Clinical Outcomes for Deep Brain Stimulation

Recruiting

• Conditions: Dystonia; Essential Tremor; Parkinson Disease

• Registration Number: NCT03992625
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The object of this study is to longitudinally collect clinical outcomes of patients receiving deep brain stimulation for movement disorders with the objective of making retrospective comparisons and tracking of risks, benefits, and complications.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01-03
• Status Verified: 2019-06
• Study First Submitted: 2019-06-13
• Study First Submitted QC: 2019-06-19
• Last Update Submitted: 2019-06-19
• Study First Posted: 2019-06-20
• Last Update Posted: 2019-06-20
• Primary Completion: 2030-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Levodopa responsive Parkinson disease OR
• Medically refractory Essential Tremor OR
• Medically refractory Dystonia

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Exclusion Criteria

• Dementia (Mattis Dementia Rating Scale <130)
• Structural abnormalities precluding intracranial surgery

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
UPDRS	Change in UPDRS at 1 year after DBS (from preoperative baseline).	United Parkinson's Disease Rating Scale (global assessment of motor, non-motor, and quality of life associated with symptoms of Parkinson disease). Total scores range from 0-199. Particular emphasis is paid to subsection 3 (motor), where scores range from 0-56.

Trial Locations

Locations (1)

Washington University in St Louis; 🇺🇸 Saint Louis, Missouri, United States