Essential TremorNCT07212244
Analysis of Clinical Outcomes in Patients Undergoing Magnetic Resonance-Guided Focused Ultrasound for Medication-Refractory Tremor
An observational study of Essential Tremor and Essential Tremor, Movement Disorders, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Essential Tremor, Essential Tremor, Movement Disorders
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2025to Sep 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Nadia Scantlebury, PhD, 416-480-6100 ext. 64390, Nadia.Scantlebury@sunnybrook.ca
About this study
Official title: A Prospective, Long-term 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:
Read more
- Does MRgFUS thalamotomy provide sustained reduction in tremor severity over 3 years?
- 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:
- 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
Read the detailed description
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.
- Keywords
- Focused Ultrasound, Thalamotomy, Hand tremor, MRI-guided focused ultrasound (MRgFUS), Primidone, Propranolol
- Medical subject headings
- Essential Tremor, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: Assessments occur at baseline; Day 1; Week 12; and at 1-, 2-, and 3-year follow-up visits post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study startOct 2025 (estimated)
- Primary completionSep 2031 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nir Lipsman, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212244
- Sponsor's protocol ID
- 6830
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Long-term Analysis of Clinical Outcomes in Patients Undergoing Magnetic Resonance-Guided Focused Ultrasound for Medication-Refractory Tremor
- ClinicalTrials.gov ID
- NCT07212244
- Acronym / sponsor ID
- 6830
- Keywords
- Focused Ultrasound, Thalamotomy, Hand tremor, MRI-guided focused ultrasound (MRgFUS), Primidone, Propranolol
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does MRgFUS thalamotomy provide sustained reduction in tremor severity over 3 years?
- 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:
- 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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Tremor and Essential Tremor, Movement Disorders, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nir Lipsman, MD, PhD, FRCSC (416-480-6954, Nir.Lipsman@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.