Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology
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|ClinicalTrials.gov Identifier: NCT03409120|
Recruitment Status : Enrolling by invitation
First Posted : January 24, 2018
Last Update Posted : April 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Dystonia-Parkinsonism, Adult-Onset Parkinson Disease||Device: Boston Scientific Vercise PC IPG with directional DBS lead||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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.|
|Primary Purpose:||Basic Science|
|Official Title:||Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Dystonia Severity Assessment
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
We will contrast the effects of omnidirectional versus directional STN DBS on dystonia symptoms in patients with PD.
- Burke-Fahn-Marsden Dystonia Rating Scale [ Time Frame: 5 minutes ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409120
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Harrison C Walker, MD||Associate Professor of Neurology|