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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04758624
Other study ID # HSC-MS-20-0739
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 4, 2021
Est. completion date August 31, 2026

Study information

Verified date March 2024
Source Northwell Health
Contact Robert Ritter III
Phone 713-500-8914
Email Robert.Ritter@uth.tmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date August 31, 2026
Est. primary completion date August 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
Northwell Health National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI Baseline before DBS implant
Primary Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI 24 months after start of DBS
Primary Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI Baseline before DBS implant
Primary Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI 24 months after start of DBS
Primary Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI Baseline before DBS implant
Primary Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI 24 months after start of DBS
Primary Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI Baseline before DBS implant
Primary Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI 24 months after start of DBS
Primary Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI) Baseline before DBS implant
Primary 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
Primary 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
Primary 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
Primary 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 Baseline before DBS implant
Primary 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 24 months after start of DBS
Primary 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 Baseline before DBS is turned off
Primary 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 72 hours after DBS is turned off
Primary 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 During DBS placement surgery before active DBS
Primary 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 During DBS placement surgery during active DBS
Primary Spectral power recorded during intraoperative electrocorticography (ECoG) During DBS placement surgery before active DBS
Primary Spectral power recorded during intraoperative electrocorticography (ECoG) During DBS placement surgery during active DBS
Secondary 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). Baseline before DBS implant
Secondary 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). 24 months after start of DBS
Secondary 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). Baseline before DBS is turned off
Secondary 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). 72 hours after DBS is turned off
Secondary Tremor amplitude as assessed by accelerometric power Baseline before DBS is turned off
Secondary Tremor amplitude as assessed by accelerometric power 72 hours after DBS is turned off
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