Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-27 @ 4:06 PM
Study NCT ID:
NCT03829761
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2018-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebellar Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Alcohol Use Disorder
Sponsor:
The Mind Research Network
Organization:
Study Overview
Official Title:
Cerebellar Repetitive Transcranial Magnetic Stimulation (rTMS) for Reduction of Negative Affect and Treatment of Alcohol Use Disorder
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R21AA026573 | NIH | None | https://reporter.nih.gov/quic… | View |