Trial Outcomes & Findings for Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder (NCT NCT03950492)
NCT ID: NCT03950492
Last Updated: 2025-07-28
Results Overview
Study participants will be closely monitored for adverse events following DBS surgery with regular check-ups by study personnel.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
Enrollment - 52 weeks
Results posted on
2025-07-28
Participant Flow
Participant milestones
| Measure |
OUD DBS
This is a single arm study. Participants will be followed in an inpatient service for two weeks to gather baseline data followed by DBS placement and up to 6 weeks inpatient for clinical stabilization and DBS titration. All participants will then be followed twice a week for 12 weeks in the outpatient setting and then once a week for a total of 52 weeks post-titration.
Deep Brain Simulator: This is an open-label, safety, tolerability, and feasibility study for participants who have treatment refractory OUD that are eligible to have DBS targeting the NAc/VC.
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|---|---|
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Overall Study
STARTED
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4
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Overall Study
COMPLETED
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2
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder
Baseline characteristics by cohort
| Measure |
OUD DBS
n=4 Participants
This is a single arm study. Participants will be followed in an inpatient service for two weeks to gather baseline data followed by DBS placement and up to 6 weeks inpatient for clinical stabilization and DBS titration. All participants will then be followed twice a week for 12 weeks in the outpatient setting and then once a week for a total of 52 weeks post-titration.
Deep Brain Simulator: This is an open-label, safety, tolerability, and feasibility study for participants who have treatment refractory OUD that are eligible to have DBS targeting the NAc/VC.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
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Sex: Female, Male
Male
|
4 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
|
4 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
|
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Region of Enrollment
United States
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4 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Enrollment - 52 weeksStudy participants will be closely monitored for adverse events following DBS surgery with regular check-ups by study personnel.
Outcome measures
| Measure |
OUD DBS
n=4 Participants
This is a single arm study. Participants will be followed in an inpatient service for two weeks to gather baseline data followed by DBS placement and up to 6 weeks inpatient for clinical stabilization and DBS titration. All participants will then be followed twice a week for 12 weeks in the outpatient setting and then once a week for a total of 52 weeks post-titration.
Deep Brain Simulator: This is an open-label, safety, tolerability, and feasibility study for participants who have treatment refractory OUD that are eligible to have DBS targeting the NAc/VC.
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|---|---|
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Total Number of Study-Emergent Adverse Events
Total Mild AEs
|
74 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Mild AE - Unexpected
|
32 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Mild AE- Expected
|
42 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Mild AE - Possibly Related (Stimulation/Disorder)
|
4 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Mild AE - Possibly Related (Stimulation)
|
1 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Mild AE - Possibly Related (Disorder)
|
1 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Mild AE - Unlikely Related
|
6 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Mild AE - Unrelated
|
27 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Moderate AE - Probably Related (Surgical Procedure)
|
1 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Moderate AE - Probably Related (Stimulation/Disorder)
|
1 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Moderate AE - Probably Related (Disorder)
|
5 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Moderate AE - Possibly Related (Disorder)
|
1 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Moderate AE - Unlikely Related
|
1 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Moderate AE - Unrelated
|
20 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Severe AE - Unlikely Related
|
2 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Severe AE - Possibly Related (Surgical Procedure)
|
1 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Severe AE - Possibly Related (Disorder)
|
2 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Total Moderate AEs
|
29 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Moderate AE - Unexpected
|
20 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Moderate AE - Expected
|
9 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Total Severe AEs
|
5 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Severe AE - Unexpected
|
4 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Severe AE - Expected
|
1 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Mild AE - Definitely Related (Surgical Procedure)
|
1 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Mild AE - Definitely Related (Disorder)
|
1 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Mild AE - Probably Related (Surgical Procedure/Stimulation)
|
1 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Mild AE - Probably Related (Stimulation)
|
2 Adverse Events
|
|
Total Number of Study-Emergent Adverse Events
Mild AE - Probably Related (Disorder)
|
30 Adverse Events
|
PRIMARY outcome
Timeframe: 12 weeksOpioid use as measured by quantitative urine toxicology via high pressure liquid chromatography.
Outcome measures
| Measure |
OUD DBS
n=4 Participants
This is a single arm study. Participants will be followed in an inpatient service for two weeks to gather baseline data followed by DBS placement and up to 6 weeks inpatient for clinical stabilization and DBS titration. All participants will then be followed twice a week for 12 weeks in the outpatient setting and then once a week for a total of 52 weeks post-titration.
Deep Brain Simulator: This is an open-label, safety, tolerability, and feasibility study for participants who have treatment refractory OUD that are eligible to have DBS targeting the NAc/VC.
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|---|---|
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Change in Opioid Use
Number of Participant's Opioid Negative through 12 Week Endpoint
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2 participants
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Change in Opioid Use
Number of Participant's Opioid Positive through 12 Week Endpoint
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2 participants
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SECONDARY outcome
Timeframe: 12 -52 weeksIncidence of drug overdose deaths among the participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 - 52 weeksParticipants' retention in traditional medication assisted treatment (MAT).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 - 52 weeksLaboratory tests and evaluation to discern presentation of infectious disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 and 24 weeks post surgeryParticipants will complete standardized measures of mood, drug craving, and executive function at 12 weeks and 24 weeks post DBS titration.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 weeks and 12 weeks post surgery18fluoro-Deoxy-Glucose (FDG) PET will be use to determine if there is an increase in frontal lobe metabolism following DBS
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 weeks and 12 weeks post surgeryC11 Raclopride PET may be used to examine for changes in dopamine at 12 weeks post titration.
