N/A
N=38
Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology
Dystonia-Parkinsonism, Adult-Onset · Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT03409120 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Burke-Fahn-Marsden Dystonia Rating Scale — 3.5 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Boston Scientific Vercise PC IPG with directional DBS lead (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Burke-Fahn-Marsden Dystonia Rating Scale |
3.5 | <0.001 sig |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03409120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.