Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-10 @ 8:11 PM
Study NCT ID:
NCT05522751
Status:
COMPLETED
Last Update Posted:
2025-08-15
First Post:
2022-08-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Deep Brain Stimulation for Alcohol Use Disorder
Sponsor:
Khaled Moussawi
Organization:
Study Overview
Official Title:
Limbic Pallidum Deep Brain Stimulation for the Treatment of Severe Alcohol Use Disorder
Status:
COMPLETED
Status Verified Date:
2025-08
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 purpose of this clinical study is to investigate the safety, tolerability, and feasibility of Deep Brain Stimulation (DBS) of the limbic pallidum in participants with severe alcohol use disorder (AUD) who have advanced but compensated liver fibrosis.
Detailed Description:
Participants with severe AUD will undergo baseline medical and psychiatric assessments, cognitive and behavioral testing, and positron emission tomography (PET) imaging. One to two weeks later, participants will undergo neurosurgical implantation of DBS electrodes in the limbic pallidum and a neurostimulator. Four weeks after DBS system implantation, the DBS system will be turned ON and the stimulation parameters optimized. Participants will be followed biweekly then monthly for repeated comprehensive assessments.
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?:
None
Is an FDA AA801 Violation?: