Multiple SclerosisMSFUS001NCT04279912
MR-Guided Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis
A study testing Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis in people with Multiple Sclerosis, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
This study will be a single-centre, prospective, single-arm, open-label pilot trial assessing the feasibility and safety of unilateral MR-guided focused ultrasound (MRgFUS) thalamotomy for refractory hand tremor in up to 12 patients with multiple sclerosis (relapsing-remitting, primary progressive or secondary… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jan 2020to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female aged 18-80 years
- Willing and able to give consent and attend all study visits
- A confirmed diagnosis of medication-refractory, MS-related hand tremor
- No clinical evidence of relapse over 12 months or more before enrollment
- No MRI activity over 3 months or more before enrollment
- Presence of disabling postural or kinetic tremor
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- Unsatisfactory tremor response to adequate trials of at least two medications
- Able to communicate sensations during the treatment
- Stable doses of all medications for 30 days prior to and during study
Who cannot join
- Severe cerebellar dysfunction measured by Scale for the Assessment and Rating of Ataxia (>35 out of 40)
- Severe weakness or sensory loss in arm contralateral to the side of the brain considered for MRgFUS
- Evidence of a superimposed or atypical movement disorder
- Unstable cardiac status such as angina pectoris, congestive heart failure, etc.
- Severe hypertension
- Patients with standard contraindications for MR imaging
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- History of abnormal bleeding and/or coagulopathy
- Ischemic or hemorrhagic stroke within 6 months
- Symptoms and signs of increased intracranial pressure (e.g. headache, nausea, vomiting, lethargy, and papilledema)
- Untreated, uncontrolled sleep apnea
- Active or suspected acute or chronic uncontrolled infection
- Receiving anticoagulant or antiplatelet therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage within one month of MRgFUS surgery
- Not able or willing to tolerate the required prolonged stationary supine position during treatment
- Participating or have participated in another clinical trial in the last 30 days
- Unable to communicate with the investigator and staff
- Presence of neurodegenerative disease or significant cognitive impairment
- Presence of significant cognitive impairment (≤24 on MMSE)
- Uncontrolled major psychiatric disorder or suicidal ideation
- Risk factors for intraoperative or postoperative bleeding or documented coagulopathy
- Presence of brain tumours
- Any illness that in the investigator's opinion preclude participation in this study
- Pregnancy or lactation
- Legal incapacity or limited legal capacity
- Deep Brain Stimulation or a prior stereotactic ablation of the basal ganglia
- A history of seizures within the past year
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Nadia Scatlebury, PhD, +1 416-480-6100 ext. 4390, nadia.scantlebury@sunnybrook.ca
About this study
Official title: A Feasibility and Safety Clinical Trial of the Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis
This study will be a single-centre, prospective, single-arm, open-label pilot trial assessing the feasibility and safety of unilateral MR-guided focused ultrasound (MRgFUS) thalamotomy for refractory hand tremor in up to 12 patients with multiple sclerosis (relapsing-remitting, primary progressive or secondary progressive MS). This study will be conducted at the Focused Ultrasound Centre of Excellence and MS Clinic located at Sunnybrook Health Sciences Centre/ University of Toronto. Patients with stable MS and refractory hand tremor providing informed consent will receive MRgFUS thermal ablation of the Vim thalamus contralateral to the most affected side of the body (frequently this will be the dominant hand).
- Conditions
- Multiple Sclerosis
- Being tested
- Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis
- Keywords
- Tremor, Multiple Sclerosis, MR-guided Focused Ultrasound
- Medical subject headings
- Multiple Sclerosis, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple SclerosisDevice
The intervention is MRIgFUS thermal ablation of the ventral intermedius (Vim) thalamus contralateral to the most affected side of the body.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Multiple Sclerosis and Tremor | Experimental | Participants will undergo MRgFUS thermal ablation of the ventral intermedius (Vim) thalamus contralateral to the most affected side of the body. Receives: Device: Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite safety outcome of MRgFUS thalamotomy
Composite outcome of detectable Vim lesion on MRI scan; AND lack of new-onset or worsening of contralateral upper limb sensory loss or weakness
Measured: 90 days
Secondary outcomes (8)
Incidence and severity of adverse events related to MRgFUS thalamotomy
Incidence and severity of adverse events possibly, probably or definitely related to the MRgFUS procedure at 1, 7, 30, 90 and 120 days after treatment.
Measured: 1, 7, 30, 90 and 120 days
Incidence and severity of adverse events related to MS disease relapse or progression
Incidence and severity of AEs possibly, probably or definitely-related to MS disease relapse or progression (based on clinical assessment) over 30 and 90 days.
Measured: 30 and 90 days
Changes from baseline in the EDSS (Expanded Disability Status Scale) scores
Changes from baseline in the EDSS scores at 30 and 90 days. This is a scale to of quantify disability in multiple sclerosis. Score: 0 to 10 with higher scores meaning worse outcome.
Measured: 30 and 90 days
Changes from baseline in the SARA (Scale for Assessment and Rating of Ataxia) scores
Changes from baseline in the SARA scores at 30 and 90 days. This is a scale to of quantify function and disability related to ataxia. Score: 0 to 40 with higher scores meaning worse outcome.
Measured: 30 and 90 days
Changes from baseline in the speech intelligibility (percentage of intelligible words recorded during standardized passage reading)
Changes from baseline in intelligibility percentage at 30 and 90 days. Score: 0 to 100% with higher scores meaning better outcome.
