NCT03829761

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

Cerebellar Repetitive Transcranial Magnetic Stimulation (rTMS) for Reduction of Negative Affect and Treatment of Alcohol Use Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: The Mind Research Network · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DEVICE	Repetitive transcranial magnetic stimulation (rTMS)	Repetitive transcranial magnetic stimulation (rTMS). Participants will undergo 10 daily sessions (Mon-Fri) of 30 minutes of 1Hz stimulation, for a total of 1800 pulses delivered.
DEVICE	Sham transcranial magnetic stimulation	Sham transcranial magnetic stimulation (TMS). Participants will undergo 10 daily sessions (Mon-Fri) of 30 minutes of sham stimulation. Sham stimulation will imitate the active rTMS but does not have active stimulation.

Timeline

• Start date: 2019-02-20
• Primary completion: 2023-09-07
• Completion: 2023-09-07
• First posted: 2019-02-04
• Last updated: 2023-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study