NCT02289560已完成不适用
A Continued Access Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- InSightec
- 入组人数
- 61
- 试验地点
- 14
- 主要终点
- Number of Device and Procedure Related Adverse Events.
研究概览
简要总结
The objective of this prospective, multi site, single-arm study is to capture the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in patients with essential tremor (ET).
详细描述
This study is evaluating a new technique for performing Thalamotomy for tremor control. While current techniques have possible invasive or radiation effects, the use of ExAblate if totally non-invasive and without any radiation. After informed consent and screening, eligible subjects will be undergo an ExAblate treatment. All subjects will be followed at 1 day, 1 week, 1, 3, 6 and 12 months and for up to 5 years as directed by their doctor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Men and women, age 22 years and older
- •Subjects who are able and willing to give informed consent and able to attend all study visits
- •Subjects with a diagnosis of Essential Tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder
- •Subject exhibits a significant disability from their ET despite medical treatment
- •Subjects should be on a stable dose of all ET medications for 30 days prior to study entry
- •Subject is able to communicate sensations during the ExAblate Transcranial procedure
排除标准
- •Subjects with unstable cardiac status
- •Severe hypertension
- •Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- •Known intolerance or allergies to the MRI contrast agent including advanced kidney disease or severely impaired renal function
- •Significant claustrophobia that cannot be managed with mild medication
- •Current medical condition resulting in abnormal bleeding and/or coagulopathy
- •Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage
- •History of intracranial hemorrhage
- •History of multiple strokes, or a stroke within past 6 months
- •Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment
- •Are participating or have participated in another clinical trial in the last 30 days
- •Subjects unable to communicate with the investigator and staff
- •Subjects with a history of seizures within the past year
- •Subjects with brain tumors
结局指标
主要结局
Number of Device and Procedure Related Adverse Events.
时间窗: 5 Years post treatment
The cumulative sum of adverse events was followed through Year 5 of the study.
次要结局
- Tremor Motor Score - Clinical Rating Scale for Tremor (CRST) Part A (Upper Extremity) + Part B Scores Summed(Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment)
- Clinical Rating Scale for Tremor (CRST Part A) Posture Score Change From Baseline(Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment)
- Quality of Life in Essential Tremor Total (QUEST)(Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment)
- Clinical Rating Scale for Tremor Part C - Activities of Daily Living.(Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment)
研究者
研究点 (14)
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