NCT04758624

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Dec 2021Aug 2026

First Submitted

Initial submission to the registry

February 12, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

December 4, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

4.7 years

First QC Date

February 12, 2021

Last Update Submit

April 7, 2025

Conditions

Essential Tremor

Keywords

deep brain stimulation

Outcome Measures

Primary Outcomes (20)

  • 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 Outcomes (6)

  • Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)

    Baseline before DBS implant

  • Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)

    24 months after start of DBS

  • Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)

    Baseline before 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

  • Tremor amplitude as assessed by accelerometric power

    Baseline before DBS is turned off

  • +1 more secondary outcomes

Study Arms (1)

Deep Brain Stimulation(DBS)

EXPERIMENTAL
Device: Deep Brain Stimulation

Interventions

Deep Brain StimulationDEVICE

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.

Deep Brain Stimulation(DBS)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38237402RESULT

MeSH Terms

Conditions

Essential Tremor

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Albert J Fenoy, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Amandola

CONTACT

516 491 1054mamandola@northwell.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 17, 2021

Study Start

December 4, 2021

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

April 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)