Directional versus nondirectional deep brain stimulation for essential tremor
Official title: Directional Versus Nondirectional Deep Brain Stimulation of the VIM Thalamic Nucleus for Essential Tremor: Assessment of Therapeutic Window, Speech, Gait and Balance
Run by Oregon Health and Science University · NCT04828798 · Data updated 2026-11-12
This study will try directional deep brain stimulation in people with essential tremor to see if it controls tremor better and causes fewer speech, gait, or balance side effects than nondirectional DBS.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Status | Recruiting |
| Started | April 1, 2021 |
| Main results expected | October 1, 2027 |
| Study ends | October 1, 2029 |
| Registry record updated | October 30, 2025 |
| Trial ID | NCT04828798 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with medication-refractory bilateral upper-limb essential tremor for at least three years who are eligible for VIM DBS and have no prior DBS or thalamotomy and no implanted cardiac or neurostimulation devices.
✕Probably not a fit
Patients with secondary tremor (for example due to medication or another neurologic disease), task-specific or orthostatic tremor, prior DBS or thalamotomy, significant parkinsonism/dystonia/ataxia, or with cardiac pacemakers/defibrillators are unlikely to qualify or benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center proof-of-concept trial at Oregon Health & Science University compares directional and nondirectional stimulation of the VIM thalamus in people with essential tremor. Participants who meet eligibility will receive VIM DBS and be programmed with both directional and nondirectional settings optimized for tremor control while clinicians measure the therapeutic window for each mode. Objective and subjective measures of tremor severity, speech, gait, and balance will be collected to compare side effects and efficacy. The trial enrolls patients with bilateral upper-limb action tremor of at least three years' duration and excludes those with prior DBS or thalamotomy, secondary tremor syndromes, pacemakers/defibrillators, or other major neurologic disorders.
Why it matters
Potential benefit: If successful, directional DBS could provide a larger therapeutic window and better tremor control with fewer speech, gait, and balance side effects than nondirectional DBS.
How similar studies have gone: Previous work in movement disorders, including some Parkinson's and essential tremor reports, has suggested directional leads can widen the therapeutic window and reduce side effects, but this is a focused single-center proof-of-concept in ET.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Oregon Health & Science University
Portland, Oregon, United States Recruiting
Study contacts
- Study coordinator: Zoe Fanning
- Email: fanningz@ohsu.edu
- Phone: 503-494-7772
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.