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Directional Versus Nondirectional DBS for ET

Directional Versus Nondirectional DBS for ET

Recruiting
18-80 years
All
Phase N/A

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Overview

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.

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

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.

Study details
    Essential Tremor

NCT04828798

Oregon Health and Science University

1 November 2025

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