Clinical trial NCT05621538: A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder
Official title: A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: treatment seeking
alcohol
TMS
neurofeedback
supplemental intervention
heavy drinking
problems with drinking
Lead sponsor: Auburn University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-11-18
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Alcohol Use over Time
timeFrame: 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)
measure: Change in Alcohol Craving over Time
timeFrame: 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)
measure: Change in Community Functioning over Time
timeFrame: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
measure: Change in Employment Status over Time
timeFrame: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
measure: Change in Aggression and Victimization over Time
timeFrame: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups)
measure: Change in Antisocial Behavior over Time
timeFrame: Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups)
measure: Change in Brain Activity during Alcohol Cue Presentation over Time
timeFrame: Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
measure: Change in Brain Activity during Simultaneous Sociomoral & Alcohol Cue Presentation over Time
timeFrame: Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Secondary outcomes:
measure: Change in Brain Gray Matter Structure over Time
timeFrame: Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
measure: Change in Brain White Matter Structure over Time
timeFrame: Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
measure: Change in Resting State Functional Connectivity over Time
timeFrame: Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
Study officials:
affiliation: Auburn University
name: Samantha J Fede, PhD
role: PRINCIPAL_INVESTIGATOR
References: