A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

— CNT  

Official title:

A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05621538
• Other study ID #: 22145
• Secondary ID: R00AA027830
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 31, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: December 2023
• Source: Auburn University
• Contact: SCAMPI Lab
• Phone: 334-521-2807
• Email: scampi[@]auburn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• Realtime fMRI Neurofeedback - Active
fMRI aided reinforcement of craving regulation

Device:
• TMS - Active
rTMS to right dorsolateral prefrontal cortex to reduce craving

Behavioral:
• 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

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

Locations

Country	Name	City	State
United States	Auburn University	Auburn	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Auburn University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Alcohol Use over Time	Alcohol Timeline Followback (alc-TLFB)	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)
Primary	Change in Alcohol Craving over Time	Alcohol Craving Questionnaire (ACQ)	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)
Primary	Change in Community Functioning over Time	Drinker Inventory of Consequences (DrInC)	Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
Primary	Change in Employment Status over Time	self-reported employment status	Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
Primary	Change in Aggression and Victimization over Time	Revised Conflict Tactics Scales (CTS-R)	Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups)
Primary	Change in Antisocial Behavior over Time	number of self-reported contacts with the police, convictions, and other criminal behaviors	Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups)
Primary	Change in Brain Activity during Alcohol Cue Presentation over Time	Measured via fMRI; standard alcohol cue reactivity	Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Primary	Change in Brain Activity during Simultaneous Sociomoral & Alcohol Cue Presentation over Time	Measured via fMRI; alcohol-cued sociomoral processing	Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Secondary	Change in Brain Gray Matter Structure over Time	Measured via MRI; gray matter volume	Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Secondary	Change in Brain White Matter Structure over Time	Measured via MRI; white matter diffusion	Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Secondary	Change in Resting State Functional Connectivity over Time	Measured via fMRI	Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)