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NCT01883973 · ClinicalTrials.gov registry record
MER Versus MRI Guidance DBS in Parkinson's Disease
A clinical trial, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- 7
- Enrollment target
NCT01883973: Completed study, sponsored by Baylor College of Medicine.
NCT01883973 is a clinical trial that has completed, run by Baylor College of Medicine. The registered enrollment target is 7 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01883973 has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- 7 participants
- Enrollment target
Study Summary
Most leading academic centers including Baylor College of Medicine (BCM) perform deep brain stimulation surgery in the awake patient using microelectrode recording to guide final electrode placement. Microelectrode recording is a means of analyzing the electrical activity of the brain, and assessing whether we have found the target for the deep brain stimulator electrode. However, no evidence exists that microelectrode recording improves patient outcomes. The use of microelectrode recording does extend the duration of surgery and there is evidence to suggest that microelectrode recording may increase the risk of bleeding in the brain during surgery.
Primary Outcome
The primary outcome measure for this study is the percentage improvement in the Unified Parkinson Disease Rating Scale (UPDRS) part III motor score from baseline to 6 months in patients who receiving stimulation in the "OFF" medication state. Secondary outcome measures include rate of radiographically visible intracranial hemorrhage and changes in neurocognitive function and quality of life testing. The student's two sample t-test will be used to perform the statistically comparisons.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2011-05 |
| Est. Completion | 2014-12 |
What the finished NCT01883973 record still lists
NCT01883973 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 7 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01883973 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01883973 about?
NCT01883973 is a clinical study titled "MER Versus MRI Guidance DBS in Parkinson's Disease". Most leading academic centers including Baylor College of Medicine (BCM) perform deep brain stimulation surgery in the awake patient using microelectrode recording to guide final electrode placement. Microelectrode recording is a means of analyzing the electrical activity of the brain, and assessing...
What is the current status of trial NCT01883973?
This trial is currently completed. The enrollment target is 7 participants. The study started on 2011-05. Estimated completion is 2014-12.
Who is sponsoring clinical trial NCT01883973?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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