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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Bilateral DBS electrodes will be implanted into the limbic pallidum of participants with severe alcohol use disorder and advanced but compensated liver disease.
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Number of Serious Adverse Events (Safety and Tolerability)
This will be evaluated based on number and seriousness of adverse events associated with DBS implantation and stimulation (e.g., infection, bleeding, cognitive or behavioral side effects).
Time frame: 4-52 weeks
Recruitment (Feasibility)
This will be evaluated based on number of participants recruited and enrolled in the study between study start date and primary completion date.
Time frame: 0-71 weeks
Proportion of Completed Assessments (Feasibility)
This will be evaluated based on the average percentage of evaluations completed across participants during the study duration out of total required assessments to measure the participants' adherence to the study protocol.
Time frame: 4-52 weeks
Overall Functioning
Overall function and disability will be measured using standardized questionnaire World Health Organization Disability Assessment 2.0 (WHODAS2.0) score before and after DBS activation (raw score 0-180, higher is worse). The focus of analysis was limited to the 6-month timepoint.
Time frame: 6 months
Alcohol Use - Percent Days Abstinent
assessment of alcohol use will be measured through percent days abstinent (PDA) at baseline (pver preceding 6 months) and at 6 months after DBS activation. PDA at baseline is assessed over the preceding 180 days. PDA at 6 months post-DBS activation is assessed over the preceding 30 days.
Time frame: 6 months
Alcohol Use - Drinks Per Drinking Day
assessment of alcohol use will be measured through drinks per drinking day (DDD) before and after DBS activation. The focus of analysis was limited to the 6-month timepoint. DDD at baseline is assessed over the preceding 180 days. DDD at 6 months post-DBS activation is assessed over the preceding 30 days.
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Time frame: 6 months
Target Engagement
This will be assessed by measuring the percent change in brain metabolism with 18fluoro-Deoxy-Glucose (FDG) PET scans before and after DBS activation. The timepoint 4 weeks post-surgery was excluded because breath alcohol test was positive on that day.
Time frame: 6 months