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Recruiting NCT04758624

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

No phase Interventional Essential Tremor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deep Brain Stimulation.
Who it may be relevant to
Registry conditions: Essential Tremor. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

Interventions

  • 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.

Primary outcome measures

  • Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI [Time frame: Baseline before DBS implant]
  • Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI [Time frame: 24 months after start of DBS]
  • Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI [Time frame: Baseline before DBS implant]
  • Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI [Time frame: 24 months after start of DBS]
  • Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI [Time frame: Baseline before DBS implant]
  • Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI [Time frame: 24 months after start of DBS]
  • Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI [Time frame: Baseline before DBS implant]
  • Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI [Time frame: 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) [Time frame: Baseline before DBS implant]
  • Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI) [Time frame: 24 months after start of DBS]
Secondary outcome measures (6)
  • Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA) [Time frame: Baseline before DBS implant]
  • Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA) [Time frame: 24 months after start of DBS]
  • Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA) [Time frame: Baseline before DBS is turned off]
  • Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA) [Time frame: 72 hours after DBS is turned off]
  • Tremor amplitude as assessed by accelerometric power [Time frame: Baseline before DBS is turned off]
  • Tremor amplitude as assessed by accelerometric power [Time frame: 72 hours after DBS is turned off]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • North Shore University Hospital — Manhasset

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. PMID 38237402

Identifiers

NCT: NCT04758624 · HSC-MS-20-0739

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