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| Name | Class |
|---|---|
| Multiple Sclerosis Society of Canada | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis | Device | The intervention is MRIgFUS thermal ablation of the ventral intermedius (Vim) thalamus contralateral to the most affected side of the body. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1, 7, 30, 90 and 120 days |
| Incidence and severity of adverse events related to MS disease relapse or progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadia Scantlebury, PhD | Contact | 416-480-6100 | 4390 | nadia.scantlebury@sunnybrook.ca |
| Name | Affiliation | Role |
|---|---|---|
| Nir Lipsman, MD, PhD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Agessandro Abrahao, MD, MSc | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D014202 | Tremor |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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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
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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. |
| 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. | 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. | 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. | 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. | 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. | 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 | 30 days |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |