Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology

NCT03409120 | Completed Results DMC FDA Device

• 1 other identifier: IRB-300001136
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Dystonia-Parkinsonism, Adult-Onset; Parkinson Disease

Keywords

Dystonia; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Burke-Fahn-Marsden Dystonia Rating Scale

  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.

  5 minutes

Study Arms (1)

Dystonia Severity Assessment

EXPERIMENTAL

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

Interventions

Boston Scientific Vercise PC IPG with directional DBS lead DEVICE

We will contrast the effects of omnidirectional versus directional STN DBS on dystonia symptoms in patients with PD.

Dystonia Severity Assessment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrollment in "Biomarkers to Guide Directional DBS for Parkinson's Disease" (ClinicalTrials.gov Identifier: NCT03353688)
• Diagnosis of Parkinson's disease with and without dystonia

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Olson JW, Nakhmani A, Irwin ZT, Edwards LJ, Gonzalez CL, Wade MH, Black SD, Awad MZ, Kuhman DJ, Hurt CP, Guthrie BL, Walker HC. Cortical and Subthalamic Nucleus Spectral Changes During Limb Movements in Parkinson's Disease Patients with and Without Dystonia. Mov Disord. 2022 Aug;37(8):1683-1692. doi: 10.1002/mds.29057. Epub 2022 Jun 14.

  PMID: 35702056 BACKGROUND

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Time and physical constraints during surgery sometimes limit data collection, and acute implant of the DBS lead introduces microlesion effects that could alter electrophysiology.

Results Point of Contact

• Title: Christopher Gonzalez
• Organization: University of Alabama at Birmingham

clg17@uab.edu

2059753732

Study Officials

• Harrison C Walker, MD

  Associate Professor of Neurology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Model Details: 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

Study Record Dates

• First Submitted: January 13, 2018
• First Posted: January 24, 2018
• Study Start: January 1, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2022
• Last Updated: November 10, 2022
• Results First Posted: November 10, 2022

Record last verified: 2022-07

Locations

US (1)