Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03409120

Collaborator

Michael J. Fox Foundation for Parkinson's Research (Other)

Enrollment

Location

Arm

53.9

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dystonia-Parkinsonism, Adult-Onset Parkinson Disease	Device: Boston Scientific Vercise PC IPG with directional DBS lead	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

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 baselineTo 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 :

Jan 1, 2018

Actual Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

University of Alabama at Birmingham
Michael J. Fox Foundation for Parkinson's Research

Investigators

Principal Investigator: Harrison C Walker, MD, Associate Professor of Neurology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Harrison Walker, MD, Associate Professor of Neurology, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT03409120

Other Study ID Numbers:

IRB-300001136

First Posted:

Jan 24, 2018

Last Update Posted:

Aug 18, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Harrison Walker, MD, Associate Professor of Neurology, University of Alabama at Birmingham

Dystonia

Parkinson's Disease

Additional relevant MeSH terms:

Parkinson Disease

Dystonia

Dystonic Disorders

Parkinsonian Disorders

Study Results

No Results Posted as of Aug 18, 2021