Outcome measures
Outcome data not reported
Adverse Events
OUD DBS
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OUD DBS
n=4 participants at risk
This is a single arm study. Participants will be followed in an inpatient service for two weeks to gather baseline data followed by DBS placement and up to 6 weeks inpatient for clinical stabilization and DBS titration. All participants will then be followed twice a week for 12 weeks in the outpatient setting and then once a week for a total of 52 weeks post-titration.
Deep Brain Stimulator: This is an open-label, safety, tolerability, and feasibility study for participants who have treatment refractory OUD that are eligible to have DBS targeting the NAc/VC.
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|---|---|
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Psychiatric disorders
Relapse of Opioid Use
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Psychiatric disorders
Blacked Out
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
Other adverse events
| Measure |
OUD DBS
n=4 participants at risk
This is a single arm study. Participants will be followed in an inpatient service for two weeks to gather baseline data followed by DBS placement and up to 6 weeks inpatient for clinical stabilization and DBS titration. All participants will then be followed twice a week for 12 weeks in the outpatient setting and then once a week for a total of 52 weeks post-titration.
Deep Brain Stimulator: This is an open-label, safety, tolerability, and feasibility study for participants who have treatment refractory OUD that are eligible to have DBS targeting the NAc/VC.
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|---|---|
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Blood and lymphatic system disorders
Abnormal TEG
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Blood and lymphatic system disorders
Activated Partial Thromboplastin Time Prolonged
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Blood and lymphatic system disorders
Lymphocyte Count Decreased
|
25.0%
1/4 • Number of events 2 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Cardiac disorders
Hypotension
|
25.0%
1/4 • Number of events 4 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Cardiac disorders
Palpitations
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Gastrointestinal disorders
GI Disorders, Other - Decreased Appetite
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 5 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Gastrointestinal disorders
Sick feeling
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • Number of events 2 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
General disorders
Acute pharyngitis (sore throat)
|
25.0%
1/4 • Number of events 2 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
General disorders
Chills
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
General disorders
Dysgeusia
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 10 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
General disorders
Headache
|
50.0%
2/4 • Number of events 7 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
General disorders
Insomnia
|
75.0%
3/4 • Number of events 5 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
General disorders
Lethargy
|
25.0%
1/4 • Number of events 3 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
General disorders
Malaise
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
General disorders
Motor vehicle accident
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
General disorders
Nasal Congestion
|
25.0%
1/4 • Number of events 2 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
General disorders
Pharyngitis
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
General disorders
Restlessness
|
25.0%
1/4 • Number of events 5 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
General disorders
Sweats
|
25.0%
1/4 • Number of events 3 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
General disorders
Tremor
|
25.0%
1/4 • Number of events 2 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
General disorders
Twitching left eye brow
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Infections and infestations
COVID-19
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Metabolism and nutrition disorders
Weight Gain
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
75.0%
3/4 • Number of events 5 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Musculoskeletal and connective tissue disorders
Dental pain
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Musculoskeletal and connective tissue disorders
Mouth pain
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Musculoskeletal and connective tissue disorders
Myalgias
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Musculoskeletal and connective tissue disorders
Oral Pain
|
25.0%
1/4 • Number of events 2 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Musculoskeletal and connective tissue disorders
Pain- Shoulder
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Musculoskeletal and connective tissue disorders
Sprain, left ankle
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Musculoskeletal and connective tissue disorders
Tooth Ache
|
25.0%
1/4 • Number of events 2 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Musculoskeletal and connective tissue disorders
Toothache
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Nervous system disorders
Chronic Migraine
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Nervous system disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Nervous system disorders
Hypoxia
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Psychiatric disorders
Agitation
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Psychiatric disorders
Auditory Hallucinations
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Psychiatric disorders
Blacked out
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Psychiatric disorders
Depression
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Psychiatric disorders
Overuse-no adverse effect-Suboxone misuse
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Psychiatric disorders
Relapse
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Psychiatric disorders
Sleep Disturbance (Nightmares)
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Psychiatric disorders
Sleep Disturbances, Nightmares
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Renal and urinary disorders
Bacteria Urine
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Renal and urinary disorders
Dysuria
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Renal and urinary disorders
Renal Calculi
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • Number of events 2 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Skin and subcutaneous tissue disorders
Abrasion, right wrist
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Skin and subcutaneous tissue disorders
Bilateral Foot Pruritis
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Skin and subcutaneous tissue disorders
Bruising (arm)
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Skin and subcutaneous tissue disorders
Burn
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Skin and subcutaneous tissue disorders
Contact Dermatitis
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Skin and subcutaneous tissue disorders
Infusion Site Irritation
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Skin and subcutaneous tissue disorders
Injury, Other - Physical Altercation with bruising, edema, pain
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Skin and subcutaneous tissue disorders
Laceration (chin)
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Skin and subcutaneous tissue disorders
Papular urticaria - bug bites left ankle
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Skin and subcutaneous tissue disorders
Parasthesia, left ear
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Skin and subcutaneous tissue disorders
Paresthesia - Hand
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Skin and subcutaneous tissue disorders
Penile rash
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Skin and subcutaneous tissue disorders
Poison Ivy
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Skin and subcutaneous tissue disorders
Rash Macro-Papular
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Skin and subcutaneous tissue disorders
Rash, facial
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Skin and subcutaneous tissue disorders
Rectal pain
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Skin and subcutaneous tissue disorders
Wound - insect bite right leg
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
|
Blood and lymphatic system disorders
Incarceration
|
25.0%
1/4 • Number of events 1 • 52 weeks
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs: Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
|
Additional Information
James Mahoney, PhD
WVU Rockefeller Neuroscience Institute
Phone: 304-293-5323
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place