Directional versus nondirectional deep brain stimulation for essential tremor
Directional Versus Nondirectional Deep Brain Stimulation of the VIM Thalamic Nucleus for Essential Tremor: Assessment of Therapeutic Window, Speech, Gait and Balance
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT04828798 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Portland, Oregon
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
Study contacts
- Study coordinator: Zoe Fanning
- Email: fanningz@ohsu.edu
- Phone: 503-494-7772
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.