Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology

Not Applicable

Completed

• Conditions: Dystonia-Parkinsonism, Adult-Onset; Parkinson Disease
• Interventions: Device: Boston Scientific Vercise PC IPG with directional DBS lead

• Registration Number: NCT03409120
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-01-13
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-24
• Primary Completion: 2021-06-30
• Results First Submitted: 2022-06-24
• Study Completion: 2022-06-30
• Status Verified: 2022-07
• Results First Submitted QC: 2022-10-17
• Last Update Submitted: 2022-10-17
• Results First Posted: 2022-11-10
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

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Exclusion Criteria

• Not enrolled in "Biomarkers to Guide Directional DBS for Parkinson's Disease" (ClinicalTrials.gov Identifier: NCT03353688)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dystonia Severity Assessment	Boston Scientific Vercise PC IPG with directional DBS lead	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.

Primary Outcome Measures

Name	Time	Method
Burke-Fahn-Marsden Dystonia Rating Scale	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. Higher scores on the scale indicate greater disease severity.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States