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NCT03582891 · ClinicalTrials.gov registry record · NA
The Motor Network in Parkinson's Disease and Dystonia: Mechanisms of Therapy
A NA study of Parkinson Disease and Dystonia, sponsored by University of California, San Francisco.
- Active
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT03582891: Active NA study of Parkinson Disease and Dystonia, sponsored by University of California, San Francisco.
NCT03582891 is a NA study of Parkinson Disease and Dystonia that is active but no longer recruiting, run by University of California, San Francisco. The registered enrollment target is 25 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03582891, a NA study of Parkinson Disease and Dystonia, is active but no longer recruiting, sponsored by University of California, San Francisco.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an exploratory pilot study to identify neural correlates of specific motor signs in Parkinson's disease (PD) and dystonia, using a novel totally implanted neural interface that senses brain activity as well as delivering therapeutic stimulation. Parkinson's disease and isolated dystonia patients will be implanted unilaterally or bilaterally with a totally internalized bidirectional neural interface, Medtronic Summit RC+S. This study includes three populations: ten PD patients undergoing deep brain stimulation in the subthalamic nucleus (STN), ten PD patients with a globus pallidus (GPi) target and five dystonia patients. All groups will test a variety of strategies for feedback-controlled deep brain stimulation, and all patients will undergo a blinded, small pilot clinical trial of closed-loop stimulation for thirty days.
Primary Outcome
Duration of 'on' stimulation time without dyskinesia in adaptive compared to standard open loop stimulation determined from the patients' motor diaries. The self-report motor diary is a validated method to capture this information. Every half-hour, patients indicate in this diary which of 4 categories (on, on with troubling dyskinesia, off, or asleep) best reflected their predominant symptoms for the prior 30 minutes. Patients will complete this diary for 3 consecutive days. The total time spent
Conditions Studied
Interventions
- DEVICE Summit RC+S for Motor
- DIAGNOSTIC_TEST 8-week pilot trial of Closed-loop vs. Open-loop Stimulation
- DEVICE Summit RC+S for Sleep
Study Locations (1)
California
- University of California at San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2028-03 |
| Phase | NA |
What the registry record for NCT03582891 still lists
NCT03582891 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Parkinson Disease appearing as the primary indexed condition, and to 3 interventions - of which Summit RC+S for Motor is the first listed.
NCT03582891 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03582891 about?
NCT03582891 is a clinical study titled "The Motor Network in Parkinson's Disease and Dystonia: Mechanisms of Therapy". This is an exploratory pilot study to identify neural correlates of specific motor signs in Parkinson's disease (PD) and dystonia, using a novel totally implanted neural interface that senses brain activity as well as delivering therapeutic stimulation. Parkinson's disease and isolated dystonia pati...
What is the current status of trial NCT03582891?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2018-10-01. Estimated completion is 2028-03.
What conditions does trial NCT03582891 study?
This clinical trial studies the following conditions: Parkinson Disease, Dystonia.
What interventions are being tested in trial NCT03582891?
The interventions under investigation include: Summit RC+S for Motor (DEVICE), 8-week pilot trial of Closed-loop vs. Open-loop Stimulation (DIAGNOSTIC_TEST), Summit RC+S for Sleep (DEVICE).
Who is sponsoring clinical trial NCT03582891?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03582891 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03582891's enrollment target sits among peer trials
25 225th of 297 higher than 67 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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