A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder (CNT)

Auburn University

Status: Enrolling

Conditions: Alcohol Use Disorder

Treatments: Behavioral: Realtime fMRI Neurofeedback - Active; Behavioral: Realtime fMRI Neurofeedback - Yoked Sham; Device: TMS - Sham; Device: TMS - Active

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05621538

R00AA027830 (U.S. NIH Grant/Contract)

22145

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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90 participants in 5 patient groups

Neurofeedback-active + TMS-active

Experimental group

Description:

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)

Treatment:

Device: TMS - Active

Behavioral: Realtime fMRI Neurofeedback - Active

Neurofeedback-active + TMS-sham

Active Comparator group

Description:

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)

Treatment:

Device: TMS - Sham

Behavioral: Realtime fMRI Neurofeedback - Active

Neurofeedback-sham + TMS-active

Active Comparator group

Description:

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)

Treatment:

Device: TMS - Active

Behavioral: Realtime fMRI Neurofeedback - Yoked Sham

Neurofeedback-sham + TMS-sham

Sham Comparator group

Description:

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)

Treatment:

Device: TMS - Sham

Behavioral: Realtime fMRI Neurofeedback - Yoked Sham

Check-In Only

No Intervention group

Description:

4 sessions of: Completing typical pre-TMS/MRI procedures Being prompted to reflect on outside treatment (TAU)