Trial Outcomes & Findings for Trial Comparing Functional Outcomes of Awake vs. Asleep Deep Brain Stimulation (DBS) for Parkinson's Disease (NCT NCT02401308)
NCT ID: NCT02401308
Last Updated: 2021-10-26
Results Overview
Motor function outcomes using accepted metrics for Parkinson's disease - the Unified Parkinson's Disease Rating Scale \[UPDRS\] obtained in 3 states: 1. medication "off" / device "on". 2. Medication "off" / device "off" 3. medication "on" / device "on"
TERMINATED
NA
1 participants
6 months post-operatively
2021-10-26
Participant Flow
Participant milestones
| Measure |
Awake DBS Surgery
Deep brain stimulation surgery: Parkinson's patients undergoing traditional "awake" DBS surgery utilizing microelectrode recordings and intra-operative stimulation
Deep Brain Stimulation surgery: Deep Brain Stimulation surgery: awake vs. asleep
|
Asleep DBS Surgery
Deep brain stimulation surgery:Parkinson's patients undergoing DBS surgery under general anesthesia utilizing intraoperative imaging to verify the stereotactic accuracy of DBS electrodes placement at the time of surgery.
Deep Brain Stimulation surgery: Deep Brain Stimulation surgery: awake vs. asleep
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Awake DBS Surgery
Deep brain stimulation surgery: Parkinson's patients undergoing traditional "awake" DBS surgery utilizing microelectrode recordings and intra-operative stimulation
Deep Brain Stimulation surgery: Deep Brain Stimulation surgery: awake vs. asleep
|
Asleep DBS Surgery
Deep brain stimulation surgery:Parkinson's patients undergoing DBS surgery under general anesthesia utilizing intraoperative imaging to verify the stereotactic accuracy of DBS electrodes placement at the time of surgery.
Deep Brain Stimulation surgery: Deep Brain Stimulation surgery: awake vs. asleep
|
|---|---|---|
|
Overall Study
Study was terminated by the PI due to lack of enrollment.
|
0
|
1
|
Baseline Characteristics
Trial Comparing Functional Outcomes of Awake vs. Asleep Deep Brain Stimulation (DBS) for Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Awake DBS Surgery
Deep brain stimulation surgery: Parkinson's patients undergoing traditional "awake" DBS surgery utilizing microelectrode recordings and intra-operative stimulation
Deep Brain Stimulation surgery: Deep Brain Stimulation surgery: awake vs. asleep
|
Asleep DBS Surgery
n=1 Participants
Deep brain stimulation surgery:Parkinson's patients undergoing DBS surgery under general anesthesia utilizing intraoperative imaging to verify the stereotactic accuracy of DBS electrodes placement at the time of surgery.
Deep Brain Stimulation surgery: Deep Brain Stimulation surgery: awake vs. asleep
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
—
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post-operativelyPopulation: Study was terminated due to lack of enrollment. No analysis was completed.
Motor function outcomes using accepted metrics for Parkinson's disease - the Unified Parkinson's Disease Rating Scale \[UPDRS\] obtained in 3 states: 1. medication "off" / device "on". 2. Medication "off" / device "off" 3. medication "on" / device "on"
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months post-operativelyPopulation: Study was terminated due to lack of enrollment. No analysis was completed.
Neurocognitive evaluation consisting of the following routine evaluative tests: Wechsler Test of Adult Reading, Mattis Dementia Rating Scale 2nd Edition, Wechsler Abbreviate Scale of Intelligence 2nd Edition; Wechsler Memory Scale 3rd edition, Digit Span, Stroop Neuropsychological Screening Test, Trail Making Test, Wisconsin Card Sorting Test, Controlled Oral Word Association Test, Animal Naming, Boston Naming Test, Wechsler Memory Scale 4th Edition, Logical Memory, Hopkins Verbal Learning Test - Revised, Brief Visuospatial Memory Test - Revised, Hooper visual Organization Test, Judgment of Line Orientation, Beck Depression Inventory, Beck Anxiety Inventory, Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease, Apathy Evaluation Scale; Epworth Sleepiness Scale.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months post-operativelyPopulation: Study was terminated due to lack of enrollment. No analysis was completed.
Parkinson's Disease Questionnaire-39 to evaluate the patient's assessment of their quality of life following DBS surgery
Outcome measures
Outcome data not reported
Adverse Events
Awake DBS Surgery
Asleep DBS Surgery
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lisa Arnold - Operations Manager Neurosurgery Clinical Research
St. Joseph's Hospital and Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place