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NCT03811405 · ClinicalTrials.gov registry record · NA
Physiology, Imaging and Modeling of Essential Tremor
A NA study of Parkinson Disease and Essential Tremor, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT03811405: Completed NA study of Parkinson Disease and Essential Tremor, sponsored by University of Florida.
NCT03811405 is a NA study of Parkinson Disease and Essential Tremor that has completed, run by University of Florida. The registered enrollment target is 12 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03811405, a NA study of Parkinson Disease and Essential Tremor, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
Study Summary
This project aims to investigate novel ways to deliver brain stimulation to Essential Tremor (ET) patients by introducing software changes to their existing devices. The study team aims to investigate safety and efficacy of these new stimulation parameters in patients with ET.
Primary Outcome
The study team will use computer simulation and virtual reconstruction of the brain from pre-operative MRI data to calculate the fiber activation threshold for the duration that each subject is on the home settings versus the biphasic settings. The investigators will assess the feasibility of the patterns to address the worsening of ET that may occur in 20% or more of the ET population. No fiber activation threshold data was collected for the DBS OFF state since the system was not active.
Conditions Studied
Interventions
- DEVICE Active biphasic pulse stimulation---Home Settings
- DEVICE Active biphasic pulse stimulation---VIN Biphasic
- DEVICE Active biphasic pulse stimulation---Stimulator Off
Study Locations (2)
Florida
- UF Health at the University of Florida - Gainesville
- McKnight Brain Institute--Fixel Center for Neurological Diseases - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2025-06-01 |
| Phase | NA |
What the finished NCT03811405 record still lists
NCT03811405 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 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Parkinson Disease appearing as the primary indexed condition, and to 3 interventions - of which Active biphasic pulse stimulation---Home Settings is the first listed.
NCT03811405 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03811405 about?
NCT03811405 is a clinical study titled "Physiology, Imaging and Modeling of Essential Tremor". This project aims to investigate novel ways to deliver brain stimulation to Essential Tremor (ET) patients by introducing software changes to their existing devices. The study team aims to investigate safety and efficacy of these new stimulation parameters in patients with ET.
What is the current status of trial NCT03811405?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2021-04-01. Estimated completion is 2025-06-01.
What conditions does trial NCT03811405 study?
This clinical trial studies the following conditions: Parkinson Disease, Essential Tremor, Dystonia.
What interventions are being tested in trial NCT03811405?
The interventions under investigation include: Active biphasic pulse stimulation---Home Settings (DEVICE), Active biphasic pulse stimulation---VIN Biphasic (DEVICE), Active biphasic pulse stimulation---Stimulator Off (DEVICE).
Who is sponsoring clinical trial NCT03811405?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03811405 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03811405's enrollment target sits among peer trials
12 268th of 297 higher than 24 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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