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NCT Number: NCT03992625

Clinical Outcomes for Deep Brain Stimulation

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University in St Louis

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Mwiza Ushe, M.D.

CONTACT

[email protected]

314-362-5262

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep brain stimulation

Device

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

Primary outcomes

  1. UPDRS

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mwiza Ushe, M.D.

CONTACT

[email protected]

3143625262

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)
  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2030
Study completion
2030
First posted
Jun 20, 2019
Registry last updated
Jun 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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