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

Essential Tremor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04758624
• Other study ID #: HSC-MS-20-0739
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

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