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Deep Brain Stimulation for Essential Tremor

This study is looking at how Deep Brain Stimulation (DBS) using a Medtronic Activa device affects the brain in people with Essential Tremor. Researchers want to understand changes in brain connections (structural connectivity) and how the brain works (functional network changes) after DBS. You might be able to join if you are 18 to 85 years old, have Essential Tremor that isn't caused by another condition, and your tremor is in your hands or arms, severe, and hasn't improved with medicines or causes bad side effects. The study will measure brain connectivity using MRI scans before DBS and again 24 months after DBS treatment begins. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 72 participants. It is not specified if it is randomized or blinded.
What's involved
You would have a Medtronic Activa device implanted. After 24 months of the DBS being on, it will be turned off for 3 days and then turned back on. MRI scans will be performed before the DBS implant and 24 months after DBS treatment starts.
Compensation
Not stated in the trial record.
Follow-up
Structural connectivity will be measured at baseline (before DBS implant) and 24 months after DBS treatment starts.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04758624

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

Recruiting
NAAges 18–85InterventionalBasic science
Northwell Health
~72 participants
Updated 2025-04-08 on ClinicalTrials.gov
What's tested:Deep Brain Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI
Measured over Baseline before DBS implant
+19 more outcomes measured

Conditions

Essential Tremor

Explore related trials

Essential Tremor

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Albert J Fenoy, MD · PRINCIPAL_INVESTIGATOR · Northwell Health

Who to contact

Mark Amandola
[email protected]
516 491 1054
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRIBaseline before DBS implant
  • Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI24 months after start of DBS
  • Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRIBaseline before DBS implant
  • Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI24 months after start of DBS
  • Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRIBaseline before DBS implant
  • Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI24 months after start of DBS
  • Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRIBaseline before DBS implant
  • Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI24 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)Baseline before DBS implant

    10 items are measured-each is scored from 0-4,higher number indicating more tremor

  • Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)24 months after start of DBS

    10 items are measured-each is scored from 0-4,higher number indicating more tremor

  • Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)Baseline before DBS is turned off

    10 items are measured-each is scored from 0-4,higher number indicating more tremor

  • Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)72 hours after DBS is turned off

    10 items are measured-each is scored from 0-4,higher number indicating more tremor

  • Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)During DBS placement surgery before active DBS

    10 items are measured-each is scored from 0-4,higher number indicating more tremor

  • 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

  • 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