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

Cheng-Hsin General Hospital

Status: Enrolling

Conditions: Intracerebral Hemorrhage; Hemiplegia

Treatments: Device: Rehabilitation; Device: Transcranial ultrasound stimulation and rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04877184

(785)109A-24

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Transcranial ultrasound stimulation and rehabilitation

Experimental group

Description:

The investigators expect to enroll 10 people in the experimental group.

Treatment:

Device: Transcranial ultrasound stimulation and rehabilitation

Rehabilitation

Active Comparator group

Description:

The investigators expect to enroll 10 people in the control group.

Treatment:

Device: Rehabilitation