Recruiting

Deep Brain Stimulation

Sponsor:

Northwell Health

Code:

NCT04758624

Conditions

Essential Tremor

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Deep Brain Stimulation

Study Details

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

Conditions

Essential Tremor

Study ID

NCT04758624

Start date

Dec 4, 2021

Status verified date

Apr, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

72 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Deep Brain Stimulation(DBS)

Interventions

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 measure

  • 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 ]
  • 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 ]
  • 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 ]
  • Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS) [ Time Frame: Baseline before DBS implant ]
  • Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS) [ Time Frame: 24 months after start of DBS ]
  • Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS) [ Time Frame: Baseline before DBS is turned off ]
  • Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS) [ Time Frame: 72 hours after DBS is turned off ]
  • Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS) [ Time Frame: During DBS placement surgery before active DBS ]
  • Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS) [ Time Frame: During DBS placement surgery during active DBS ]
  • Spectral power recorded during intraoperative electrocorticography (ECoG) [ Time Frame: During DBS placement surgery before active DBS ]
  • Spectral power recorded during intraoperative electrocorticography (ECoG) [ Time Frame: During DBS placement surgery during active DBS ]

Central Contacts and Locations

Central contacts

Mark Amandola

516 491 1054mamandola@northwell.edu

Locations

North Shore University Hospital

Recruiting

Manhasset, New York, United States, 11030

More Information

Sponsor

Northwell Health

Last update posted

Apr 8, 2025

Last verified

Apr, 2025

Keywords

  • deep brain stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2025-04-08.