Elucidating the Temporality of Structural and Functional Connectivity Changes in Essential Tremor After Successful Deep Brain Stimulation to the Dentato-rubro-thalamic Tract

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-04

Study Completion Date

2026-08-31

Brief Summary

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The purpose of this study is to elucidate the structural connectivity of the dentato-rubro-thalamic tract (DRTt) and to detect functional network changes due to DRTt stimulation

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Detailed Description

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Conditions

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Essential Tremor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Deep Brain Stimulation(DBS)

Group Type EXPERIMENTAL

Deep Brain Stimulation

Intervention Type DEVICE

Medtronic Activa device will be implanted and administered clinically, except as part of the trial after 24 months of DBS being on it will be turned off for 3 days and will be turned back on.

Interventions

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Deep Brain Stimulation

Medtronic Activa device will be implanted and administered clinically, except as part of the trial after 24 months of DBS being on it will be turned off for 3 days and will be turned back on.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* the diagnosis of Essential Tremor, made by a movement disorder neurologist, where tremor is not secondary to any disease process or traumatic insult
* distal appendicular tremor, with minimal proximal component
* tremor refractory to multiple medication regimens and/or where the medications cause intolerable side effects
* tremor judged to be severely impacting their quality of life.

Exclusion Criteria

* significant neurological disorder
* significant dementia or neurocognitive limitations as assessed by neuropsychiatry (when necessary)
* severe psychiatric illness with suicidal ideations
* previous surgery to destroy the target region of the brain
* surgical contraindications to DBS
* current major medical problems that affect brain anatomy,neurochemistry, or function, e.g., liver insufficiency, kidney insufficiency, cardiovascular problems, systemic infections, cancer, hypothyroidism, auto-immune diseases, and any current of history of brain disorder (seizure disorder, stroke, dementia, meningitis, encephalitis, degenerative neurologic diseases and head injury with loss of consciousness for any period of time)
* family history of hereditary neurologic disorder, besides essential tremors ET
* floating metallic objects in the body
* pregnancy
* alcohol or substance abuse/dependence in the past 6 months.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No