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NCT03582163 · ClinicalTrials.gov registry record
Longitudinal Outcomes of DBS in PD
A clinical trial, sponsored by Vanderbilt University Medical Center.
- Terminated
- Registry status
- 50
- Enrollment target
NCT03582163: Clinical Trial study, sponsored by Vanderbilt University Medical Center.
NCT03582163 is a clinical trial that was terminated before completion, run by Vanderbilt University Medical Center. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03582163 was terminated before completion, sponsored by Vanderbilt University Medical Center.
- TERMINATED
- Registry status
- 50 participants
- Enrollment target
Study Summary
Vanderbilt University Medical Center is one of the largest-volume DBS centers in the country. From 2007 through October 2017, 265 Parkinson's disease (PD) patients underwent deep brain stimulation (DBS), 168 of those implanted in subthalamic nucleus (STN) and 97 in globus pallidus interna (GPi). Pre-operatively, each patient is extensively evaluated with a battery of validated motor, cognitive, and mood instruments. This information is stored in RedCAP, a secure online database platform. In an attempt to capture longitudinal outcomes in this population of interest, we will recruit all PD patients two years or more status post DBS who are receiving regular care at Vanderbilt University Medical Center. Study participants will undergo a condensed evaluation of motor function (Unified Parkinson's Disease Rating Scale Part III), cognitive performance (Mini-Mental Status Examination), mood (Beck Depression Inventory), and quality of life (Parkinson's Disease Questionnaire-39). These results will be compared to baseline measures performed pre-operatively, allowing for assessment of interval change. STN and GPi DBS patients will be analyzed separately.
Primary Outcome
Parkinson's disease motor assessment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-08-09 |
| Est. Completion | 2024-12-31 |
Why NCT03582163 stopped before completion
NCT03582163 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03582163 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03582163 about?
NCT03582163 is a clinical study titled "Longitudinal Outcomes of DBS in PD". Vanderbilt University Medical Center is one of the largest-volume DBS centers in the country. From 2007 through October 2017, 265 Parkinson's disease (PD) patients underwent deep brain stimulation (DBS), 168 of those implanted in subthalamic nucleus (STN) and 97 in globus pallidus interna (GPi). Pre...
What is the current status of trial NCT03582163?
This trial is currently terminated. The enrollment target is 50 participants. The study started on 2018-08-09. Estimated completion is 2024-12-31.
Who is sponsoring clinical trial NCT03582163?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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