NCT03992625

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
43mo left

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Jan 2011Jan 2030

Study Start

First participant enrolled

January 3, 2011

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

June 20, 2019

Status Verified

June 1, 2019

Enrollment Period

19 years

First QC Date

June 13, 2019

Last Update Submit

June 19, 2019

Conditions

Parkinson DiseaseEssential TremorDystonia

Keywords

Deep brain stimulation

Outcome Measures

Primary Outcomes (1)

  • 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).

Interventions

Deep Brain StimulationDEVICE

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients receiving deep brain stimulation for movement disorders

You may qualify if:

  • Levodopa responsive Parkinson disease OR
  • Medically refractory Essential Tremor OR
  • Medically refractory Dystonia

You may not qualify if:

  • Dementia (Mattis Dementia Rating Scale \<130)
  • Structural abnormalities precluding intracranial surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St Louis

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseEssential TremorDystonia

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Mwiza Ushe, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mwiza Ushe, M.D.

CONTACT

3143625262ushem@wustl.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 13, 2019

First Posted

June 20, 2019

Study Start

January 3, 2011

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

June 20, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)