Trial Outcomes & Findings for Deep Brain Stimulation for Alcohol Use Disorder (NCT NCT05522751)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

4-52 weeks

Results posted on

2025-08-15

Participant Flow

224 potential subjects were prescreened. Most prescreened subjects were not eligible. Around fifteen percent of those who were potentially eligible never followed up or were no longer interested.

3 subjects consented and were enrolled. One subject was a screen-fail and was not implanted with the device.

Participant milestones

Participant milestones
Measure	AUD DBS This is a single arm study. Participants 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 repeat comprehensive assessments.
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	AUD DBS This is a single arm study. Participants 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 repeat comprehensive assessments.
Overall Study Adverse Event	1

Baseline Characteristics

Deep Brain Stimulation for Alcohol Use Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AUD DBS n=2 Participants This is a single arm study. Participants 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 repeat comprehensive assessments.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	2 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	2 Participants n=99 Participants

PRIMARY outcome

Timeframe: 4-52 weeks

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).

Outcome measures

Outcome measures
Measure	AUD DBS n=2 Participants This is a single arm study. Participants 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 repeat comprehensive assessments.
Number of Serious Adverse Events (Safety and Tolerability) Serious Adverse Events	1 Adverse Events
Number of Serious Adverse Events (Safety and Tolerability) Other Adverse Events	1 Adverse Events

PRIMARY outcome

Timeframe: 0-71 weeks

Population: 224 potential participants were pre-screened for recruitment.

This will be evaluated based on number of participants recruited and enrolled in the study between study start date and primary completion date.

Outcome measures

Outcome measures
Measure	AUD DBS n=224 Participants This is a single arm study. Participants 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 repeat comprehensive assessments.
Recruitment (Feasibility)	3 Participants

PRIMARY outcome

Timeframe: 4-52 weeks

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.

Outcome measures

Outcome measures
Measure	AUD DBS n=66 Evaluations This is a single arm study. Participants 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 repeat comprehensive assessments.
Proportion of Completed Assessments (Feasibility)	100 Percent of total assessments Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	AUD DBS n=1 Participants This is a single arm study. Participants 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 repeat comprehensive assessments.
Overall Functioning Baseline	1.61 score on a scale
Overall Functioning 6 months	1.5 score on a scale

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	AUD DBS n=1 Participants This is a single arm study. Participants 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 repeat comprehensive assessments.
Alcohol Use - Percent Days Abstinent Baseline	14.6 percentage of days
Alcohol Use - Percent Days Abstinent 6 months	81 percentage of days

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	AUD DBS n=1 Participants This is a single arm study. Participants 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 repeat comprehensive assessments.
Alcohol Use - Drinks Per Drinking Day Baseline	10.49 drinks per drinking day
Alcohol Use - Drinks Per Drinking Day 6 months	5 drinks per drinking day

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	AUD DBS n=1 Participants This is a single arm study. Participants 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 repeat comprehensive assessments.
Target Engagement Limbic pallidum change in activity at 6 months relative to baseline	-7 percentage of cerebellar activity
Target Engagement Ventral striatum change in activity at 6 months relative to baseline	-13 percentage of cerebellar activity
Target Engagement OFC change in activity at 6 months relative to baseline	-14 percentage of cerebellar activity

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

To measure subjective craving after presentation of alcohol or neutral pictorial cues pre and post DBS. Craving is reported using a visual analog scale (VAS) between 0 and 100, where 100 indicates very high craving; the cue reactivity craving score is calculated as the difference in craving scores after alcohol vs. neutral pictures.

Outcome measures

Outcome measures
Measure	AUD DBS n=1 Participants This is a single arm study. Participants 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 repeat comprehensive assessments.
Cue Reactivity Craving Score Baseline	73.06 score on a scale
Cue Reactivity Craving Score 6 months	-3 score on a scale

Adverse Events

AUD DBS

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	AUD DBS n=2 participants at risk This is a single arm study. Participants 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 repeat comprehensive assessments.
Nervous system disorders Intracranial hemorrhage during surgery	50.0% 1/2 • Number of events 1 • 52 weeks

Other adverse events

Other adverse events
Measure	AUD DBS n=2 participants at risk This is a single arm study. Participants 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 repeat comprehensive assessments.
Musculoskeletal and connective tissue disorders surgical wound pain	50.0% 1/2 • Number of events 1 • 52 weeks

Additional Information

Khaled Moussawi

University of California San Francisco

Phone: 415-502-6343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place