Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology

Study Overview
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Brief Summary
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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
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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.

Official Title
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Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology

Conditions
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Dystonia-Parkinsonism, Adult-Onset, Parkinson Disease

Intervention / Treatment
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* Device: Boston Scientific Vercise PC IPG with directional DBS lead


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dystonia Severity Assessment<br>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. | Device: Boston Scientific Vercise PC IPG with directional DBS lead<br>* We will contrast the effects of omnidirectional versus directional STN DBS on dystonia symptoms in patients with PD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dystonia, Parkinson's Disease