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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03992625
Other study ID # 201101744
Secondary ID R01NS075321R01NS
Status Recruiting
Phase
First received
Last updated
Start date January 3, 2011
Est. completion date January 1, 2030

Study information

Verified date June 2019
Source Washington University School of Medicine
Contact Mwiza Ushe, M.D.
Phone 3143625262
Email ushem@wustl.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date January 1, 2030
Est. primary completion date January 1, 2030
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Intervention

Device:
Deep Brain Stimulation
High frequency electrical stimulation of deep brain nuclei for the treatment of movement disorders

Locations

Country Name City State
United States Washington University in St Louis Saint Louis Missouri

Sponsors (3)

Lead Sponsor Collaborator
Washington University School of Medicine National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary UPDRS 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. Change in UPDRS at 1 year after DBS (from preoperative baseline).
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