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NCT04568681 · ClinicalTrials.gov registry record
Deep Brain Stimulation Effects in Dystonia
A clinical trial, sponsored by University of Florida.
- Completed
- Registry status
- 7
- Enrollment target
NCT04568681: Completed study, sponsored by University of Florida.
NCT04568681 is a clinical trial that has completed, run by University of Florida. The registered enrollment target is 7 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04568681 has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- 7 participants
- Enrollment target
Study Summary
Deep Brain Stimulation (DBS) is an effective therapy for patients with medically refractory primary dystonia. However, DBS programming for dystonia is not standardized and multiple clinic visits are frequently required to adequately control symptoms. We aim to longitudinally record brain signals from patients using a novel neurostimulator that can record brain signals. We will correlate brain signals to clinical severity scores to identify pathological rhythms in the absence of DBS, and we will study the effects of DBS on these signals in order to guide clinical programming. We are going to recruit patients who receive the Medtronic Percept device, which allows for brain signal recordings (this feature is FDA approved). The investigators will be conducting an observational study using this device to collect data that the subjects receive as standard of care.
Primary Outcome
A clinical scale fo dystonia severity (0-4, 0:no symptoms, 4:extreme)
Interventions
- DEVICE Deep brain stimulation (DBS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2020-11-05 |
| Est. Completion | 2022-07-12 |
What the finished NCT04568681 record still lists
NCT04568681 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 1 intervention - of which Deep brain stimulation (DBS) is the first listed.
NCT04568681 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04568681 about?
NCT04568681 is a clinical study titled "Deep Brain Stimulation Effects in Dystonia". Deep Brain Stimulation (DBS) is an effective therapy for patients with medically refractory primary dystonia. However, DBS programming for dystonia is not standardized and multiple clinic visits are frequently required to adequately control symptoms. We aim to longitudinally record brain signals fro...
What is the current status of trial NCT04568681?
This trial is currently completed. The enrollment target is 7 participants. The study started on 2020-11-05. Estimated completion is 2022-07-12.
What interventions are being tested in trial NCT04568681?
The interventions under investigation include: Deep brain stimulation (DBS) (DEVICE).
Who is sponsoring clinical trial NCT04568681?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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