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NCT02712515 · ClinicalTrials.gov registry record

The Motor Network in Essential Tremor: Mechanisms of Therapy

A clinical trial of Parkinson's Disease and Essential Tremor, sponsored by University of Florida.

Completed
Registry status
21
Enrollment target
1
Study location

NCT02712515 is a study of Parkinson's Disease and Essential Tremor that has completed, run by University of Florida. The registered enrollment target is 21 participants, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02712515, a study of Parkinson's Disease and Essential Tremor, has completed, sponsored by University of Florida.

COMPLETED
Registry status
21 participants
Enrollment target
1
Study location

Study Summary

Essential tremor (ET) is among the most common movement disorders, and is the most prevalent tremor disorder. It is a progressive, degenerative brain disorder that results in increasingly debilitating tremor, and afflicts an estimated 7 million people in the US (2.2% of the population) and estimates from population studies worldwide range from 0.4% to 6.3%. ET is directly linked to progressive functional impairment, social embarrassment, and even depression. Intention (kinetic) tremor of the arms occurs in approximately half of ET patients, and is typically a slow tremor (\~5-10Hz) that occurs at the end of a purposeful movement, and is insidiously progressive over many years. Based on direct and indirect neurophysiological studies, it has been suggested that a pathological synchronous oscillation in a neuronal network involving the ventral intermediate nucleus (Vim) of the thalamus, the premotor (PM), primary motor (M1) cortices, and the cerebellum, may result in the production of ET. In spite of the numerous therapeutic modalities available, 65% of those suffering from upper limb tremor report serious difficulties during their daily lives. Deep brain stimulation (DBS) has emerged as an effective treatment option for those suffering from medically refractory ET. The accepted target for ET DBS therapy is the Vim thalamus. Vim projects to PM, M1, and supplementary motor areas (SMA) and receives afferents from the ipsilateral cerebellum. Moreover, electrophysiological recordings from Vim during stereotactic surgery have identified "tremor cells" that synchronously discharge with oscillatory muscle activity during tremor. Clinical and computational findings indicate that DBS suppresses tremor by masking these "burst driver" inputs to the thalamus. The overall goal is to investigate the neural signatures of tremor generation in the thalamocortical network by recording data during DBS implantation surgery. Investigators will record data from the macroelectrode implanted

Conditions Studied

Parkinson's Disease Essential Tremor

Interventions

  • PROCEDURE Deep brain stimulation implantation surgery
  • DEVICE Ad-Tech Medical Instrumentation Corp. electrodes/subdural strips
  • DEVICE FHC Guideline 4000+ system and/or Medtronic RC+S

Study Locations (1)

Florida

  • University of Florida - Gainesville

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2016-03-15
Est. Completion 2025-10-13

Sponsor

University of Florida

1,106 total trials

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What the Registry Record Tells You About NCT02712515

The ClinicalTrials.gov registry entry for NCT02712515 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (97% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Parkinson's Disease appearing as the primary indexed condition, and to 3 interventions - of which Deep brain stimulation implantation surgery is the first listed.

NCT02712515 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT02712515 about?

NCT02712515 is a clinical study titled "The Motor Network in Essential Tremor: Mechanisms of Therapy". Essential tremor (ET) is among the most common movement disorders, and is the most prevalent tremor disorder. It is a progressive, degenerative brain disorder that results in increasingly debilitating tremor, and afflicts an estimated 7 million people in the US (2.2% of the population) and estimates...

What is the current status of trial NCT02712515?

This trial is currently completed. The enrollment target is 21 participants. The study started on 2016-03-15. Estimated completion is 2025-10-13.

What conditions does trial NCT02712515 study?

This clinical trial studies the following conditions: Parkinson's Disease, Essential Tremor.

What interventions are being tested in trial NCT02712515?

The interventions under investigation include: Deep brain stimulation implantation surgery (PROCEDURE), Ad-Tech Medical Instrumentation Corp. electrodes/subdural strips (DEVICE), FHC Guideline 4000+ system and/or Medtronic RC+S (DEVICE).

Who is sponsoring clinical trial NCT02712515?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02712515 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.