An interventional study of Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis in Multiple Sclerosis, sponsored by Sunnybrook Health Sciences Centre. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-02-21.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Device feasibility
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).
3,460 studies on the registry are indexed under Multiple Sclerosis; 660 are open to participants now.
This study's planned enrollment of 6 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 133 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will undergo MRgFUS thermal ablation of the ventral intermedius (Vim) thalamus contralateral to the most affected side of the body.
Device: Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis
The intervention is MRIgFUS thermal ablation of the ventral intermedius (Vim) thalamus contralateral to the most affected side of the body.
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
Time frame: 90 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre