Clinical Outcomes for Deep Brain Stimulation for Parkinson Disease, Tremor, and Dystonia

Washington University School of Medicine1 site in 1 country1,000 target enrollmentJanuary 3, 2011

ConditionsParkinson Disease Essential Tremor Dystonia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Parkinson Disease
Sponsor: Washington University School of Medicine
Enrollment: 1000
Locations: 1
Primary Endpoint: UPDRS
Status: Recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 3, 2011

End Date

January 1, 2030

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Washington University School of Medicine

Responsible Party

Principal Investigator

Mwiza Ushe

Assistant Professor

Washington University School of Medicine

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

UPDRS

Time Frame: 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.