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

NCT ID: NCT04877184

Last Updated: 2023-03-07

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-08

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intracerebral Hemorrhage Hemiplegia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Transcranial ultrasound stimulation and rehabilitation

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

Group Type EXPERIMENTAL

Transcranial ultrasound stimulation and rehabilitation

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Rehabilitation

Intervention Type DEVICE

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)

Intervention Type DEVICE

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)

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cheng-Hsin General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cheng-Hsin general hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Wen-Shin Song

Role: CONTACT

+886-2-28264400 ext. 2081

Facility Contacts

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Wen-Shin Song

Role: primary

+886-2-28264400 ext. 2081

Other Identifiers

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(785)109A-24

Identifier Type: -

Identifier Source: org_study_id

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