combined neurofeedback-plus-TMS interventions remain largely novel and less tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Auburn, Alabama
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.