Stroke
Conditions
Brief summary
To explore the safety of applying repetitive low-frequency transcranial magnetic stimulation using a wearable medical electromagnetic generator in stroke patients.
Interventions
DEVICEwearable rTMS
Application of inhibitory low-frequency rTMS on unaffected primary motor cortex by wearable rTMS
Sponsors
Bundang CHA Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 19 to 80 years old 2. Those who are confirmed to have lesions in only one cerebral hemisphere or one brainstem on brain computed tomography (CT) or brain magnetic resonance imaging (MRI) 3. Patients with subacute stroke between 2 weeks and less than 3 months after onset 4. Motor function evaluation The total score is 0 to 56 points based on the FMA of the upper extremity on the affected side \[1\], and patients show impairment in upper extremity motor function. 5. After receiving a detailed explanation of this clinical trial and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to comply with the precautions.
Exclusion criteria
1. Cases accompanied by existing serious neurogenic diseases such as history of underlying stroke, brain tumor, hypoxic brain injury, epilepsy, or organic brain disease 2. Cases accompanied by existing serious psychiatric diseases such as major schizophrenia, bipolar disorder, dementia, etc., that are receiving continuous drug treatment before the stroke. 3. Those with unstable conditions in the cardiovascular, digestive, respiratory, and endocrine systems, or with severe internal diseases such as signs of systemic infection, with unstable vital signs, or with poor overall health with a life expectancy of less than 1 year. 4. Those with impaired cognitive ability (MMSE less than 10 points) 5. If there are difficulties in conducting research 6. If you have difficulty communicating 7. Other patients who are deemed difficult to participate in this study by the principal investigator. 8. Patients who are participating in other therapeutic clinical studies or who have participated in other therapeutic clinical studies within the past 30 days (observational studies are not relevant) 9.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | Before and after 2 weeks of intervention / Soon after every intervention | All types of adverse events that occurred during clinical trials |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of manual muscle test (MMT) | Before and after 2 weeks of intervention | Manual muscle test for strength in score |
| Changes of box and block test (BBT) | Before and after 2 weeks of intervention | Box and block test for gross manual dexterity in number of blocks from on compartment of a box to another of equal size within 60 seconds |
| Changes of action research arm test (ARAT) | Before and after 2 weeks of intervention | Action research arm test for functional ability of upper extremity in score |
| Changes of Korean mini-mental state examination (K-MMSE) | Before and after 2 weeks of intervention | Korean mini mental state exam for cognitive function in score |
| Changes of Korean version of Modified Barthel Index (K-MBI) | Before and after 2 weeks of intervention | Korean version of modified barthel index for functional status in score |
| Changes of Fugl-Meyer assessment | Before and after 2 weeks of intervention | Fugl-Meyer assessment for motor function in score |
| Changes of electroencephalograpy (EEG) | Before and after 2 weeks of intervention | Electroenchphalography is a test that measures EEG power in alpha band |
| Changes of Evoked-potentials (EP) | Before and after 2 weeks of intervention | Evoked potential is an electrical potential recorded from the nervous system of a human or animal following presentation of a stimulus. In this study, motor- and sensory- evoked potentials are included. |
| Changes of motion analysis | Before and after 2 weeks of intervention | Motion analysis with motion capture setup and data processing or streaming of patients movements. In this study, data of motion capture include kinetic and kinematic data including physiological parameter. |
| Changes of functional near-infrared spectroscopy (fNIRS) | Before and after 2 weeks of intervention | Funtional near-infrared spectroscopy meausures cortical activity in concentration of oxy- and deoxy-hemoglobin |
| Changes of blood biomarker | Before and after 2 weeks of intervention | Blood biomarker include expression of tumor necrosis factor (TNF)-a and interleukin (IL)-1b |
| Changes of geriatric depression scale (GDS-d) | Before and after 2 weeks of intervention | Geriatric depression scale for depression in scale |
Contacts
Primary ContactYe Ji Jeong, BS
Outcome results
None listed