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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 : February 7, 2019
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Harrison Walker, MD, 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.

Condition or disease Intervention/treatment Phase
Dystonia-Parkinsonism, Adult-Onset Parkinson Disease Device: Boston Scientific Vercise PC IPG with directional DBS lead Not Applicable

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 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


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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Locations
United States, Alabama
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

Responsible Party: Harrison Walker, MD, Associate Professor of Neurology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03409120     History of Changes
Other Study ID Numbers: IRB-300001136
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Harrison Walker, MD, University of Alabama at Birmingham:
Dystonia
Parkinson's Disease

Additional relevant MeSH terms:
Parkinson Disease
Dystonia
Dystonic Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms