Clinical Outcomes for Deep Brain Stimulation
Sponsor
Washington University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT03992625
Collaborator
National Institute for Biomedical Imaging and Bioengineering (NIBIB) (NIH), National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
1,000
1
227.9
4.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
1000 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Clinical Outcomes for Deep Brain Stimulation for Parkinson Disease, Tremor, and Dystonia
Actual Study Start Date
:
Jan 3, 2011
Anticipated Primary Completion Date
:
Jan 1, 2030
Anticipated Study Completion Date
:
Jan 1, 2030
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University in St Louis | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
- Principal Investigator: Mwiza Ushe, M.D., Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mwiza Ushe,
Assistant Professor,
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT03992625
Other Study ID Numbers:
- 201101744
- R01NS075321
- R01NS097437
- R21NS098020
- T32EB021955
First Posted:
Jun 20, 2019
Last Update Posted:
Jun 20, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Mwiza Ushe,
Assistant Professor,
Washington University School of Medicine
Additional relevant MeSH terms: