Long-term outcomes after MRI-guided focused ultrasound thalamotomy for medication-resistant essential tremor
A Prospective, Long-term Analysis of Clinical Outcomes in Patients Undergoing Magnetic Resonance-Guided Focused Ultrasound for Medication-Refractory Tremor
This project will see if MRI-guided focused ultrasound thalamotomy provides lasting tremor relief and good long-term safety for people whose essential tremor has not responded to medications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07212244 on ClinicalTrials.gov |
What this trial studies
This is a single-centre, prospective observational cohort of about 240 adults treated with MR-guided focused ultrasound (MRgFUS) thalamotomy as part of standard care at Sunnybrook Health Sciences Centre. Participants will be followed for a minimum of three years with scheduled clinical and neuropsychological assessments. Outcomes include tremor severity (CRST), quality of life (QUEST), ataxia rating (SARA), MRI imaging, and adverse event monitoring. The study aims to characterize durability of benefit and long-term neurological and quality-of-life effects after the procedure.
Who should consider this trial
Good fit: Adults aged 22 or older with medication-refractory, moderate-to-severe hand-predominant essential tremor who are deemed suitable surgical candidates and can undergo MRI and attend follow-up visits.
Not a fit: People with MRI contraindications, significant medical comorbidities that make MRgFUS unsafe, those on anticoagulants near the procedure, or those whose tremor responds to medications are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the findings could show that MRgFUS thalamotomy delivers durable tremor reduction and improved quality of life with an acceptable long-term safety profile.
How similar studies have performed: Prior MRgFUS thalamotomy studies have shown meaningful short-to-mid-term tremor reduction, but prospective long-term (3+ year) outcome data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 22 years or older 2. Able and willing to give consent and to attend all visits 3. Diagnosed with essential tremor that is refractory to at least two first-line tremor medications 4. Confirmed to have moderate-to-severe hand tremor by the MRI guided Focused Ultrasound (MRgFUS) neurology team 5. Deemed suitable surgical candidates (decision-to-treat) by the MRgFUS neurosurgical team Exclusion Criteria: 1. Patients with standard contraindications to MRI such as non-MRI compatible implants or devices 2. Patients deemed clinically unfit to undergo MRgFUS thalamotomy due to health status including (but not limited to) pregnancy, advanced kidney disease, unstable cardiac status, severe hypertension, cerebrovascular disease, brain tumour, pulmonary disorders 3. Receiving anti-coagulants or drugs known to increase risk of hemorrhage within 2 weeks of MRgFUS procedure
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Nir Lipsman, MD, PhD, FRCSC
- Email: Nir.Lipsman@sunnybrook.ca
- Phone: 416-480-6954
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.