Clinical Outcomes for Deep Brain Stimulation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Dystonia; Essential Tremor
• Intervention / Treatment: Device: Deep Brain Stimulation

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Mwiza Ushe, M.D.; Phone Number: 3143625262; Email: ushem@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University in St Louis
      • Contact: Mwiza Ushe, M.D.; Phone Number: 314-362-5262; Email: ushem@wustl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients receiving deep brain stimulation for movement disorders

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Investigators: Principal Investigator: Mwiza Ushe, M.D., Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2011
• Primary Completion (Anticipated): January 1, 2030
• Study Completion (Anticipated): January 1, 2030

Study Registration Dates

• First Submitted: June 13, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 20, 2019

Study Record Updates

• Last Update Posted (Actual): June 20, 2019
• Last Update Submitted That Met QC Criteria: June 19, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Deep brain stimulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Parkinson Disease; Dystonia; Dystonic Disorders; Tremor; Essential Tremor
• Other Study ID Numbers: 201101744; R01NS075321 (U.S. NIH Grant/Contract); R01NS097437 (U.S. NIH Grant/Contract); R21NS098020 (U.S. NIH Grant/Contract); T32EB021955 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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