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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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). 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.
Primary Outcome
A Customized Adverse Events and Tolerability Questionnaire will measure the absence/presence and frequency of paresthesias, and muscle twitching relative to each stimulation condition
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 |
What the finished NCT04043403 record still lists
NCT04043403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Open Loop DBS is the first listed.
NCT04043403 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04043403's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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