Study on the safety and efficacy of upper extremity motor function recovery after neuromodulatory stimulation using low-intensity focused ultrasound (NS-US200) in patients with ischemic stroke
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0008320
- Lead Sponsor
- Korea University Anam Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 12
1) Adult men and women aged 19 or older but less than 85
2) Patients diagnosed with supratentorial stroke through brain MRI due to their first ischemic stroke, which can affect upper limb function by invading the cortical or subcortical area of the brain, regardless of the occurrence mechanism of ischemic strokes, such as thrombotic, embolic, or lacunar stroke, According to the Korean Clinical Practice Guidelines for Stroke Rehabilitation, repetitive transcranial magnetic stimulation (rTMS) is recommended to improve upper-limb function after stroke rehabilitation. But it isn't clear who should use rTMS or how well it works for stroke rehabilitation based on where the lesion is or what caused the stroke. Caution should be used because there are some risks and side effects. Low-intensity focused ultrasound stimulation is considered valid for stroke patients with lesions affecting upper limb function. This is because it is hard to find a single cause for a stroke, and previous studies and guidelines have focused on the functional impairment of upper-limb function rather than the location of the lesion.
3) Patients in the subacute phase, within three months of an ischemic stroke, based on the screening time, which is when the maximum neural plasticity of the brain occurs after a stroke.
4) Patients with persistent hemiparetic motor impairment due to ischemic stroke at the time of screening: specifically, patients who are evaluated to have muscle weakness at the trunk or proximal part of the affected upper limb with a grade of 4 (good grade) or less according to the manual muscle test performed by a physical therapist are targeted.
º 0 grade: no muscle contraction
º 1 grade: visible or palpable muscle contraction, but the joint movement is impossible
º 2 grade: active joint movement in a gravity-free state
º 3 grade: active joint movement against gravity
º 4 grade: active joint movement against gravity and some resistance
º 5 grade: active normal joint movement against gravity and full resistance
5) Patients who have clear consciousness, are able to cooperate with the study, and have voluntarily agreed to participate in this clinical trial.
1.Patients with grade 5 upper limb muscle strength without significant upper limb muscle weakness after a stroke.
2.Pregnant or breastfeeding women (if a woman of childbearing potential has a positive urine HCG test).
3.Patients with abnormalities of the cerebral hemisphere or a history of cerebral disorders, including cerebrospinal fluid stenosis, brain tumors, abscesses, hydrocephalus, trauma, skull fractures, or congenital brain malformations, observed on brain imaging tests (CT or MRI), other than ischemic stroke.
4.Patients who have undergone baseline blood tests, including the following ranges: ? Kidney disease (creatinine> 2.0 mg/dL) ? Thrombocytopenia (less than 100 x 103/µL) ? Leukopenia (less than 4.0 x 103/µL) ? Liver disease (AST, ALT, total bilirubin values are more than twice the upper limit of the normal range)
5.Uncontrollable cardiac disease patients (unstable congestive heart failure, myocardial infarction, ventricular tachycardia, or third-degree atrioventricular block)
6.Patients with a history of contact dermatitis or sensitive skin abnormalities.
7.Patients with implanted electronic medical devices such as pacemakers that prevent magnetic resonance imaging (MRI) scanning.
8.Patients with a history of epilepsy, Parkinson's disease, agoraphobia, or other psychiatric disorders.
9.Patients who have a history of taking or are currently taking drugs that affect the peripheral or central nervous system for purposes other than improving cognitive function after a stroke.
10.Patients with the unstable general condition due to current infectious diseases such as fever.
11.Patients who require stable hemostasis after various surgeries, etc. In addition, in cases where participation in this clinical trial is deemed inappropriate at the discretion of the investigator.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fugl-Meyer score
- Secondary Outcome Measures
Name Time Method 1) Changes in radiological evaluation (MRI, DTI, fMRI), 2) Other clinical evaluations, 3) Electrophysiological function evaluations