Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2021-04-01
2029-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Directional deep brain stimulation
Deep brain stimulation delivered in a directional manner within an axial plane
Deep brain stimulation of the VIM Thalamic nuclei
Deep brain stimulation of the thalamus, in a directional and nondirectional manner
Nondirectional deep brain stimulation
Deep brain stimulation delivered in a nondirectional manner within an axial plane
Deep brain stimulation of the VIM Thalamic nuclei
Deep brain stimulation of the thalamus, in a directional and nondirectional manner
Interventions
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Deep brain stimulation of the VIM Thalamic nuclei
Deep brain stimulation of the thalamus, in a directional and nondirectional manner
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Oregon Health and Science University
OTHER
Responsible Party
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Matthew Brodsky
Associate Professor of Neurology
Locations
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Oregon Health & Science University
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00020724
Identifier Type: -
Identifier Source: org_study_id
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