Recruiting

MRgFUS Thalamotomy

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT07212244

Conditions

Essential Tremor

Essential Tremor, Movement Disorders

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Study Details

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:

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

Conditions

Essential Tremor

Essential Tremor, Movement Disorders

Study ID

NCT07212244

Start date

Oct, 2025

Status verified date

Sep, 2025

Completion date

Sep, 2032

Anticipated

Primary completion date

Sep, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Aged 22 years or older
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:

1. Patients with standard contraindications to MRI such as non-MRI compatible implants or devices
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

Study Design

Enrollment

240 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Change in tremor severity measured by Clinical Rating Scale for Tremor (CRST) [ Time Frame: Assessments occur at baseline; Day 1; Week 12; and at 1, 2, and 3-year follow-up visits post-treatment. ]

Central Contacts and Locations

Central contacts

Nir Lipsman, MD, PhD, FRCSC

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

Nadia Scantlebury, PhD

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

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Nadia Scantlebury, PhD

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

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Oct 8, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2025-10-08.