Essential TremorEssential Tremor, Movement Disorders
Study summary
The goal of this observational study is to evaluate the long-term efficacy and safety of MR-guided focused ultrasound (MRgFUS) thalamotomy in patients with medication-refractory essential tremor.
The main questions it aims to answer are:
1. Does MRgFUS thalamotomy provide sustained reduction in tremor severity over 3 years?
2. What are the long-term neurological and quality-of-life outcomes associated with this procedure?
Participants will:
* Undergo MRgFUS thalamotomy as part of standard of care at Sunnybrook Health Sciences Centre.
* Be followed prospectively for a minimum of 3 years with scheduled assessments including:
1. Clinical Rating Scale for Tremor (CRST)
2. Neurological exams and adverse event monitoring
3. Quality of Life in Essential Tremor (QUEST) questionnaire
4. Scale for the Assessment and Rating of Ataxia (SARA)
5. MRI imaging and neuropsychological testing
Eligibility
Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Change in tremor severity measured by Clinical Rating Scale for Tremor (CRST) — Assessments occur at baseline; Day 1; Week 12; and at 1, 2, and 3-year follow-up visits post-treatment. CRST is a validated scale assessing tremor severity through clinical examination and functional tasks. Tremor scores range from 0 (no tremor) to 32 for the dominant hand and 0 to 28 for the non-dominant hand, with higher scores indicating greater tremor severity. Change from baseline will be assessed. CRST measures will be videotaped following a standardized script.
Trial sites (1)
Facility
City
Region
Status
Sunnybrook Health Sciences Centre
Toronto
Ontario
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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