Feasibility Study of Transcranial Ultrasound Stimulation (TUS) on Stroke Patients
NCT ID: NCT04877184
Last Updated: 2023-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-07-08
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Transcranial ultrasound stimulation and rehabilitation
The investigators expect to enroll 10 people in the experimental group.
Transcranial ultrasound stimulation and rehabilitation
The participants in experimental group would received transcranial ultrasound stimulation and rehabilitation therapy.
* transcranial ultrasound stimulation: during 4 weeks
* rehabilitation: physiotherapy and occupational therapy (may combine with speech therapy and psychological therapy if needed)
Rehabilitation
The investigators expect to enroll 10 people in the control group.
Rehabilitation
The participants in control group would received rehabilitation therapy.
\- rehabilitation: physiotherapy and occupational therapy (may combine with speech therapy and psychological therapy if needed)
Interventions
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Transcranial ultrasound stimulation and rehabilitation
The participants in experimental group would received transcranial ultrasound stimulation and rehabilitation therapy.
* transcranial ultrasound stimulation: during 4 weeks
* rehabilitation: physiotherapy and occupational therapy (may combine with speech therapy and psychological therapy if needed)
Rehabilitation
The participants in control group would received rehabilitation therapy.
\- rehabilitation: physiotherapy and occupational therapy (may combine with speech therapy and psychological therapy if needed)
Eligibility Criteria
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Inclusion Criteria
* 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 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)
20 Years
65 Years
ALL
No
Sponsors
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Cheng-Hsin General Hospital
OTHER
Responsible Party
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Locations
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Cheng-Hsin general hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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(785)109A-24
Identifier Type: -
Identifier Source: org_study_id
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