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

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

Study Overview

• Status: Recruiting
• Conditions: Essential Tremor
• Intervention / Treatment: Device: Deep Brain Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark Amandola; Phone Number: 516 491 1054; Email: mamandola@northwell.edu

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • Recruiting
      • North Shore University Hospital
      • Contact: Albert Fenoy
      • Sub-Investigator: Prashin Unadkat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deep Brain Stimulation(DBS)	Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)	It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).	Baseline before DBS implant
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)	It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).	24 months after start of DBS
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)	It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).	Baseline before DBS is turned off
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)	It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).	72 hours after DBS is turned off
Tremor amplitude as assessed by accelerometric power		Baseline before DBS is turned off
Tremor amplitude as assessed by accelerometric power		72 hours after DBS is turned off

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Albert J Fenoy, MD, Northwell Health

Publications and helpful links

General Publications

• Conner CR, Forseth KJ, Lozano AM, Ritter R 3rd, Fenoy AJ. Thalamo-cortical evoked potentials during stimulation of the dentato-rubro-thalamic tract demonstrate synaptic filtering. Neurotherapeutics. 2024 Jan;21(1):e00295. doi: 10.1016/j.neurot.2023.10.005. Epub 2023 Dec 19.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: deep brain stimulation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Dyskinesias; Tremor; Essential Tremor
• Other Study ID Numbers: HSC-MS-20-0739

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No