NCT02151175Enrolling By Invitation不适用
LIFUP for Treatment of Temporal Lobe Epilepsy
BrainSonix Inc.1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Absence of histological changes
研究概览
简要总结
We intend to use focused ultrasound to stimulate or suppress brain activity in patients with epilepsy. We hypothesize that focused ultrasound is capable of brain stimulation or suppression visible with functional MRI, and will not cause tissue damage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with clinical evidence from their diagnostic evaluations of unilateral hippocampal dysfunction and epileptogenicity.
- •Subjects with seizures that have been refractory to treatment with at least three currently marketed antiepileptic drugs.
- •Subjects with epilepsy who would clearly benefit from surgical intervention.
- •Subjects who have been offered a non-dominant anterior-mesial temporal lobe resection as treatment for medication refractory epilepsy.
排除标准
- •Subjects with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with the testing.
- •Subjects with dementia, delirium and psychotic symptoms. - Subjects with ferromagnetic materials in the head.
- •Subjects with severe cardiac disease, increased intracranial pressure, or a TENS unit.
- •Subjects who exhibit primary generalized seizures or pseudoseizures.
- •Subjects who have seizures secondary to drugs, alcohol, metabolic illness or progressive degenerative disease.
- •Subjects who have experienced status epilepticus during the 3-week baseline period prior to the operation.
- •Subjects (females) who are pregnant.
研究组 & 干预措施
LIFUP
Experimental
干预措施: LIFUP (Device)
结局指标
主要结局
Absence of histological changes
时间窗: 7 days
次要结局
- Beck Depression Inventory changes(1 day)
- Brief Symptom Inventory changes(1 day)
- Seizure frequency changes(6 days)
- Neuropsychiatric changes(1 day)
- Neurological changes(1 day)
研究者
研究点 (1)
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