Clinical Outcomes for Deep Brain Stimulation

NCT ID: NCT03992625

Last Updated: 2019-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-03

Study Completion Date

2030-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease Essential Tremor Dystonia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Deep Brain Stimulation

High frequency electrical stimulation of deep brain nuclei for the treatment of movement disorders

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Mwiza Ushe

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mwiza Ushe, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University in St Louis

St Louis, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mwiza Ushe, M.D.

Role: CONTACT

3143625262

Facility Contacts

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Mwiza Ushe, M.D.

Role: primary

314-362-5262

Other Identifiers

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R01NS075321

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01NS097437

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R21NS098020

Identifier Type: NIH

Identifier Source: secondary_id

View Link

T32EB021955

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201101744

Identifier Type: -

Identifier Source: org_study_id

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