A Second Magnetic Resonance Guided Focused Ultrasound Thalamotomy for Essential Tremor
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|ClinicalTrials.gov Identifier: NCT04720469|
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
This study will be a single-centre, prospective, single-arm, open-label, 12-week pilot trial assessing the safety and preliminary efficacy of a second MR-guided focused ultrasound (MRgFUS) thalamotomy on the naïve brain hemisphere after 48 weeks or more of the first MRgFUS thalamotomy in patients with medication-refractory ET.
This study will be conducted at the Focused Ultrasound Centre of Excellence at Sunnybrook Health Sciences Centre/University of Toronto.
|Condition or disease||Intervention/treatment||Phase|
|Essential Tremor||Device: MRgFUS thalamotomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-arm, pre/post designl study|
|Masking:||None (Open Label)|
|Masking Description:||This study is open label. CRST rating will be performed by a trained neurologist who will be blinded to whether the CRST data were collected pre- or post- treatment.|
|Official Title:||A Safety Pilot Clinical Trial of a Second Magnetic Resonance Guided Focused Ultrasound (MRgFUS) Thalamotomy for the Management of Medication-refractory Essential Tremor|
|Actual Study Start Date :||October 5, 2020|
|Estimated Primary Completion Date :||October 31, 2022|
|Estimated Study Completion Date :||October 31, 2023|
Experimental: Patients with bilateral essential tremor who have undergone one MRgFUS thalamotomy
Patients with bilateral essential tremor who have undergone one MRgFUS thalamotomy
Device: MRgFUS thalamotomy
Ablation of untreated thalamus using focused ultrasound to abate tremor.
Other Name: ExAblate Neuro
- Incidence at week 12 of new onset or significant worsening of: ataxic gait; speech impairment; cognitive impairment; contralateral weakness; patient-reported disabling sensory loss; Severe AEs related to the MRgFUS procedure. [ Time Frame: 12 weeks ]This composite outcome will be measured by the Scale for the Assessment and Rating of Ataxia (SARA) scale, neuropsychology battery, neurological examination and AE reports.
- Change in the tremor score (Part A and B) from baseline to 12 weeks after MRgFUS thalamotomy, adjusted for baseline scores. [ Time Frame: 12 weeks ]This CRST subscore will be measured on the treated side.
- Change in QUEST global score and EQ-5D from baseline to 12 weeks after MRgFUS, adjusted for baseline scores. [ Time Frame: 12 weeks ]QUEST (Quality of Life in Essential Tremor) is a disease-specific quality of life scale.
- Change in speech intelligibility and speaking rate from baseline to 12 weeks after MRgFUS thalamotomy, adjusted for baseline scores. [ Time Frame: 12 weeks ]Speech intelligibility is measured as the percentage of intelligible words and speaking rate is measured as words per minute.
- Change in the subscores of neuropsychological tests and self-reported questionnaires from baseline to 12 weeks after MRgFUS thalamotomy. [ Time Frame: 12 weeks ]Alternative versions of the neuropsychological tests and self-reported questionnaires of cognitive function will be used in the baseline and week 12 visit to account for a learning effect.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04720469
|Contact: Nadia Scantlebury, PhD||416-480-6100 ext firstname.lastname@example.org|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Nadia Scantlebury, PhD 416-480-6100 ext 4390 email@example.com|
|Principal Investigator:||Agessandro Abrahao, MD, MSc||Sunnybrook Health Sciences Centre|