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NCT Number: NCT07212244

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

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

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Essential Tremor, Movement Disorders Movement Disorders Nervous System Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location status: Recruiting

Location contact

Nadia Scantlebury, PhD

CONTACT

[email protected]

416-480-6100 ext. 64390

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. Standardized Neurological Examination and Adverse Events (AEs)

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

    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.

  2. Quality of Life in Essential Tremor (QUEST) questionnaire

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

    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.

  3. Scale for the Assessment and Rating of Ataxia (SARA)

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

    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.

  4. Change in MRI Measures

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

    MRI sequences (T1, T2*, DTI, resting state fMRI) will be obtained to assess treatment-related changes and safety.

Study contacts

Contact information is provided by the study sponsor or research team.

Nadia Scantlebury, PhD

CONTACT

[email protected]

416- 480-6100 ext. 64390

Nir Lipsman, MD, PhD, FRCSC

CONTACT

[email protected]

416-480-6954

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

A Prospective, Long-term Analysis of Clinical Outcomes in Patients Undergoing Magnetic Resonance-Guided Focused Ultrasound for Medication-Refractory Tremor

Important dates

Study start
2025
Primary completion
2031
Study completion
2032
First posted
Oct 8, 2025
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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