Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology

Parkinson Disease Clinical Trial

Official title:

Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03409120
• Other study ID #: IRB-300001136
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dystonia
• Dystonia-Parkinsonism, Adult-Onset
• Dystonic Disorders
• Parkinson Disease
• Parkinsonian Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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