Back to resultsElucidating the Temporality of Structural and Functional Connectivity Changes in Essential Tremor After Successful Deep Brain Stimulation to the Dentato-rubro-thalamic Tract
Primary Purpose
Essential Tremor
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Essential Tremor focused on measuring deep brain stimulation
Eligibility Criteria
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.
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Deep Brain Stimulation(DBS)
Arm Description
Outcomes
Primary Outcome Measures
Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI
Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI
Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI
Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI
Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
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
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
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
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
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
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
Spectral power recorded during intraoperative electrocorticography (ECoG)
Spectral power recorded during intraoperative electrocorticography (ECoG)
Secondary Outcome Measures
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).
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).
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).
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).
Tremor amplitude as assessed by accelerometric power
Tremor amplitude as assessed by accelerometric power
Full Information
NCT ID
NCT04758624
First Posted
February 12, 2021
Last Updated
September 7, 2022
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT04758624
Brief Title
Elucidating the Temporality of Structural and Functional Connectivity Changes in Essential Tremor After Successful Deep Brain Stimulation to the Dentato-rubro-thalamic Tract
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 4, 2021 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
deep brain stimulation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Deep Brain Stimulation(DBS)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation
Intervention Description
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 Information:
Title
Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI
Time Frame
Baseline before DBS implant
Title
Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI
Time Frame
24 months after start of DBS
Title
Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI
Time Frame
Baseline before DBS implant
Title
Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI
Time Frame
24 months after start of DBS
Title
Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Time Frame
Baseline before DBS implant
Title
Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Time Frame
24 months after start of DBS
Title
Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Time Frame
Baseline before DBS implant
Title
Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Time Frame
24 months after start of DBS
Title
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
Title
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
Title
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
Title
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
Title
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
Description
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Time Frame
Baseline before DBS implant
Title
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
Description
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Time Frame
24 months after start of DBS
Title
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
Description
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Time Frame
Baseline before DBS is turned off
Title
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
Description
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Time Frame
72 hours after DBS is turned off
Title
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
Description
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Time Frame
During DBS placement surgery before active DBS
Title
Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS)
Description
10 items are measured-each is scored from 0-4,higher number indicating more tremor
Time Frame
During DBS placement surgery during active DBS
Title
Spectral power recorded during intraoperative electrocorticography (ECoG)
Time Frame
During DBS placement surgery before active DBS
Title
Spectral power recorded during intraoperative electrocorticography (ECoG)
Time Frame
During DBS placement surgery during active DBS
Secondary Outcome Measure Information:
Title
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
Description
It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).
Time Frame
Baseline before DBS implant
Title
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
Description
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
Title
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
Description
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
Title
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
Description
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
Title
Tremor amplitude as assessed by accelerometric power
Time Frame
Baseline before DBS is turned off
Title
Tremor amplitude as assessed by accelerometric power
Time Frame
72 hours after DBS is turned off
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Ritter III
Phone
713-500-8914
Email
Robert.Ritter@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert J Fenoy, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Ritter III
Phone
713-500-8914
Email
Robert.Ritter@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Elucidating the Temporality of Structural and Functional Connectivity Changes in Essential Tremor After Successful Deep Brain Stimulation to the Dentato-rubro-thalamic Tract
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