Directional Versus Nondirectional DBS for Essential Tremor

This study is looking at a treatment for Essential Tremor (ET), a condition causing shaking. It's testing Deep Brain Stimulation (DBS) of the VIM Thalamic nuclei, comparing a newer "directional" method with the standard "nondirectional" method. Researchers want to see if directional DBS creates a wider "therapeutic window" (meaning it can be adjusted more easily for good results) and if it causes fewer side effects like speech, balance, or walking problems. You might be able to join if you are 18 to 80 years old, have had ET for at least three years, and your tremor affects both upper limbs. The study aims to see if directional DBS works better and has fewer side effects than nondirectional DBS. The study status is unclear, and it plans to enroll 24 participants.

Study design
This is an interventional study planning to enroll 24 participants. It will compare directional and nondirectional deep brain stimulation.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, therapeutic window, is measured at 3 months.

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NCT04828798

Directional Versus Nondirectional DBS for ET

Recruiting
NAAges 18–80InterventionalTreatment
Oregon Health and Science University
~24 participants
Updated 2025-10-30 on ClinicalTrials.gov
What's tested:Deep brain stimulation of the VIM Thalamic nuclei

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Therapeutic window
Measured over 3 months
Essential Tremor
1 sites across 1 states
Oregon1

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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.
  • Therapeutic window3 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