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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Cheng-Hsin general hospital

Taipei, Taiwan