Long-Term Study of MR-Guided Focused Ultrasound Thalamotomy for Medication-Resistant Essential Tremor Evaluating Safety and Clinical Outcomes Over 3 Years at Sunnybrook Health Sciences Centre

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 procedures effects.

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