Trial Outcomes & Findings for Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease (NCT NCT01839396)
NCT ID: NCT01839396
Last Updated: 2023-07-13
Results Overview
Difference in the mean change from baseline to 12 weeks post-randomization between the active and control groups in the ON time as measured by Parkinson's diary. Positive indicates improvement
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
313 participants
Primary outcome timeframe
From baseline to 12 weeks post-randomization
Results posted on
2023-07-13
Participant Flow
Subjects were considered enrolled once informed consent was completed. Only those who met all eligibility criteria went on to receive implant and randomization for study endpoints
Subjects were considered enrolled once informed consent was completed. Only those who met all eligibility criteria went on to receive implant and randomization for study endpoints
Participant milestones
| Measure |
Medium Continuous Dose of Stimulation
Subjects in this arm received a medium continuous dose of Deep Brain stimulation that may have been effective in previous DBS patients.
Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period.
|
Low Intermittent Dose of Stimulation
Subjects in this arm received a lower intermittent dose of Deep Brain stimulation which was less likely to be effective.
Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period.
|
|---|---|---|
|
Overall Study
STARTED
|
121
|
39
|
|
Overall Study
COMPLETED
|
121
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Information for each group and overall population is provided.
Baseline characteristics by cohort
| Measure |
Medium Continuous Dose of Stimulation
n=121 Participants
Subjects in this arm received a medium continuous dose of Deep Brain stimulation that may have been effective in previous DBS patients.
Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period.
|
Low Intermittent Dose of Stimulation
n=39 Participants
Subjects in this arm received a lower intermittent dose of Deep Brain stimulation which was less likely to be effective.
Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
60.7 years
STANDARD_DEVIATION 7.9 • n=93 Participants • Information for each group and overall population is provided.
|
57.5 years
STANDARD_DEVIATION 7.66 • n=4 Participants • Information for each group and overall population is provided.
|
59.9 years
STANDARD_DEVIATION 7.9 • n=27 Participants • Information for each group and overall population is provided.
|
|
Sex: Female, Male
Female
|
31 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
116 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From baseline to 12 weeks post-randomizationDifference in the mean change from baseline to 12 weeks post-randomization between the active and control groups in the ON time as measured by Parkinson's diary. Positive indicates improvement
Outcome measures
| Measure |
Medium Continuous Dose of Stimulation
n=118 Participants
Subjects in this arm received a medium continuous dose of Deep Brain stimulation that may have been effective in previous DBS patients.
Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters were varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period.
|
Low Intermittent Dose of Stimulation
n=38 Participants
Subjects in this arm received a lower intermittent dose of Deep Brain stimulation which was less likely to be effective.
Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters were varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period.
|
|---|---|---|
|
Change in ON Time as Measured by Parkinson's Disease Diary
|
3.74 hours
Standard Deviation 4.79
|
0.72 hours
Standard Deviation 3.56
|
SECONDARY outcome
Timeframe: From baseline to 12 weeks post-randomizationChange in Unified Parkinson's Disease Rating Scale (UDPRS) Part III (stim on/meds off) from baseline to 12 weeks post randomization. Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state.
Outcome measures
| Measure |
Medium Continuous Dose of Stimulation
n=115 Participants
Subjects in this arm received a medium continuous dose of Deep Brain stimulation that may have been effective in previous DBS patients.
Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters were varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period.
|
Low Intermittent Dose of Stimulation
n=37 Participants
Subjects in this arm received a lower intermittent dose of Deep Brain stimulation which was less likely to be effective.
Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters were varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period.
|
|---|---|---|
|
Secondary Endpoints
|
12.02 units on a scale
Standard Deviation 11.4
|
1.19 units on a scale
Standard Deviation 8.9
|
Adverse Events
Medium Continuous Dose of Stimulation
Serious events: 14 serious events
Other events: 35 other events
Deaths: 0 deaths
Low Intermittent Dose of Stimulation
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Medium Continuous Dose of Stimulation
n=121 participants at risk
Subjects in this arm received a medium continuous dose of Deep Brain stimulation that may have been effective in previous DBS patients.
Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters were varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period.
|
Low Intermittent Dose of Stimulation
n=39 participants at risk
Subjects in this arm received a lower intermittent dose of Deep Brain stimulation which was less likely to be effective.
Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters were varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period.
|
|---|---|---|
|
Nervous system disorders
Aphasia
|
0.83%
1/121 • Number of events 1 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
0.00%
0/39 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
|
Psychiatric disorders
Confusional postoperative
|
1.7%
2/121 • Number of events 2 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
0.00%
0/39 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
|
Psychiatric disorders
Confusional state
|
0.83%
1/121 • Number of events 1 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
0.00%
0/39 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
|
Psychiatric disorders
Convulsion
|
0.83%
1/121 • Number of events 1 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
2.6%
1/39 • Number of events 1 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
|
Infections and infestations
Device related Infection
|
2.5%
3/121 • Number of events 3 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
0.00%
0/39 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.83%
1/121 • Number of events 1 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
0.00%
0/39 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
|
General disorders
Implant Site Edema
|
0.00%
0/121 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
2.6%
1/39 • Number of events 1 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
|
Infections and infestations
Implant Site Infection
|
0.83%
1/121 • Number of events 1 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
0.00%
0/39 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
|
Nervous system disorders
Intracranial hypotension
|
0.00%
0/121 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
2.6%
1/39 • Number of events 1 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
|
Cardiac disorders
Myocardial Infarction
|
0.83%
1/121 • Number of events 1 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
0.00%
0/39 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
|
Nervous system disorders
Pneumocephalus
|
0.83%
1/121 • Number of events 1 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
0.00%
0/39 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
|
General disorders
Pyrexia
|
0.83%
1/121 • Number of events 1 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
0.00%
0/39 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
|
Infections and infestations
Staphylococcal Skin infection
|
0.00%
0/121 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
2.6%
1/39 • Number of events 1 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
|
Injury, poisoning and procedural complications
Wound Heamorhage
|
0.83%
1/121 • Number of events 1 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
0.00%
0/39 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
Other adverse events
| Measure |
Medium Continuous Dose of Stimulation
n=121 participants at risk
Subjects in this arm received a medium continuous dose of Deep Brain stimulation that may have been effective in previous DBS patients.
Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters were varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period.
|
Low Intermittent Dose of Stimulation
n=39 participants at risk
Subjects in this arm received a lower intermittent dose of Deep Brain stimulation which was less likely to be effective.
Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters were varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period.
|
|---|---|---|
|
Nervous system disorders
Balance Disorder
|
5.8%
7/121 • Number of events 7 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
0.00%
0/39 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
|
Nervous system disorders
Dyskinesia
|
17.4%
21/121 • Number of events 23 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
2.6%
1/39 • Number of events 1 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
|
General disorders
Implant Site Edema
|
5.8%
7/121 • Number of events 8 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
7.7%
3/39 • Number of events 3 • Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
|
Additional Information
Roshini Jain, Director of Clinical Sciences
Boston Scientific
Phone: 6619494355
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Study Agreement that restricts the PIs until official study manuscript is published.
- Publication restrictions are in place
Restriction type: OTHER