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NCT02649166 · ClinicalTrials.gov registry record · NA
Responsive Deep Brain Stimulator for Essential Tremor
A NA study of Essential Tremor, sponsored by University of Florida.
- Active
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT02649166: Active NA study of Essential Tremor, sponsored by University of Florida.
NCT02649166 is a NA study of Essential Tremor that is active but no longer recruiting, run by University of Florida. The registered enrollment target is 20 participants, below the 402-participant average among 41 other Essential Tremor trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02649166, a NA study of Essential Tremor, is active but no longer recruiting, sponsored by University of Florida.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Essential tremor is an incurable, degenerative brain disorder that results in increasingly debilitating tremor, and afflicts an estimated 7 million people in the US. In one study, 25% of essential tremor patients were forced to change jobs or take early retirement because of tremor. Essential tremor is directly linked to progressive functional impairment, social embarrassment, and even depression. The tremor associated with essential tremor is typically slow, involves the hands (and sometimes the head and voice), worsens with intentional movements, and is insidiously progressive over many years. Deep brain stimulation has emerged as a highly effective treatment for intractable, debilitating essential tremor. However, since the intention tremor of essential tremor is typically intermittent, and commonly absent at rest, the currently available continuous deep brain stimulation may be delivering unnecessary current to the brain that increases undesirable side effects such as slurred speech and walking difficulty, and hastens the depletion of device batteries, necessitating more frequent surgical procedures to replace spent pulse generators. The overall objective of this early feasibility study is to provide preliminary data on the safety and efficacy of "closed-loop" deep brain stimulation for intention tremor using novel deep brain stimulation devices capable of continuously sensing brain activity and delivering therapeutic stimulation only when necessary to suppress tremor.
Primary Outcome
\- Reduction in Clinical Rating Scale for Tremor after 6 months as an effect of continuous Vim deep brain stimulation The Fahn-Tolosa-Marin Tremor Rating Scale is a clinical rating scale assessing severity of tremor by body part from 0 (none) to 4 (severe). The scale is divided into three parts, where Part A assesses tremor severity at rest, during posture, and kinetic maneuvers for nine body parts; Part B assesses ability to perform specific motor tasks/functions (writing, drawing, and pouring
Conditions Studied
Interventions
- DEVICE Deep brain stimulation
- DEVICE Closed-loop deep brain stimulation
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-02-01 |
| Est. Completion | 2027-06-30 |
| Phase | NA |
What the registry record for NCT02649166 still lists
NCT02649166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 402-participant average among 41 other Essential Tremor trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Essential Tremor appearing as the primary indexed condition, and to 2 interventions - of which Deep brain stimulation is the first listed.
NCT02649166 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT02649166 about?
NCT02649166 is a clinical study titled "Responsive Deep Brain Stimulator for Essential Tremor". Essential tremor is an incurable, degenerative brain disorder that results in increasingly debilitating tremor, and afflicts an estimated 7 million people in the US. In one study, 25% of essential tremor patients were forced to change jobs or take early retirement because of tremor. Essential tremor...
What is the current status of trial NCT02649166?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2017-02-01. Estimated completion is 2027-06-30.
What conditions does trial NCT02649166 study?
This clinical trial studies the following conditions: Essential Tremor.
What interventions are being tested in trial NCT02649166?
The interventions under investigation include: Deep brain stimulation (DEVICE), Closed-loop deep brain stimulation (DEVICE).
Who is sponsoring clinical trial NCT02649166?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02649166 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02649166's enrollment target sits among peer trials
20 37th of 41 higher than 4 of 41 other Essential Tremor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Essential Tremor 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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