Cerebellar Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Alcohol Use Disorder

The Mind Research Network

Status

Completed

Conditions

Alcohol Use Disorder

Treatments

Device: Sham transcranial magnetic stimulation

Device: Repetitive transcranial magnetic stimulation (rTMS)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03829761

14918 (Other Identifier)

R21AA026573 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The objective of the current study is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) on self-reported negative affect, cerebellar brain activation and alcohol use outcomes in alcohol use disorder (AUD).

Full description

To achieve study aims, 34 treatment seeking adults with AUD will be recruited from local intensive outpatient (IOP) treatment programs and randomized to treatment with either inhibitory 1Hz rTMS to cerebellar vermis given daily for 2 weeks (total of 10 sessions) or sham. Alcohol use outcomes, self-reported negative affect, and craving will be obtained at baseline, 1 day, 1 week and 6 weeks following rTMS termination. An fMRI scan during a Stroop task will be obtained at baseline and 1 day after the final rTMS session.

Enrollment

24 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males and females age 18-65 meeting DSM-V criteria for moderate or severe AUD in the past year;
Interested in cutting down or quitting drinking;
Able to provide voluntary informed consent;
Have at least 4 heavy drinking days (≥ 5 drinks per day for men, and ≥4 for women) in the past 60 days;
Currently receiving treatment for alcohol use disorder.

Exclusion criteria

Severe neurological conditions (TBI/stroke/history of a seizure/dementia and other significant cognitive illnesses);
Other urgent medical problems, as determined by the study physician from the history and physical exam;
Schizophrenia, schizoaffective disorder, bipolar I disorder
Suicidal thoughts (intent or plan) in the last month;
Current moderate or severe other SUD (except nicotine or marijuana) or other drug (except nicotine or marijuana) use in the past month;
Active legal problems with the potential to result in incarceration;
Pregnancy or lactation, or child bearing age and sexually active but not on birth control (barrier methods allowed);
Current daily use of anti-craving medications, antidepressants (at doses considered therapeutic for depression), benzodiazepines, antipsychotics (at doses considered therapeutic for psychosis or mood stabilization), mood stabilizers (at doses considered therapeutic for mood stabilization);
Have previously undergone rTMS (to assure the blind is effective);
Personal or familial (in first degree relatives) history of epilepsy;
Any contraindication for Magnetic Resonance Imaging (MRI) or TMS including metal shards or certain implants (pacemakers etc.) in the body.