Clinical trial NCT04877184: Feasibility Study of Transcranial Ultrasound Stimulation (TUS) on Stroke Patients
Official title: Feasibility Study of Transcranial Ultrasound Stimulation (TUS) on Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracerebral Hemorrhage
Hemiplegia
Lead sponsor: Cheng-Hsin General Hospital
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Brain observation by image
timeFrame: 12 weeks
Secondary outcomes:
measure: Body weight
timeFrame: 12 weeks
measure: respiratory rate
timeFrame: 12 weeks
measure: blood pressure
timeFrame: 12 weeks
measure: heart rate
timeFrame: 12 weeks
measure: electrocardiogram
timeFrame: 12 weeks
measure: Serum biomarkers: trophic factors
timeFrame: 12 weeks
measure: Serum biomarkers: factors relating inflammatory response
timeFrame: 12 weeks
measure: Serum biomarkers: neurodegeneration
timeFrame: 12 weeks
measure: Device and procedure related adverse events recording
timeFrame: 12 weeks
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 12 weeks
measure: Stroke Rehabilitation Assessment of Movement (STREAM)
timeFrame: 12 weeks
measure: Fugl-Meyer Assessment (FMA)
timeFrame: 12 weeks
measure: Wolf Motor Function test (WMFT)
timeFrame: 12 weeks
measure: Berg Balance Scale (BBS)
timeFrame: 12 weeks
measure: Timed up-and-go test
timeFrame: 12 weeks
measure: Barthal index
timeFrame: 12 weeks
measure: World Health Organization Quality of Life (WHOQOL-BREF)-Taiwan version
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cheng-Hsin general hospital
Study officials:
References: