Clinical Outcomes for Deep Brain Stimulation

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03992625
• Other study ID #: 201101744
• Secondary ID: R01NS075321R01NS
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Essential Tremor
• Parkinson Disease
• Tremor

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).