Analysis of Clinical Outcomes in Patients Undergoing Magnetic Resonance-Guided Focused Ultrasound for Medication-Refractory Tremor
NCT ID: NCT07212244
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
240 participants
OBSERVATIONAL
2025-10-31
2032-09-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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
22 Years
ALL
No
Sponsors
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Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Dr. Nir Lipsman
Principal Investigator
Locations
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Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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6830
Identifier Type: -
Identifier Source: org_study_id
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