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

NCT07212244 | Recruiting

• 1 other identifier: 6830
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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 main questions it aims to answer are:

• 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:
• Clinical Rating Scale for Tremor (CRST)
• Neurological exams and adverse event monitoring
• Quality of Life in Essential Tremor (QUEST) questionnaire
• Scale for the Assessment and Rating of Ataxia (SARA)
• MRI imaging and neuropsychological testing

Conditions

Essential Tremor; Essential Tremor, Movement Disorders

Keywords

Focused Ultrasound; Thalamotomy; Hand tremor; MRI-guided focused ultrasound (MRgFUS); Primidone; Propranolol

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• Standardized Neurological Examination and Adverse Events (AEs)

  Assessments occur at baseline; Day 1; Week 12; and at 1, 2, and 3-year follow-up visits post-treatment.

• Quality of Life in Essential Tremor (QUEST) questionnaire

  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)

  Assessments occur at baseline; Day 1; Week 12; and at 1, 2, and 3-year follow-up visits post-treatment.

• Change in MRI Measures

  Assessments occur at baseline; Day 1; Week 12; and at 1-, 2-, and 3-year follow-up visits post-treatment.

Study Arms (1)

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.

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Essential Tremor; Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Nir Lipsman, MD, PhD, FRCSC

CONTACT

416-480-6954; Nir.Lipsman@sunnybrook.ca

Nadia Scantlebury, PhD

CONTACT

416- 480-6100; Nadia.Scantlebury@sunnybrook.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2032
• Last Updated: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)