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

Not Applicable

Recruiting

• Conditions: Essential Tremor
• Interventions: Device: Deep Brain Stimulation

• Registration Number: NCT04758624
• Lead Sponsor: Northwell Health

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-17
• Study Start: 2021-12-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Deep Brain Stimulation(DBS)	Deep Brain Stimulation	-

Primary Outcome Measures

Name	Time	Method
Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI	24 months after start of DBS
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)	During DBS placement surgery during active DBS	10 items are measured-each is scored from 0-4,higher number indicating more tremor
Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI	24 months after start of DBS
Spectral power recorded during intraoperative electrocorticography (ECoG)	During DBS placement surgery during active DBS
Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI	24 months after start of DBS
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)	72 hours after DBS is turned off
Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI	24 months after start of DBS

Secondary Outcome Measures

Name	Time	Method
Tremor amplitude as assessed by accelerometric power	72 hours after DBS is turned off
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)	72 hours after DBS is turned off	It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).

Trial Locations

Locations (1)

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States