CNT: A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder

Sponsor

Auburn University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05621538

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder	Behavioral: Realtime fMRI Neurofeedback - Active Device: TMS - Active Behavioral: Realtime fMRI Neurofeedback - Yoked Sham Device: TMS - Sham	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

The PI will prospectively assign treatment groups with blind codes and so will not be blind to treatment type. Other staff, who are the individuals primarily working with the patients and who will be conducting follow-up interviews, will be blind to treatment type. It is not possible to blind the 5th condition (treatment as usual with a brief check-in).

Primary Purpose:

Treatment

Official Title:

A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jan 31, 2025

Anticipated Study Completion Date :

Jan 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
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)	Behavioral: Realtime fMRI Neurofeedback - Active fMRI aided reinforcement of craving regulation Device: TMS - Active rTMS to right dorsolateral prefrontal cortex to reduce craving Other Names: Magventure Magpro
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)	Behavioral: Realtime fMRI Neurofeedback - Active 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
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)	Device: TMS - Active rTMS to right dorsolateral prefrontal cortex to reduce craving Other Names: Magventure Magpro 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
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)	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
No Intervention: Check-In Only 4 sessions of: Completing typical pre-TMS/MRI procedures Being prompted to reflect on outside treatment (TAU)

Outcome Measures

Primary Outcome Measures

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 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 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 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
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 19-65
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
Actively withdrawing from alcohol
Family history of schizophrenia or presence of psychotic symptoms