A Prospective, Long-term Analysis of Clinical Outcomes in Patients Undergoing Magnetic Resonance-Guided Focused Ultrasound for Medication-Refractory Tremor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change in tremor severity measured by Clinical Rating Scale for Tremor (CRST)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in tremor severity measured by Clinical Rating Scale for Tremor (CRST)
时间窗: 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.
次要结局
- Standardized Neurological Examination and Adverse Events (AEs)(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(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)(Assessments occur at baseline; Day 1; Week 12; and at 1, 2, and 3-year follow-up visits post-treatment.)
- Change in MRI Measures(Assessments occur at baseline; Day 1; Week 12; and at 1-, 2-, and 3-year follow-up visits post-treatment.)
研究者
Dr. Nir Lipsman
Principal Investigator
Sunnybrook Health Sciences Centre