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Directional Versus Nondirectional DBS for ET

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ClinicalTrials.gov Identifier: NCT04828798
Recruitment Status : Recruiting
First Posted : April 2, 2021
Last Update Posted : April 2, 2021
Sponsor:
Information provided by (Responsible Party):
Matthew Brodsky, Oregon Health and Science University

Study Description
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Brief Summary:
This will be a single center (OHSU) proof of concept trial to demonstrate that directional deep brain stimulation (DBS) creates a larger therapeutic window for the treatment of essential tremor (ET), effectively treats ET, and minimizes effects on speech, gait and balance compared to nondirectional DBS.

Condition or disease Intervention/treatment Phase
Essential Tremor Device: Deep brain stimulation of the VIM Thalamic nuclei Not Applicable

Detailed Description:

Specific Aims:

  1. To compare the therapeutic window (TW) of directional versus nondirectional deep brain stimulation for treatment of tremor.

    Hypothesis: directional DBS will result in a wider TW than nondirectional DBS.

  2. To compare the effects of directional versus nondirectional DBS on speech Hypothesis: Objective and subjective speech impairment will occur to a greater extent in nondirectional DBS versus directional DBS optimized for tremor control.
  3. To compare the effects of directional versus nondirectional DBS on balance and gait Hypothesis: Objective and subjective balance and gait impairment will occur to a greater extent in nondirectional DBS versus directional DBS optimized for tremor control.
  4. To assess efficacy for tremor of nondirectional and directional DBS in an optimized programming configuration Hypothesis: both directional and nondirectional DBS will significantly improve tremor compared to baseline.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double-blinded crossover design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Directional Versus Nondirectional Deep Brain Stimulation of the VIM Thalamic Nucleus for Essential Tremor: Assessment of Therapeutic Window, Speech, Gait and Balance
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : August 8, 2023
Estimated Study Completion Date : February 8, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Directional deep brain stimulation
Deep brain stimulation delivered in a directional manner within an axial plane
 Device: Deep brain stimulation of the VIM Thalamic nuclei
Deep brain stimulation of the thalamus, in a directional and nondirectional manner
Active Comparator: Nondirectional deep brain stimulation
Deep brain stimulation delivered in a nondirectional manner within an axial plane
 Device: Deep brain stimulation of the VIM Thalamic nuclei
Deep brain stimulation of the thalamus, in a directional and nondirectional manner


Outcome Measures
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Primary Outcome Measures :
  1. Therapeutic window [ Time Frame: 3 months ]
    Range of therapeutic current from clinical improvement to side effect threshold, measured in milliamps, within a range of 0.0 to 5.0 milliamps


Secondary Outcome Measures :
  1. Improvement of tremor [ Time Frame: 3 months ]
    Change in The Essential Tremor Rating Scale (TETRAS) combined score. Range = 0 to112. Higher score = worse outcome.

  2. Compare the effects of directional versus nondirectional DBS on self perception of speech [ Time Frame: 3 months ]
    Self Perception of speech: Subjects will rate their "ability to speak" on a VAS (from 0 [normal] to 100 mm [worst]) in each condition.

  3. Compare the effects of directional versus nondirectional DBS on balance and gait [ Time Frame: 3 months ]
    The Activities-specific Balance Confidence (ABC) scale is a 16-item self-report measure in which participants rate their balance confidence on a 0-100 scale (0 = 0 no confidence, 100 = 100 complete confidence).

  4. Compare the effects of directional versus nondirectional DBS on perceptual assessment of voice and speech [ Time Frame: 3 months ]
    Perceptual assessment of voice and speech will be completed with listeners judging a reading sample using a 100mm Visual Analog Scale (VAS).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A tremor syndrome of bilateral upper limb action tremor with at least 3 years' duration

Exclusion Criteria:

  • Patients who have decided not to receive DBS for control of their medication-refractory essential tremor.
  • Patients with secondary tremor (ie not Essential Tremor), such as side effects from medications, secondary to another identified neurologic disease (eg multiple sclerosis, -----Parkinson's disease, dystonia).
  • Prior history of deep brain stimulation.
  • Prior history of thalamotomy.
  • A history or signs of dystonia, ataxia or parkinsonism.
  • Task specific tremor.
  • Orthostatic tremor.
  • Patients with cardiac pacemakers, defibrillators, or neurostimulators.
  • Patients who require MRI, ECT, rTMS, or diathermy.
  • Subjects with other type of neurological disease or injury.
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): NCT04828798


Contacts
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Contact: Zoe Fanning 503-494-7772 fanningz@ohsu.edu

Locations
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United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Zoe Fanning    503-494-7772    fanningz@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
More Information
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Responsible Party: Matthew Brodsky, Associate Professor of Neurology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT04828798    
Other Study ID Numbers: 99920724
First Posted: April 2, 2021    Key Record Dates
Last Update Posted: April 2, 2021
Last Verified: March 2021
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
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Movement Disorders
Central Nervous System Diseases