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NCT04043403 · ClinicalTrials.gov registry record · NA
Bilateral Closed Loop Deep Brain Stimulation for Freezing of Gait Using Neural and Kinematic Feedback
A NA study, sponsored by Stanford University.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT04043403: Completed NA study, sponsored by Stanford University.
NCT04043403 is a NA study that has completed, run by Stanford University. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04043403, a NA study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
Deep Brain Stimulation of the subthalamic nucleus (STN) has become a standard of care, FDA-approved treatment for Parkinson's disease, with stimulation delivered at a constant amplitude and voltage, operating in an open-loop fashion that does not respond to a patient's current state. Although gait deficits and freezing of gait may initially respond to continuous open-loop deep brain stimulation (olDBS) and medication, the symptoms often recur over time. The episodic and predictable nature of FOG makes it well suited for adaptive DBS (aDBS) and a device that overcomes the limitations of traditional high frequency olDBS and is capable of adapting therapy either in the frequency or intensity domain transiently to treat FOG while also treating other PD signs such as tremor and bradykinesia. The purpose of this study is to determine the feasibility of an adaptive DBS system, that responds to patient-specific neural and kinematic variables with customized DBS parameters.
Interventions
- DEVICE Open Loop DBS
- DEVICE Adaptive (Closed Loop) DBS
- DEVICE Intermittent Open Loop DBS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-10-28 |
| Est. Completion | 2025-08-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04043403
The ClinicalTrials.gov registry entry for NCT04043403 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Open Loop DBS is the first listed.
NCT04043403 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04043403 about?
NCT04043403 is a clinical study titled "Bilateral Closed Loop Deep Brain Stimulation for Freezing of Gait Using Neural and Kinematic Feedback". Deep Brain Stimulation of the subthalamic nucleus (STN) has become a standard of care, FDA-approved treatment for Parkinson's disease, with stimulation delivered at a constant amplitude and voltage, operating in an open-loop fashion that does not respond to a patient's current state. Although gait d...
What is the current status of trial NCT04043403?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2019-10-28. Estimated completion is 2025-08-08.
What interventions are being tested in trial NCT04043403?
The interventions under investigation include: Open Loop DBS (DEVICE), Adaptive (Closed Loop) DBS (DEVICE), Intermittent Open Loop DBS (DEVICE).
Who is sponsoring clinical trial NCT04043403?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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