Back to resultsStudy to Characterize Acute and Chronic Directional Aspects of Deep Brain Stimulation (DIRECT-DBS)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
BSC Deep Brain Stimulation System with Directional Lead
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease focused on measuring parkinson disease, deep brain stimulation, directional stimulation
Eligibility Criteria
Key Inclusion Criteria:
- Diagnosis of bilateral idiopathic PD with the presence of rigidity and at least one (1) of the following: resting tremor or bradykinesia.
- UPDRS III score of >25 in the meds OFF condition
- Medication must improve PD symptoms by ≥30%, as measured by UPDRS subset III score
Key Exclusion Criteria:
- Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator
- Any current drug or alcohol abuse as determined by the investigator
- Any history of recurrent or unprovoked seizures
- Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months
Sites / Locations
- CHU Grenoble - Hopital Michallon
- Universitaetsklinikum Wuerzburg
- Academisch Medisch Centrum
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ring mode followed by Unrestricted mode
Unrestricted mode followed by ring mode
Arm Description
omni-directional stimulation followed by unrestricted Mode stimulation
Unrestricted Mode stimulation followed by omni-directional stimulation
Outcomes
Primary Outcome Measures
Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase
Mean change in Unified Parkinson's Disease Rating Scale (UPDRS) scores - motor section (Part III) at end of randomized phase in meds ON condition
Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state
Secondary Outcome Measures
Full Information
NCT ID
NCT02835274
First Posted
June 24, 2016
Last Updated
November 17, 2020
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02835274
Brief Title
Study to Characterize Acute and Chronic Directional Aspects of Deep Brain Stimulation
Acronym
DIRECT-DBS
Official Title
Directional Lead: Investigation of Rotational Current Steering, Ease of Use of Clinical Effects Map, and Therapeutic Outcomes of Deep Brain Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 19, 2016 (Actual)
Primary Completion Date
December 19, 2018 (Actual)
Study Completion Date
December 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective is to characterize the programming effects of Boston Scientific Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of Parkinson's disease in acute and chronic settings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
parkinson disease, deep brain stimulation, directional stimulation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ring mode followed by Unrestricted mode
Arm Type
Experimental
Arm Description
omni-directional stimulation followed by unrestricted Mode stimulation
Arm Title
Unrestricted mode followed by ring mode
Arm Type
Active Comparator
Arm Description
Unrestricted Mode stimulation followed by omni-directional stimulation
Intervention Type
Device
Intervention Name(s)
BSC Deep Brain Stimulation System with Directional Lead
Primary Outcome Measure Information:
Title
Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase
Description
Mean change in Unified Parkinson's Disease Rating Scale (UPDRS) scores - motor section (Part III) at end of randomized phase in meds ON condition
Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state
Time Frame
Up to 12 months post-implant
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Diagnosis of bilateral idiopathic PD with the presence of rigidity and at least one (1) of the following: resting tremor or bradykinesia.
UPDRS III score of >25 in the meds OFF condition
Medication must improve PD symptoms by ≥30%, as measured by UPDRS subset III score
Key Exclusion Criteria:
Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator
Any current drug or alcohol abuse as determined by the investigator
Any history of recurrent or unprovoked seizures
Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roshini Jain
Organizational Affiliation
Boston Scientific Neuromodulation Corporation
Official's Role
Study Director
Facility Information:
Facility Name
CHU Grenoble - Hopital Michallon
City
Grenoble
Country
France
Facility Name
Universitaetsklinikum Wuerzburg
City
Wuerzburg
Country
Germany
Facility Name
Academisch Medisch Centrum
City
Amsterdam
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Study to Characterize Acute and Chronic Directional Aspects of Deep Brain Stimulation
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