NCT05522751

Deep Brain Stimulation for Alcohol Use Disorder

Limbic Pallidum Deep Brain Stimulation for the Treatment of Severe Alcohol Use Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Khaled Moussawi · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DEVICE	DBS	Bilateral DBS electrodes will be implanted into the limbic pallidum of participants with severe alcohol use disorder and advanced but compensated liver disease.

Timeline

• Start date: 2023-01-10
• Primary completion: 2024-05-20
• Completion: 2024-05-20
• First posted: 2022-08-31
• Last updated: 2025-08-15
• Results posted: 2025-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study