Blood Oxygen Level Dependent fMRI Navigation for Function Protection in Intracranial Arteriovenous Malformation Surgery: a Multicenter Prospective Randomized Controlled Single Blind Clinical Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- modified Ranking Scale
研究概览
简要总结
Little is known about the effect of fMRI navigation in the intracranial arteriovenous malformation surgery. The investigators aim to perform a multicenter prospective randomized single -blind clinical trial to assess the effect and safety of fMRI navigation in the brain arteriovenous malformation surgery.
详细描述
Intracranial arteriovenous malformations (AVMs) are congenital lesions that consist of multiple arteries and veins, connecting as a fistula without an intervening normal capillary bed. Surgical removal is thought as a major treatment option for AVMs. However, compared with stereotaxic radiosurgery and endovascular embolization, microsurgery of AVMs is regarded with high mortality and morbidity, particular for high level classification AVMs .
Blood oxygen level dependent fMRI can be used to mapping the motor and language regions of the brain noninvasively. It has been one of the most advanced functional imaging techniques and it has quickly grown to be a vital tool for clinical and cognitive neuroscience research. Many clinical researches have been reported about the utility of fMRI in brain tumor surgery. However, the effect of fMRI navigation for neurofunction protection in the intracranial arteriovenous malformation surgery was unclear.
We aim to perform a multicenter prospective randomized single -blind clinical trial to assess the safety and effect of fMRI navigation in the intracranial AVMs surgery. We hypothesize that application of blood oxygen level dependent fMRI is able to improve long term prognosis of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of intracranial AVM by DSA/CT/MRI
- •Age from 12-60 years
- •Be suitable for microsurgery treatment
- •All patients are able to cooperate with the fMRI examination
- •All patients gave written informed consent
排除标准
- •Patients with age < 12 years or > 60 years
- •Various conditions unable to meet the indications for microsurgery treatment
- •Intracranial hemorrhage need emergency surgery
- •Patients can not cooperate with fMRI examination
结局指标
主要结局
modified Ranking Scale
时间窗: six months after operation
The scale runs from 0-6, running from perfect health without symptoms to death. 0-No symptoms. 1. No significant disability. Able to carry out all usual activities, despite some symptoms. 2. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. Moderate disability. Requires some help, but able to walk unassisted. 4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. Dead.
次要结局
- Postoperative complications(six months after operation)
研究者
Dr. Yong Cao
MD
Beijing Tiantan Hospital