Feasibility Study of Transcranial Ultrasound Stimulation (TUS) on Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Brain observation by image
研究概览
简要总结
Currently, the main treatment method for Intracerebral Hemorrhage (ICH) is medication or surgery. However, the effectiveness of medicines is moderate and there are several side effects. In this clinical trial, we would like to enhance the protein levels of brain derived neurotrophic factor in the brain by the transcranial ultrasound stimulation (TUS). By this technology, the symptoms of ICH could be alleviated and the side effects of medicines might be avoided. Preclinical trials have also shown that low-intensity pulsed ultrasound can alleviate the degree of neuroinflammation, neurodegeneration and significantly improve motor and cognitive deficits after brain injury. The purpose of this clinical trial is to evaluate the safety and feasibility of TUS for the treatment of patients with hypertensive intracerebral hemorrhage. The primary safety assessment indexes are brain magnetic resonance imaging (MRI) and brain magnetic resonance angiography (MRA). The secondary safety assessment indexes include weight, vital signs, electrocardiogram, general blood biochemical tests, adverse reaction events, and concurrent drug tracking. The feasibility assessment includes blood specific biomarker expression and neurological function & quality of life scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 65 years old
- •hemiplegia or hemiparesis
- •has a history of hypertension
- •a victim of first episode of hypertensive intracerebral hemorrhage at basal ganglion
- •3 to 12 months after the episode of hypertensive intracerebral hemorrhage
- •medically stable
- •the blood flow of middle cerebral artery (M1) could be detected by transcranial doppler
排除标准
- •severe heart failure (New York Heart Association class 4)
- •severe angina pectoris (canadian cardiovascular society class 4)
- •chronic kidney disease stage 5
- •hepatic encephalopathy stage 2 or more advanced
- •uncontrolled diabetes mellitus in recent 6 months (HbA1c > 8.5)
- •combined with intraventricular hemorrhage causing hydrocephalus and underwent ventriculoperitoneal shunt placement surgery
- •high-dose radiation exposure in recent 1 year
- •blood flow of middle cerebral artery (M1) could be not be detected by transcranial doppler at either side
- •major psychological disease in recent 6 months (for example, uncontrolled depression, schizophrenia, and bipolar disease)
- •has evidence of any autoimmune disease, neurodegenerative disease (such as parkinsonism, Alzheimer's disease), or epilepsy
- •has clinically significant systemic disease or severe infection (pneumonia, sepsis)
- •pregnant or lactating women
- •allergy to MRI contrast
- •uncontrolled hypertension (systolic blood pressure higher than 160 mmHg or diastolic blood pressure higher than 100 mmHg) transcranial doppler
- •aneurysm, brain tumor, or arteriovenous malformation identified by MRA
- •has coagulation disorders or other coagulation problems identified by blood test (abnormal complete blood count, prothrombin time, or partial thromboplastin time)
结局指标
主要结局
Brain observation by image
时间窗: 12 weeks
The investigators would use Magnetic Resonance Image (MRI) to observe if there is brain atrophy, hemorrhage, or any other anatomical change in brain. Magnetic Resonance Angiography (MRA) would be used, too, to observe any change in intracerebral vessels or blood-brain barrier.
次要结局
- heart rate(12 weeks)
- Serum biomarkers: trophic factors(12 weeks)
- Body weight(12 weeks)
- electrocardiogram(12 weeks)
- blood pressure(12 weeks)
- respiratory rate(12 weeks)
- Serum biomarkers: factors relating inflammatory response(12 weeks)
- Stroke Rehabilitation Assessment of Movement (STREAM)(12 weeks)
- Wolf Motor Function test (WMFT)(12 weeks)
- Serum biomarkers: neurodegeneration(12 weeks)
- National Institutes of Health Stroke Scale (NIHSS)(12 weeks)
- Berg Balance Scale (BBS)(12 weeks)
- Barthal index(12 weeks)
- Device and procedure related adverse events recording(12 weeks)
- Fugl-Meyer Assessment (FMA)(12 weeks)
- Timed up-and-go test(12 weeks)
- World Health Organization Quality of Life (WHOQOL-BREF)-Taiwan version(12 weeks)