Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease (INTREPID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01839396
Recruitment Status : Active, not recruiting
First Posted : April 24, 2013
Results First Posted : August 15, 2018
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Parkinson's Disease
Intervention Device: Deep Brain Stimulation
Enrollment 313
Recruitment Details 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
Pre-assignment Details 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
Arm/Group Title Medium Continuous Dose of Stimulation Low Intermittent Dose of Stimulation
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 121 39
Completed 121 39
Not Completed 0 0
Arm/Group Title Medium Continuous Dose of Stimulation Low Intermittent Dose of Stimulation Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 121 39 160
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 121 participants 39 participants 160 participants
60.7  (7.9) 57.5  (7.66) 59.9  (7.9)
[1]
Measure Description: Mean age is reported at time of enrollment
[2]
Measure Analysis Population Description: Information for each group and overall population is provided.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 39 participants 160 participants
Female
31
  25.6%
13
  33.3%
44
  27.5%
Male
90
  74.4%
26
  66.7%
116
  72.5%
1.Primary Outcome
Title Change in ON Time as Measured by Parkinson's Disease Diary
Hide Description 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
Time Frame From baseline to 12 weeks post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medium Continuous Dose of Stimulation Low Intermittent Dose of Stimulation
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 118 38
Mean (Standard Deviation)
Unit of Measure: hours
3.74  (4.79) 0.72  (3.56)
2.Secondary Outcome
Title Secondary Endpoints
Hide Description

Change 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.

Time Frame From baseline to 12 weeks post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medium Continuous Dose of Stimulation Low Intermittent Dose of Stimulation
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 115 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.02  (11.4) 1.19  (8.9)
Time Frame Adverse event data was collected up to 12 weeks and up to Dec 2016.
Adverse Event Reporting Description Serious Adverse Events related to hardware, stimulation or procedure are reported
 
Arm/Group Title Medium Continuous Dose of Stimulation Low Intermittent Dose of Stimulation
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Medium Continuous Dose of Stimulation Low Intermittent Dose of Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/121 (0.00%)      0/39 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Medium Continuous Dose of Stimulation Low Intermittent Dose of Stimulation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/121 (11.57%)      4/39 (10.26%)    
Cardiac disorders     
Myocardial Infarction  1  1/121 (0.83%)  1 0/39 (0.00%)  0
General disorders     
Implant Site Edema  1  0/121 (0.00%)  0 1/39 (2.56%)  1
Pyrexia  1  1/121 (0.83%)  1 0/39 (0.00%)  0
Infections and infestations     
Device related Infection  1  3/121 (2.48%)  3 0/39 (0.00%)  0
Implant Site Infection  1  1/121 (0.83%)  1 0/39 (0.00%)  0
Staphylococcal Skin infection  1  0/121 (0.00%)  0 1/39 (2.56%)  1
Injury, poisoning and procedural complications     
Wound Heamorhage  1  1/121 (0.83%)  1 0/39 (0.00%)  0
Nervous system disorders     
Aphasia  1  1/121 (0.83%)  1 0/39 (0.00%)  0
Intracranial hypotension  1  0/121 (0.00%)  0 1/39 (2.56%)  1
Pneumocephalus  1  1/121 (0.83%)  1 0/39 (0.00%)  0
Psychiatric disorders     
Confusional postoperative  1  2/121 (1.65%)  2 0/39 (0.00%)  0
Confusional state  1  1/121 (0.83%)  1 0/39 (0.00%)  0
Convulsion  1  1/121 (0.83%)  1 1/39 (2.56%)  1
Respiratory, thoracic and mediastinal disorders     
Hypoventilation  1  1/121 (0.83%)  1 0/39 (0.00%)  0
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Medium Continuous Dose of Stimulation Low Intermittent Dose of Stimulation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/121 (28.93%)      4/39 (10.26%)    
General disorders     
Implant Site Edema  1  7/121 (5.79%)  8 3/39 (7.69%)  3
Nervous system disorders     
Balance Disorder  1  7/121 (5.79%)  7 0/39 (0.00%)  0
Dyskinesia  1  21/121 (17.36%)  23 1/39 (2.56%)  1
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Clinical Study Agreement that restricts the PIs until official study manuscript is published.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roshini Jain, Director of Clinical Sciences
Organization: Boston Scientific
Phone: 6619494355
EMail: roshini.jain@bsci.com
Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01839396     History of Changes
Other Study ID Numbers: G120075
CDM00049710/90876693 ( Other Identifier: BSC protocol number )
First Submitted: April 22, 2013
First Posted: April 24, 2013
Results First Submitted: February 16, 2018
Results First Posted: August 15, 2018
Last Update Posted: September 10, 2019