NCT04828798NARecruiting

Directional Versus Nondirectional DBS for ET

Oregon Health and Science University

Start Date

4/1/2021

Completion Date

10/1/2029

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.

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.

Eligibility Criteria

Age Range: 18 years to 80 years

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.

Interventions

DEVICE

Deep brain stimulation of the VIM Thalamic nuclei

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Conditions

Essential Tremor

Locations

Oregon Health & Science University

Portland, Oregon 97239

United States