NCT02252380进行中（未招募）不适用
A Feasibility Clinical Trial of the Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for the Management of Treatment-Refractory Movement Disorders
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- InSightec
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Severity of Device and Procedure Related Complications
研究概览
简要总结
The proposed study is to evaluate the effectiveness of ExAblate Transcranial MRgFUS as a tool for creating a unilateral lesion in the Vim thalamus or the globus pallidus (GPi) in patients with treatment-refractory symptoms of movement disorders.
详细描述
The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided focused ultrasound thermal ablation of a designated area in the brain of patients suffering from movement disorder symptoms:
- FUS under MRI-guidance and MRI-based thermometry can be safely delivered to patients suffering from treatment-refractory movement disorders through an intact human skull with a low risk of transient adverse effects as evaluated during follow-up of up to 12-months.
- A pre-defined target volume inside the brain can be accurately ablated, as demonstrated on post-treatment MRI.
- Lesions generated with ExAblate Neuro will result in clinical effects that are similar to those seen with ablative procedures using other surgical techniques (e.g. RF procedure).
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, between 18 and 85 years, inclusive.
- •Subjects who are able and willing to give consent and able to attend all study visits.
- •A movement disorder symptom that has been deemed treatment-refractory by a movement disorder neurologist, including:
- •o akathisia, akinesia, athetosis, bradykinesia, chorea, dystonia, tremor, myoclonus, dyskinesia, spasms, tics
- •Medication-refractoriness as determined by an adequate dose and duration of standard movement disorders treatment as determined by a specialist neurologist (e.g. a trial of primidone and propranolol for ET)
- •Able to communicate sensations during the ExAblate Neuro treatment
- •Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
排除标准
- •Patients with unstable cardiac status including:
- •Unstable angina pectoris on medication
- •Patients with documented myocardial infarction within six months of protocol entry
- •Congestive heart failure requiring medication (other than diuretic)
- •Patients on anti-arrhythmic drugs
- •Severe hypertension (diastolic BP > 100 on medication)
- •Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- •History of abnormal bleeding and/or coagulopathy (including deep venous thrombosis)
- •Cerebrovascular disease (multiple CVA or CVA within 6 months)
- •Symptoms and signs of increased intracranial pressure (e.g. headache, nausea, vomiting, lethargy, and papilledema)
- •Untreated, uncontrolled sleep apnea
- •Active or suspected acute or chronic uncontrolled infection
- •History of intracranial hemorrhage
- •Individuals 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
- •Patients unable to communicate with the investigator and staff.
- •Presence of any other neurodegenerative disease like multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
- •Patients with a history of seizures within the past year
- •Patients with psychiatric illness that are not well controlled. Any presence of psychosis will be excluded.
- •Patients with risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter) or a documented coagulopathy
- •Patients with brain tumors
- •Any illness that in the investigator's opinion preclude participation in this study.
- •Pregnancy or lactation.
- •Patient is unable to provide his own consent for any reason.
- •Legal incapacity or limited legal capacity.
- •Patients who have DBS or a prior stereotactic ablation of the basal ganglia
- •History of immunocompromise, including patient who is HIV positive
- •Known life-threatening systemic disease
结局指标
主要结局
Severity of Device and Procedure Related Complications
时间窗: At the time of ExAblate procedure
Safety will be evaluated individually for each subject who is treated
次要结局
未报告次要终点
研究者
研究点 (4)
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