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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:
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:
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 Sunnybrook Health Sciences Centre. It is anticipated that about 240 people will be recruited into this study over the next 6 years. It is expected that this study will take 6 years to complete and that results will be known in 6-7 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in tremor severity measured by Clinical Rating Scale for Tremor (CRST) | CRST is a validated scale assessing tremor severity through clinical examination and functional tasks. Tremor scores range from 0 (no tremor) to 32 for the dominant hand and 0 to 28 for the non-dominant hand, with higher scores indicating greater tremor severity. Change from baseline will be assessed. CRST measures will be videotaped following a standardized script. | Assessments occur at baseline; Day 1; Week 12; and at 1, 2, and 3-year follow-up visits post-treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Standardized Neurological Examination and Adverse Events (AEs) | Adverse events will be recorded and graded according to CTCAE v5.0. AEs will be recorded and categorized according to severity, and relationship to procedure. | Assessments occur at baseline; Day 1; Week 12; and at 1, 2, and 3-year follow-up visits post-treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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Adults aged 22 years and older with medication-refractory essential tremor and moderate-to-severe hand tremor who are scheduled to undergo MR-guided focused ultrasound (MRgFUS) thalamotomy at Sunnybrook Health Sciences Centre as part of standard of care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nir Lipsman, MD, PhD, FRCSC | Contact | 416-480-6954 | Nir.Lipsman@sunnybrook.ca | |
| Nadia Scantlebury, PhD | Contact | 416- 480-6100 | 64390 | Nadia.Scantlebury@sunnybrook.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| D009069 | Movement Disorders |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Quality of Life in Essential Tremor (QUEST) questionnaire |
The QUEST is a self-reported, validated survey scoring the physical, psychosocial, communication, hobbies/leisure and work/finance domains of the life of a patient with Essential Tremor. Participants rate their level of agreeance with 30 statements on a 5-point scale (0 to 4), for a maximum score of 120. Higher scores reflect poorer quality of life. |
| Assessments occur at baseline; Week 12; and at 1, 2, and 3-year follow-up visits post-treatment. |
| Scale for the Assessment and Rating of Ataxia (SARA) | The SARA is a validated, comprehensive ataxia scale, and comprises 8 items carrying a maximum total score of 40 points. Higher scores suggest increased ataxia. The SARA will be used to compare degree of ataxia between baseline and the follow-up visits. In particular, the SARA will be used to assess changes in gait and stance associated with the procedure. | Assessments occur at baseline; Day 1; Week 12; and at 1, 2, and 3-year follow-up visits post-treatment. |
| Change in MRI Measures | MRI sequences (T1, T2*, DTI, resting state fMRI) will be obtained to assess treatment-related changes and safety. | Assessments occur at baseline; Day 1; Week 12; and at 1-, 2-, and 3-year follow-up visits post-treatment. |