Feasibility Study of Transcranial Ultrasound Stimulation (TUS) on Stroke Patients

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    20
  • sponsor
    Cheng-Hsin General Hospital
Updated on 28 May 2021

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.

Details
Condition Hemiplegia, Cerebral Hemorrhage, intracerebral hemorrhage, intracerebral haemorrhage, hemorrhage cerebral, intracerebral hemorrhage (ich), cerebral bleeding
Treatment Rehabilitation, Transcranial ultrasound stimulation and rehabilitation
Clinical Study IdentifierNCT04877184
SponsorCheng-Hsin General Hospital
Last Modified on28 May 2021

Eligibility

Yes No Not Sure

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
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)
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