Feasibility Study of Transcranial Ultrasound Stimulation (TUS) on Stroke Patients
1 other identifier
interventional
20
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2021
CompletedFirst Posted
Study publicly available on registry
May 7, 2021
CompletedStudy Start
First participant enrolled
July 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMarch 7, 2023
March 1, 2023
2.5 years
April 27, 2021
March 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Brain observation by image
The investigators would use Magnetic Resonance Image (MRI) to observe if there is brain atrophy, hemorrhage, or any other anatomical change in brain. Magnetic Resonance Angiography (MRA) would be used, too, to observe any change in intracerebral vessels or blood-brain barrier.
12 weeks
Secondary Outcomes (17)
Body weight
12 weeks
respiratory rate
12 weeks
blood pressure
12 weeks
heart rate
12 weeks
electrocardiogram
12 weeks
- +12 more secondary outcomes
Study Arms (2)
Transcranial ultrasound stimulation and rehabilitation
EXPERIMENTALThe investigators expect to enroll 10 people in the experimental group.
Rehabilitation
ACTIVE COMPARATORThe investigators expect to enroll 10 people in the control group.
Interventions
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)
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
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cheng-Hsin general hospital
Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2021
First Posted
May 7, 2021
Study Start
July 8, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
March 7, 2023
Record last verified: 2023-03