Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology

The University of Alabama at Birmingham

Status: Completed

Conditions: Dystonia-Parkinsonism, Adult-Onset; Parkinson Disease

Treatments: Device: Boston Scientific Vercise PC IPG with directional DBS lead

Study type: Interventional

Funder types: Other

Identifiers

NCT03409120

IRB-300001136

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Dystonia Severity Assessment

Experimental group

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.

Treatment:

Device: Boston Scientific Vercise PC IPG with directional DBS lead