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

As a safety parameter, the investigators would follow up body weight (in kilograms) of the subjects, to observe if there is a tendency to rise or descend.

As a safety parameter, the investigators would follow up respiratory rate (in times per minute) of the subjects, to observe if there is a tendency to rise or descend.

As a safety parameter, the investigators would follow up blood pressure (in millimeter of mercury, mmHg) of the subjects, to observe if there is a tendency to rise or descend.

As a safety parameter, the investigators would follow up heart rate (in times per minute) of the subjects, to observe if there is a tendency to rise or descend.

As a safety parameter, the investigators would follow up electrocardiogram of the subjects, to observe if some newly-onset pathological evidences occur. For example, ST segment elevation, ST segment dumping, Q wave, or left bundle branch block could be pathological findings.

The investigators would measure serum brain-derived neurotrophic factor (BDNF) and serum vascular endothelial growth factor (VEGF) as the indicators as trophic factors. The changes of these biomarkers during the study would be evaluated.

The investigators would measure matrix metalloproteinase-9, S100 calcium-binding protein B, glial fibrillary acidic protein, and Interleukin, as the factors relating inflammatory response. The changes of these biomarkers during the study would be evaluated.

The investigators would measure phosphorylated Tau, and β-amyloid, as the indicators of neurodegeneration. The changes of these biomarkers during the study would be evaluated.

Rate of adverse events following each treatment through end of study clinical evaluation

National Institutes of Health Stroke Scale (NIHSS) is an objective scale for neurologic impairment of stoke. This scale includes 13 categories, with highest score of 3 or 4 and lowest score is 0, quantifying level of consciousness, best gaze, visual filed, facial palsy, motor function, limb ataxia, sensory function, language function, dysarthria, extinction/inattention. The maximum score is 42, which signifies severe stroke, while the minimum score is 0, meaning a normal exam.

Stroke Rehabilitation Assessment of Movement (STREAM) evaluate the recovery of voluntary movement and mobility post stroke in supine, sitting, and standing posture. It is composed of 30 items, measuring the upper limb voluntary movement, lower limb voluntary movements and basic mobility. A 3 point original scale (0~2) is used for upper and lower limb voluntary movement, and a 4 point original scale (0~3) is used for basic mobility. Higher scales means better motor performance.

The Fugl-Meyer Assessment (FMA) assesses motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The investigators chose the domain of motor score for this study. The motor score ranges from 0 (hemiplegia) to 100 points (normal motor performance). Divided into 66 points for upper extremity and 34 points for the lower extremity.

It is a 17-item measure used to quantify upper extremity functional limitations. It is comprised of 2 strength items and 15 timed task performance items, and the investigators choose the 15 timed task performance items for this study. The test yields 3 scores: a functional ability (FA) score, which quantifies quality of performance; a timed (time) score, quantifying speed of performance in seconds; and a grip strength (strength) score. The FA score uses a 6-point ordinal scale to rate movement quality on 15 items, where 0 indicates no attempt to use the more affected upper extremity and 5 indicates that movement of the affected upper extremity appears to be normal. The time score is the mean time to complete the same 15 items; scores were truncated at 120 seconds.

Berg balance scale determines a patient's ability to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.

Time up-and-go test assesses a person's mobility and requires both static and dynamic balance. During this test, a person should stand up from a chair and walk for 3 meters, turns around and walks back to the chair and sit down. The spent time was recorded.

The Barthel Index measures a person's performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently. The Barthel Index consists of 10 items of mobility and self care ADL.

The World Health Organization Quality of Life (WHOQOL-BREF) is a 28-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environmental health (9 items); with another 2 items about general condition and overall quality of life. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. The higher scores equals better quality of life.