Analysis of Clinical Outcomes in Patients Undergoing Magnetic Resonance-Guided Focused Ultrasound for Medication-Refractory Tremor

Sponsor
Sunnybrook Health Sciences Centre
Study ID
NCT07212244
Status
Recruiting
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Conditions

  • Essential Tremor
  • Essential Tremor, Movement Disorders

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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

Key Dates

First listed
Oct 8, 2025
Start date
Oct 31, 2025
Status verified
Sep 2025
Primary completion
Sep 30, 2031
Completion
Sep 30, 2032

Study Design

Enrollment
240 participants (estimated)

Arms

  • Arm: Cohort 1: Magnetic Resonance-Guided Focused Ultrasound (MRgFUS) Thalamotomy
    Patients with medication-refractory essential tremor who are scheduled to undergo MRgFUS thalamotomy at Sunnybrook Health Sciences Centre as part of standard of care. Eligible participants providing informed consent will be enrolled and followed prospectively for a minimum of 3 years to evaluate long-term efficacy and safety outcomes.

Primary Outcome Measure

Change in tremor severity measured by Clinical Rating Scale for Tremor (CRST) [ Time Frame: Assessments occur at baseline; Day 1; Week 12; and at 1, 2, and 3-year follow-up visits post-treatment. ]

Central Contacts

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