Neurofeedback + TMS for Alcoholism
(CNT Trial)

Recruiting in Palo Alto (17 mi)

Overseen bySamantha J Fede, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Auburn University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Samantha J Fede, PhD

Principal Investigator

Auburn University

Eligibility Criteria

This trial is for adults aged 19-65 who are currently receiving treatment for Alcohol Use Disorder. It's not suitable for those with significant head injuries, claustrophobia that prevents MRI scans, neurological diseases, seizure history, certain metal implants or body metal including facial tattoos, medications lowering seizure threshold, active alcohol withdrawal symptoms, hearing loss worsened by MRI/TMS or a family history of schizophrenia.

Inclusion Criteria

Receiving treatment for Alcohol Use Disorder

I am between 19 and 65 years old.

Exclusion Criteria

TMS Contraindications

I have a medical device implanted in my head or one that uses body signals.

MRI Contraindications

See 9 more

Treatment Details

Interventions

Realtime fMRI Neurofeedback - Active (Behavioral Intervention)
Realtime fMRI Neurofeedback - Yoked Sham (Behavioral Intervention)
TMS - Active (Device)
TMS - Sham (Device)

Trial OverviewThe study tests if additional fMRI neurofeedback and TMS (Transcranial Magnetic Stimulation) can help people being treated for Alcohol Use Disorder. Participants will undergo weekly sessions over four weeks and have follow-ups via remote contact monthly up to one year with two extra MRI sessions at six and twelve months.

Participant Groups

5Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Neurofeedback-active + TMS-activeExperimental Treatment2 Interventions

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)

Group II: Neurofeedback-active + TMS-shamActive Control2 Interventions

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)

Group III: Check-In OnlyActive Control1 Intervention

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

Group IV: Neurofeedback-sham + TMS-activeActive Control2 Interventions

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)

Group V: Neurofeedback-sham + TMS-shamPlacebo Group2 Interventions

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)