Back to resultsUnlocking Dystonia From Parkinson's Disease With Directional DBS Technology
Primary Purpose
Dystonia-Parkinsonism, Adult-Onset, Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Boston Scientific Vercise PC IPG with directional DBS lead
Sponsored by
About this trial
This is an interventional basic science trial for Dystonia-Parkinsonism, Adult-Onset focused on measuring Dystonia, Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- Enrollment in "Biomarkers to Guide Directional DBS for Parkinson's Disease" (ClinicalTrials.gov Identifier: NCT03353688)
- Diagnosis of Parkinson's disease with and without dystonia
Exclusion Criteria:
- Not enrolled in "Biomarkers to Guide Directional DBS for Parkinson's Disease" (ClinicalTrials.gov Identifier: NCT03353688)
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dystonia Severity Assessment
Arm Description
We will measure the effects of DBS on dystonia by assessing changes in the Burke-Fahn-Marsden Dystonia Rating Scale at 2, 4, 6, and 12 months after surgery to implant the Boston Scientific Vercise PC IPG with directional DBS lead versus preoperative baseline.
Outcomes
Primary Outcome Measures
Burke-Fahn-Marsden Dystonia Rating Scale
Evaluation of degree of dystonia related symptoms. Domains evaluated include eyes, mouth, speech/swallowing, neck, arms, trunk, and legs. Each domain is scored on degree of provoking factor (0= no dystonia at rest or with action; 4 = dystonia present at rest) and severity factor (0 = no dystonia; 4 = extreme/severe dystonia). Scores are then weighted yielding a total score between 0 and 120. Higher scores on the scale indicate greater disease severity.
Secondary Outcome Measures
Full Information
NCT ID
NCT03409120
First Posted
January 13, 2018
Last Updated
October 17, 2022
Sponsor
University of Alabama at Birmingham
Collaborators
Michael J. Fox Foundation for Parkinson's Research
1. Study Identification
Unique Protocol Identification Number
NCT03409120
Brief Title
Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology
Official Title
Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Michael J. Fox Foundation for Parkinson's Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study occurs during five visits that are already scheduled as part of "Biomarkers to Guide Directional DBS for Parkinson's Disease" (ClinicalTrials.gov Identifier: NCT03353688). If participants have dystonia associated with Parkinson's disease, the investigators will consent and administer one additional rating scale (Burke-Fahn-Marsden Dystonia Rating Scale) to assess the severity of dystonia.
Detailed Description
To measure the effects of DBS on dystonia, the investigators will measure the change in the Burke-Fahn-Marsden Dystonia Rating Scale at 2, 4, 6, and 12 months after surgery versus preoperative baseline. This will allow them to contrast the effects of omnidirectional versus directional STN DBS on dystonia symptoms in patients with PD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystonia-Parkinsonism, Adult-Onset, Parkinson Disease
Keywords
Dystonia, Parkinson's Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
To measure the effects of directional DBS on dystonia, we will measure the change in the Burke-Fahn-Marsden Dystonia Rating Scale at 2, 4, 6, and 12 months after surgery versus preoperative baseline
Masking
None (Open Label)
Masking Description
This study will run in conjunction with "Biomarkers to Guide Directional DBS for Parkinson's Disease" (ClinicalTrials.gov Identifier: NCT03353688). It is a double blinded study investigating the effectiveness of directional DBS leads in which participants and some investigators will have no knowledge of the DBS settings participants experience.
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dystonia Severity Assessment
Arm Type
Experimental
Arm Description
We will measure the effects of DBS on dystonia by assessing changes in the Burke-Fahn-Marsden Dystonia Rating Scale at 2, 4, 6, and 12 months after surgery to implant the Boston Scientific Vercise PC IPG with directional DBS lead versus preoperative baseline.
Intervention Type
Device
Intervention Name(s)
Boston Scientific Vercise PC IPG with directional DBS lead
Intervention Description
We will contrast the effects of omnidirectional versus directional STN DBS on dystonia symptoms in patients with PD.
Primary Outcome Measure Information:
Title
Burke-Fahn-Marsden Dystonia Rating Scale
Description
Evaluation of degree of dystonia related symptoms. Domains evaluated include eyes, mouth, speech/swallowing, neck, arms, trunk, and legs. Each domain is scored on degree of provoking factor (0= no dystonia at rest or with action; 4 = dystonia present at rest) and severity factor (0 = no dystonia; 4 = extreme/severe dystonia). Scores are then weighted yielding a total score between 0 and 120. Higher scores on the scale indicate greater disease severity.
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Enrollment in "Biomarkers to Guide Directional DBS for Parkinson's Disease" (ClinicalTrials.gov Identifier: NCT03353688)
Diagnosis of Parkinson's disease with and without dystonia
Exclusion Criteria:
Not enrolled in "Biomarkers to Guide Directional DBS for Parkinson's Disease" (ClinicalTrials.gov Identifier: NCT03353688)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harrison C Walker, MD
Organizational Affiliation
Associate Professor of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35702056
Citation
Olson JW, Nakhmani A, Irwin ZT, Edwards LJ, Gonzalez CL, Wade MH, Black SD, Awad MZ, Kuhman DJ, Hurt CP, Guthrie BL, Walker HC. Cortical and Subthalamic Nucleus Spectral Changes During Limb Movements in Parkinson's Disease Patients with and Without Dystonia. Mov Disord. 2022 Aug;37(8):1683-1692. doi: 10.1002/mds.29057. Epub 2022 Jun 14.
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Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology
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