Measured: 30 and 90 days
Changes from baseline in QUEST (Quality of Life in Essential Tremor Questionnaire) scores
Changes from baseline in QUEST scores at 30 and 90 days. This is a 30-item scale developed specifically for patients with essential tremor to measure items impacting perceived quality of life (QOL) that generic QOL measures do not effectively capture, including activities of daily living that are affected by tremor. Higher scores mean worse outcome.
Measured: 30 and 90 days
Change from baseline in the CRST (Clinical Rating Scale for Tremors)
Change from baseline in the treated upper limb tremor subscore of the CRST at 30 and 90 days. Score: 0 to 32 with higher scores meaning worse outcome.
Measured: 30 and 90 days
Composite safety outcome of MRgFUS thalamotomy
Composite outcome of detectable Vim lesion on MRI scan; AND lack of new-onset or worsening of contralateral upper limb sensory loss or weakness
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start16 Jan 2020
- Primary completionMar 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-centre, prospective, single-arm, open-label pilot trial assessing the feasibility and safety of MRgFUS thalamotomy for refractory hand tremor in up to 6 patients with multiple sclerosis
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Multiple Sclerosis Society of Canada
- Responsible party
- Principal investigator, Dr. Nir Lipsman, Sunnybrook Health Sciences Centre
- Investigators
- Nir Lipsman, MD, PhD, Principal investigator, Sunnybrook Health Sciences CentreAgessandro Abrahao, MD, MSc, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279912
- Sponsor's protocol ID
- 029-2019
- Acronym
- MSFUS001
- Status last verified
- Feb 2020
- First submitted
- 31 Jan 2020
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility and Safety Clinical Trial of the Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04279912
- Acronym / sponsor ID
- MSFUS001 / 029-2019
- Conditions
- Multiple Sclerosis
- Keywords
- Tremor, Multiple Sclerosis, MR-guided Focused Ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Multiple Sclerosis Society of Canada
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 21 Feb 2020 (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.
This study will be a single-centre, prospective, single-arm, open-label pilot trial assessing the feasibility and safety of unilateral MR-guided focused ultrasound (MRgFUS) thalamotomy for refractory hand tremor in up to 12 patients with multiple sclerosis (relapsing-remitting, primary progressive or secondary progressive MS). This study will be conducted at the Focused Ultrasound Centre of Excellence and MS Clinic located at Sunnybrook Health Sciences Centre/ University of Toronto. Patients with stable MS and refractory hand tremor providing informed consent will receive MRgFUS thermal ablation of the Vim thalamus contralateral to the most affected side of the body (frequently this will be the dominant hand).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-centre, prospective, single-arm, open-label pilot trial assessing the feasibility and safety of MRgFUS thalamotomy for refractory hand tremor in up to 6 patients with multiple sclerosis
| Arm | Type | Receives |
|---|---|---|
| Patients with Multiple Sclerosis and Tremor | Experimental | Device: Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple SclerosisParticipants will undergo MRgFUS thermal ablation of the ventral intermedius (Vim) thalamus contralateral to the most affected side of the body. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or Female aged 18-80 years
- Willing and able to give consent and attend all study visits
- A confirmed diagnosis of medication-refractory, MS-related hand tremor
- No clinical evidence of relapse over 12 months or more before enrollment
- No MRI activity over 3 months or more before enrollment
Key exclusion criteria (25 listed)
- Severe cerebellar dysfunction measured by Scale for the Assessment and Rating of Ataxia (>35 out of 40)
- Severe weakness or sensory loss in arm contralateral to the side of the brain considered for MRgFUS
- Evidence of a superimposed or atypical movement disorder
- Unstable cardiac status such as angina pectoris, congestive heart failure, etc.
- Severe hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple SclerosisThe intervention is MRIgFUS thermal ablation of the ventral intermedius (Vim) thalamus contralateral to the most affected side of the body. | Device | Patients with Multiple Sclerosis and Tremor |
Primary outcome
Composite safety outcome of MRgFUS thalamotomy
Time frame: 90 days
Composite outcome of detectable Vim lesion on MRI scan; AND lack of new-onset or worsening of contralateral upper limb sensory loss or weakness
8 secondary outcomes
Incidence and severity of adverse events related to MRgFUS thalamotomy
Time frame: 1, 7, 30, 90 and 120 days
Incidence and severity of adverse events related to MS disease relapse or progression
Time frame: 30 and 90 days
Changes from baseline in the EDSS (Expanded Disability Status Scale) scores
Time frame: 30 and 90 days
Changes from baseline in the SARA (Scale for Assessment and Rating of Ataxia) scores
Time frame: 30 and 90 days
Changes from baseline in the speech intelligibility (percentage of intelligible words recorded during standardized passage reading)
Time frame: 30 and 90 days
Changes from baseline in QUEST (Quality of Life in Essential Tremor Questionnaire) scores
Time frame: 30 and 90 days
Change from baseline in the CRST (Clinical Rating Scale for Tremors)
Time frame: 30 and 90 days
Composite safety outcome of MRgFUS thalamotomy
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- 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. This study is not recruiting at the moment.
Nir Lipsman, MD, PhD principal investigator
Sunnybrook Health Sciences Centre
Agessandro Abrahao, MD, MSc principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis in people with Multiple Sclerosis, 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 9 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 21 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadia Scantlebury, PhD (416-480-6100 ext. 4390, nadia.scantlebury@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite safety outcome of MRgFUS thalamotomy (time frame: 90 days). 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 21 Feb 2020.