A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alcohol Use Disorder
- Sponsor
- Auburn University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change in Brain Activity during Alcohol Cue Presentation over Time
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
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.
Investigators
Samantha Fede
Assistant Professor
Auburn University
Eligibility Criteria
Inclusion Criteria
- •Receiving treatment for Alcohol Use Disorder
Exclusion Criteria
- •MRI Contraindications
- •Presence of metal in the body that would make having a 7T MRI unsafe (including facial tattoos)
- •Claustrophobia, such that individual would be unable to stay in the MRI for up to 1 hr
- •Hearing loss, including tinnitus, that might be made worse by MRI or TMS
- •TMS Contraindications
- •Has ever had a seizure, or has a family history of epilepsy
- •Taking medications or substances that lower the seizure threshold
- •Implanted devices that are in the head or rely on physiological signals
- •History of neurological disease, such as stroke or brain tumor
- •Head injury with loss of consciousness greater than 30 minutes
Outcomes
Primary Outcomes
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)
Measured via fMRI; standard alcohol cue reactivity
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)
Measured via fMRI; alcohol-cued sociomoral processing
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)
Alcohol Timeline Followback (alc-TLFB)
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)
Drinker Inventory of Consequences (DrInC)
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)
Alcohol Craving Questionnaire (ACQ)
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)
self-reported employment status
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)
Revised Conflict Tactics Scales (CTS-R)
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)
number of self-reported contacts with the police, convictions, and other criminal behaviors
Secondary Outcomes
- Change in Brain Gray Matter Structure over Time(Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups))
- Change in Resting State Functional Connectivity over Time(Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups))
- Change in Brain White Matter Structure over Time(Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups))