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

Northwell Health72 enrolled

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

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Essential Tremor

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

North Shore University Hospital

Manhasset, New York, United States

RECRUITING

Outcomes

Primary Outcomes

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

Central Contacts

Mark Amandola

CONTACT

516 491 1054 mamandola@northwell.edu

Data from ClinicalTrials.gov

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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)

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

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

Secondary Outcomes

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

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

Time frame: Baseline before DBS implant

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

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

Time frame: 24 months after start of DBS

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

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

Time frame: Baseline before DBS is turned off

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

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

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