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Transcranial focused ultrasound (tFUS) can be used as a non-invasive brain neuromodulation technique. Low-intensity focused ultrasound has been demonstrated to be safe and have neuromodulatory effects on the cerebral cortex in healthy human and animal experiments.This study aims to investigate the effect of tFUS on cortical excitability for motor recovery in patients with stroke.
The study is a pilot study for feasibility, which aims to recruit 20 patients with subacute (within 3 months) stroke and unilateral hemiparesis. tFUS stimulation will be delivered to the primary motor cortex on the healthy side. The treatment protocol consists of once daily treatment for consecutive five tFUS sessions. The primary outcomes are defined as cortical excitability assessment in bilateral primary motor cortex, as well as safety analysis; the secondary outcome measures include the Fugl-Meyer Assessment, Medical Research Council score, National Institutes of Health Stroke Scale (NIHSS), Barthel Index, Modified Rankin Scale and functional brain activities. The evaluation will be conducted before treatment and on the first day, first week, fourth week, and twelfth week after completing tFUS.
The second part of this study is an efficacy investigation, which plans to recruit 30 subacute stroke patients for a randomized controlled trial with a parallel-group design. The experimental group will receive focused ultrasound stimulation with the same parameters and target site as the Phase I pilot study, while the control group will receive sham stimulation at the same location. The treatment frequency will be the same as that of the pilot study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with tFUS | Experimental | Treatment with tFUS |
|
| Control | Sham Comparator | No ultrasound energy, only the background music will be played. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NaviFUS® Neuronavigation-guided focused ultrasound system | Device | The treatment protocol consists of once daily treatment for consecutive five tFUS sessions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-related Adverse Events | Includes rate of minor (scalp pain, headache, short-term dizziness, nausea, vomiting, short-term weakness, short-term numbness) and severe adverse events (seizure, persistent new onset weakness, documented new intracranial hemorrhage or infarction, death) | Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions. |
| Cortical excitability | The amplitude and latency of maximal MEP, rMT in bilateral primary motor cortex will be assessed. | Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment-Upper Extremity | The Fugl-Meyer Assessment for upper extremity is a standardized tool used to assess motor recovery after stroke. It consists of four items: shoulder/elbow/forearm, wrist, hand, and coordination. Each item is scored individually, with scores ranging from 0 to 2 depending on the quality of the movement. The total score ranges from 0 to 66, with higher scores indicating better motor function and recovery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meng Ting Lin, M.D. | Contact | +886-2312-3456 | 67048 | b96401093@ntu.edu.tw |
| Ming Yen Hsiao, M.D. | Contact | +886-2312-3456 | 67651 | myferrant@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Meng Ting Lin, M.D. | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| NaviFUS® Neuronavigation-guided focused ultrasound system | Device | No ultrasound energy will be delivered (Mechanical Index, MI = 0); only the background music will be played (During each treatment session, the background music will be presented in the same way as in the experimental group during the operation of the focused ultrasound system). All other stimulation settings and procedures will be identical to those used in the experimental group |
|
| Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions. |
| Medical Research Council score | The Medical Research Council (MRC) score is a simple and widely used scale to assess muscle strength. It rates muscle strength on a scale from 0 to 5, with 0 being no muscle contraction and 5 being normal muscle strength. | Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions. |
| National Institutes of Health Stroke Scale (NIHSS) | The National Institutes of Health Stroke Scale (NIHSS) is a standardized tool used to assess the severity of a stroke and its effects on patients. It evaluates various neurological functions, such as consciousness, movement, sensation, and language, assigning scores ranging from 0 to 42, with higher scores indicating more severe stroke symptoms. | Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions. |
| Barthel Index | The Barthel Index is a measure of a person's ability to perform activities of daily living. It assesses functions such as feeding, bathing, grooming, dressing, bowel and bladder control, toileting, transfers, mobility, and stairs. The score ranges from 0 to 100, with higher scores indicating greater independence. | Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions. |
| Modified Rankin Scale | The Modified Rankin Scale is a widely used tool to assess a patient's level of disability after a stroke or other neurological disorders. It measures the degree of disability or dependence in daily activities, with scores ranging from 0 (no symptoms) to 6 (death). | Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions. |
| Functional brain activities | Functional brain activities were detected by fNIRS (NIRSport2 NIRx Medical Technologies LLC, Glen Head, NY, USA). The subjects were requested to perform functional task (unilateral hand grasping), and brain activities was recorded by fNIRS in the following brain regions: bilateral premotor cortices, supplementary motor area, M1 and primary somatosensory cortices. The ΔHbO2 signal will be analyzed using the HOMER2 fNIRS analysis software. | Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |