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NCT Number: NCT04758624

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

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location status: Recruiting

Location contact

Albert Fenoy

CONTACT

Prashin Unadkat

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deep brain stimulation

Device

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 outcomes

  1. Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI

    Time frame: Baseline before DBS implant

  2. Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI

    Time frame: 24 months after start of DBS

  3. Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI

    Time frame: Baseline before DBS implant

  4. Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI

    Time frame: 24 months after start of DBS

  5. Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI

    Time frame: Baseline before DBS implant

  6. Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI

    Time frame: 24 months after start of DBS

  7. Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI

    Time frame: Baseline before DBS implant

  8. Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI

    Time frame: 24 months after start of DBS

  9. 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

  10. 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

  11. Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)

    Time frame: Baseline before DBS is turned off

  12. Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)

    Time frame: 72 hours after DBS is turned off

  13. Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)

    Time frame: Baseline before DBS implant

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

  14. Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)

    Time frame: 24 months after start of DBS

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

  15. Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)

    Time frame: Baseline before DBS is turned off

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

  16. Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)

    Time frame: 72 hours after DBS is turned off

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

  17. Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)

    Time frame: During DBS placement surgery before active DBS

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

  18. Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)

    Time frame: During DBS placement surgery during active DBS

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

  19. Spectral power recorded during intraoperative electrocorticography (ECoG)

    Time frame: During DBS placement surgery before active DBS

  20. Spectral power recorded during intraoperative electrocorticography (ECoG)

    Time frame: During DBS placement surgery during active DBS

Secondary outcomes

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

    Time frame: Baseline before DBS implant

    It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).

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

    Time frame: 24 months after start of DBS

    It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).

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

    Time frame: Baseline before DBS is turned off

    It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).

  4. 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

    It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).

  5. Tremor amplitude as assessed by accelerometric power

    Time frame: Baseline before DBS is turned off

  6. Tremor amplitude as assessed by accelerometric power

    Time frame: 72 hours after DBS is turned off

Study contacts

Contact information is provided by the study sponsor or research team.

Mark Amandola

CONTACT

[email protected]

516 491 1054

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2021
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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