Status:
UNKNOWN
Feasibility Study of Transcranial Ultrasound Stimulation (TUS) on Stroke Patients
Lead Sponsor:
Cheng-Hsin General Hospital
Conditions:
Intracerebral Hemorrhage
Hemiplegia
Eligibility:
All Genders
20-65 years
Phase:
NA
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 clinic...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04877184
Start Date
July 8 2021
End Date
December 31 2024
Last Update
March 7 2023
Active Locations (1)
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1
Cheng-Hsin general hospital
Taipei, Taiwan