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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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ClinicalTrials.gov Identifier: NCT04758624
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : September 9, 2022
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Albert J Fenoy, The University of Texas Health Science Center, Houston

Study Description
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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

Condition or disease Intervention/treatment Phase
Essential Tremor Device: Deep Brain Stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : December 4, 2021
Estimated Primary Completion Date : August 31, 2025
Estimated Study Completion Date : August 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Deep Brain Stimulation(DBS) 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.


Outcome Measures
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Primary Outcome Measures :
  1. Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI [ Time Frame: Baseline before DBS implant ]
  2. Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI [ Time Frame: 24 months after start of DBS ]
  3. Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI [ Time Frame: Baseline before DBS implant ]
  4. Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI [ Time Frame: 24 months after start of DBS ]
  5. Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI [ Time Frame: Baseline before DBS implant ]
  6. Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI [ Time Frame: 24 months after start of DBS ]
  7. Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI [ Time Frame: Baseline before DBS implant ]
  8. Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI [ Time Frame: 24 months after start of DBS ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. 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 ]
  13. Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS) [ Time Frame: Baseline before DBS implant ]
    10 items are measured-each is scored from 0-4,higher number indicating more tremor

  14. Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS) [ Time Frame: 24 months after start of DBS ]
    10 items are measured-each is scored from 0-4,higher number indicating more tremor

  15. Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS) [ Time Frame: Baseline before DBS is turned off ]
    10 items are measured-each is scored from 0-4,higher number indicating more tremor

  16. Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS) [ Time Frame: 72 hours after DBS is turned off ]
    10 items are measured-each is scored from 0-4,higher number indicating more tremor

  17. Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS) [ Time Frame: During DBS placement surgery before active DBS ]
    10 items are measured-each is scored from 0-4,higher number indicating more tremor

  18. Tremor as assessed by score on The Essential Tremor Rating Scale (TETRAS) [ Time Frame: During DBS placement surgery during active DBS ]
    10 items are measured-each is scored from 0-4,higher number indicating more tremor

  19. Spectral power recorded during intraoperative electrocorticography (ECoG) [ Time Frame: During DBS placement surgery before active DBS ]
  20. Spectral power recorded during intraoperative electrocorticography (ECoG) [ Time Frame: During DBS placement surgery during active DBS ]

Secondary Outcome Measures :
  1. Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA) [ Time Frame: Baseline before DBS implant ]
    It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).

  2. Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA) [ Time Frame: 24 months after start of DBS ]
    It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).

  3. Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA) [ Time Frame: Baseline before DBS is turned off ]
    It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).

  4. Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA) [ Time Frame: 72 hours after DBS is turned off ]
    It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia).

  5. Tremor amplitude as assessed by accelerometric power [ Time Frame: Baseline before DBS is turned off ]
  6. Tremor amplitude as assessed by accelerometric power [ Time Frame: 72 hours after DBS is turned off ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04758624


Contacts
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Contact: Robert Ritter III 713-500-8914 Robert.Ritter@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Robert Ritter III    713-500-8914    Robert.Ritter@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Albert J Fenoy, MD The University of Texas Health Science Center, Houston
More Information
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Responsible Party: Albert J Fenoy, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04758624    
Other Study ID Numbers: HSC-MS-20-0739
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: September 9, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Albert J Fenoy, The University of Texas Health Science Center, Houston:
deep brain stimulation
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Movement Disorders
Central Nervous System Diseases