A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder

Not Applicable

Not yet recruiting

• Conditions: Alcohol Use Disorder
• Interventions: Behavioral: Realtime fMRI Neurofeedback - Active; Device: TMS - Active; Device: TMS - Sham; Behavioral: Realtime fMRI Neurofeedback - Yoked Sham

• Registration Number: NCT05621538
• Lead Sponsor: Auburn University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-11-10
• Study First Posted: 2022-11-18
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-15
• Study Start: 2024-01-31
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Neurofeedback-active + TMS-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)
Neurofeedback-active + TMS-active	Realtime fMRI Neurofeedback - 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)
Neurofeedback-active + TMS-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 own brain activity from multiple ROIs measured using fMRI)
Neurofeedback-sham + TMS-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)
Neurofeedback-active + TMS-sham	Realtime fMRI Neurofeedback - Active	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)
Neurofeedback-sham + TMS-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 other's brain activity from multiple ROIs measured using fMRI)
Neurofeedback-sham + TMS-active	Realtime fMRI Neurofeedback - Yoked Sham	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)
Neurofeedback-sham + TMS-sham	Realtime fMRI Neurofeedback - Yoked 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)

Primary Outcome Measures

Name	Time	Method
Change in Brain Activity during Alcohol Cue Presentation over Time	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	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	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	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	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	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	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	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 Outcome Measures

Name	Time	Method
Change in Brain Gray Matter Structure over Time	Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)	Measured via MRI; gray matter volume
Change in Resting State Functional Connectivity over Time	Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)	Measured via fMRI
Change in Brain White Matter Structure over Time	Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)	Measured via MRI; white matter diffusion

Trial Locations

Locations (1)

Auburn University; 🇺🇸 Auburn, Alabama, United States