Actively Recruiting
Analysis of Clinical Outcomes in Patients Undergoing Magnetic Resonance-Guided Focused Ultrasound for Medication-Refractory Tremor
Led by Sunnybrook Health Sciences Centre · Updated on 2025-10-08
240
Participants Needed
1
Research Sites
361 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Analysis of Clinical Outcomes in Patients Undergoing Magnetic Resonance-Guided Focused Ultrasound for Medication-Refractory Tremor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 22 years or older
- Able and willing to give consent and to attend all study visits
- Diagnosed with essential tremor not responding to at least two first-line tremor medications
- Confirmed moderate-to-severe hand tremor by the MRgFUS neurology team
- Approved as suitable surgical candidates by the MRgFUS neurosurgical team
You will not qualify if you...
- Have standard contraindications to MRI such as non-MRI compatible implants or devices
- Considered clinically unfit for MRgFUS thalamotomy due to health conditions including pregnancy, advanced kidney disease, unstable heart condition, severe hypertension, cerebrovascular disease, brain tumor, or lung disorders
- Taking anti-coagulants or medications that increase bleeding risk within 2 weeks before the MRgFUS procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
Research Team
N
Nir Lipsman, MD, PhD, FRCSC
CONTACT
N
Nadia Scantlebury, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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