Actively Recruiting
Long-term Analysis of Outcomes in Patients Undergoing MR-Guided Focused Ultrasound Thalamotomy for Medication-Refractory Essential Tremor
Led by Sunnybrook Health Sciences Centre · Updated on 2025-10-08
240
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term outcomes of MR-guided focused ultrasound (MRgFUS) thalamotomy in patients with essential tremor that does not respond to medication. This observational study aims to find out if MRgFUS thalamotomy provides sustained tremor reduction over three years and to assess the neurological and quality-of-life effects of this procedure. Approximately 240 participants will be followed at a single center over about six years. Participants will undergo MRgFUS thalamotomy as part of their standard care at Sunnybrook Health Sciences Centre. After treatment, they will be monitored prospectively for at least three years. Scheduled assessments include clinical rating scales for tremor and ataxia, neurological exams, adverse event monitoring, quality-of-life questionnaires, MRI scans, and neuropsychological testing at multiple time points from baseline through three years post-treatment. Participants will have visits at baseline, Day 1, Week 12, and annually at 1, 2, and 3 years after treatment. During these visits, researchers will evaluate changes in tremor severity using the Clinical Rating Scale for Tremor and assess neurological status, quality of life, ataxia symptoms, and MRI changes. Safety and adverse events will also be closely monitored throughout the follow-up period, ensuring comprehensive long-term data collection on the procedure’s effects.
CONDITIONS
Brief 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 attend all study visits
- Diagnosed with essential tremor that does not respond to at least two first-line tremor medications
- Confirmed moderate-to-severe hand tremor by the MRgFUS neurology team
- Deemed suitable surgical candidates by the MRgFUS neurosurgical team
You will not qualify if you...
- Standard contraindications to MRI such as non-MRI compatible implants or devices
- Clinically unfit for MRgFUS thalamotomy due to health conditions including pregnancy, advanced kidney disease, unstable heart status, severe hypertension, cerebrovascular disease, brain tumour, or lung disorders
- Currently taking blood thinners or drugs that increase bleeding risk within two weeks of the procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 6 years during recruitment period
Participants are screened for eligibility to participate in the trial.
Duration - Day 1
Participants scheduled for MR-guided focused ultrasound thalamotomy as part of standard care are enrolled and their baseline assessments are completed.
1 visit (in-person)
Duration - At least 3 years
Participants are followed for a minimum of 3 years to evaluate long-term efficacy and safety outcomes after MR-guided focused ultrasound thalamotomy.
Visits at Week 12, and at 1, 2, and 3 years post-treatment
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
N
Nadia Scantlebury, PhD
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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