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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 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.

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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.

Conditions Studied

Interventions

  • DEVICE Deep brain stimulation
  • DEVICE Closed-loop deep brain stimulation

Study Locations (1)

Florida

  • University of Florida - Gainesville

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2017-02-01
Est. Completion 2027-06-30
Phase NA

Sponsor

University of Florida

1,106 total trials

What the Registry Record Tells You About NCT02649166

The ClinicalTrials.gov registry entry for NCT02649166 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 402-participant average among 41 other Essential Tremor trials with a reported enrollment target (95% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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