Recruiting

fMRI Neurofeedback & TMS

Sponsor:

Auburn University

Code:

NCT05621538

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 19 - 65

Healthy Volunteers: Not accepted

Interventions

Realtime fMRI Neurofeedback - Active

TMS - Active

Realtime fMRI Neurofeedback - Yoked Sham

TMS - Sham

Study Details

Brief 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

Study ID

NCT05621538

Start date

Oct 1, 2025

Status verified date

Oct, 2025

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Neurofeedback-active + TMS-active

4 sessions of: TMS (protocol: 10 Hz pulses delivered at 110% of MT in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of own brain activity from multiple ROIs measured using fMRI)

active comparator: Neurofeedback-active + TMS-sham

4 sessions of: TMS (protocol: 10 Hz pulses delivered using the Sham TMS coil in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of own brain activity from multiple ROIs measured using fMRI)

active comparator: Neurofeedback-sham + TMS-active

4 sessions of: TMS (protocol: 10 Hz pulses delivered at 110% of MT in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of other's brain activity from multiple ROIs measured using fMRI)

sham comparator: Neurofeedback-sham + TMS-sham

4 sessions of: TMS (protocol: 10 Hz pulses delivered using the Sham TMS coil in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of other's brain activity from multiple ROIs measured using fMRI)

no intervention: Check-In Only

4 sessions of: Completing typical pre-TMS/MRI procedures Being prompted to reflect on outside treatment (TAU)

Interventions

Realtime fMRI Neurofeedback - Active

fMRI aided reinforcement of craving regulation

TMS - Active

rTMS to right dorsolateral prefrontal cortex to reduce craving

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

TMS - Sham

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

Primary outcome measure

  • Change in Alcohol Use over Time [ Time Frame: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions, pre and post), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups) ]
  • Change in Alcohol Craving over Time [ Time Frame: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions, pre and post), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups) ]
  • Change in Community Functioning over Time [ Time Frame: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups) ]
  • Change in Employment Status over Time [ Time Frame: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups) ]
  • Change in Aggression and Victimization over Time [ Time Frame: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups) ]
  • Change in Antisocial Behavior over Time [ Time Frame: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups) ]
  • Change in Brain Activity during Alcohol Cue Presentation over Time [ Time Frame: Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups) ]
  • Change in Brain Activity during Simultaneous Sociomoral & Alcohol Cue Presentation over Time [ Time Frame: Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups) ]

Central Contacts and Locations

Central contacts

SCAMPI Lab

334-521-2807scampi@auburn.edu

Locations

Auburn University

Recruiting

Auburn, Alabama, United States, 36849

Contacts

SCAMPI Lab

334-521-2807scampi@auburn.edu

Principal Investigator:

Samantha J Fede, PhD

More Information

Sponsor

Auburn University

Last update posted

Oct 7, 2025

Last verified

Oct, 2025

Keywords

  • treatment seeking
  • alcohol
  • TMS
  • neurofeedback
  • supplemental intervention
  • heavy drinking
  • problems with drinking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Auburn University on 2025-10-07.