Status:
RECRUITING
Analysis of Clinical Outcomes in Patients Undergoing Magnetic Resonance-Guided Focused Ultrasound for Medication-Refractory Tremor
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Essential Tremor
Essential Tremor, Movement Disorders
Eligibility:
All Genders
22+ years
Brief 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...
Detailed Description
This single-centre, prospective observational cohort study will evaluate long-term outcomes of MR-guided focused ultrasound (MRgFUS) thalamotomy for medication-refractory essential tremor at Sunnybroo...
Eligibility Criteria
Inclusion
- Aged 22 years or older
- Able and willing to give consent and to attend all visits
- Diagnosed with essential tremor that is refractory to at least two first-line tremor medications
- Confirmed to have moderate-to-severe hand tremor by the MRI guided Focused Ultrasound (MRgFUS) neurology team
- Deemed suitable surgical candidates (decision-to-treat) by the MRgFUS neurosurgical team
Exclusion
- Patients with standard contraindications to MRI such as non-MRI compatible implants or devices
- 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
- Receiving anti-coagulants or drugs known to increase risk of hemorrhage within 2 weeks of MRgFUS procedure
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2032
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT07212244
Start Date
October 1 2025
End Date
September 1 2032
Last Update
October 8 2025
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5