Neurofeedback + TMS for Alcoholism (CNT Trial)

N/A

Waitlist Available

Led By Samantha J Fede, PhD

Research Sponsored by Auburn University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups)

Summary

This trial studies if MRI and TMS can help people with Alcohol Use Disorder. Participants will come in for 4 weeks of intervention and follow-up visits for up to a year.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects from the interventions may include discomfort from the TMS procedure like scalp pain or headache during and after treatment. The fMRI process is generally safe but might cause unease due to loud noises or confinement in the machine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups)

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Aggression and Victimization over Time

Ethanol

Alcohol Use Disorder

+5 more

Secondary study objectives

Brain

Change in Resting State Functional Connectivity over Time

Trial Design

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)

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