Status:
RECRUITING
Directional Versus Nondirectional DBS for ET
Lead Sponsor:
Oregon Health and Science University
Conditions:
Essential Tremor
Eligibility:
All Genders
18-80 years
Phase:
NA
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), ...
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...
Eligibility Criteria
Inclusion
- A tremor syndrome of bilateral upper limb action tremor with at least 3 years' duration
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04828798
Start Date
April 1 2021
End Date
October 1 2029
Last Update
October 30 2025
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239