A Pilot Clinical Trial Study to Determine the Safety of the Application of a Wearable Medical Electromagnetic Generator
- Conditions
- Stroke
- Interventions
- Device: wearable rTMS
- Registration Number
- NCT06543797
- Lead Sponsor
- Bundang CHA Hospital
- Brief Summary
To explore the safety of applying repetitive low-frequency transcranial magnetic stimulation using a wearable medical electromagnetic generator in stroke patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 10
Not provided
- Cases accompanied by existing serious neurogenic diseases such as history of underlying stroke, brain tumor, hypoxic brain injury, epilepsy, or organic brain disease
- Cases accompanied by existing serious psychiatric diseases such as major schizophrenia, bipolar disorder, dementia, etc., that are receiving continuous drug treatment before the stroke.
- 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.
- Those with impaired cognitive ability (MMSE less than 10 points)
- If there are difficulties in conducting research
- If you have difficulty communicating
- Other patients who are deemed difficult to participate in this study by the principal investigator.
- 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)
- Exclusion criteria for repetitive transcranial magnetic stimulation
- Patients with medical devices implanted in the body (e.g. pacemaker)
- When a metal object is inserted into the skull
- If there is a wound on the skin at the attachment site
- History of epilepsy
- If you have cervical pain or musculoskeletal disease
- Pregnant and lactating women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stroke patients wearable rTMS -
- Primary Outcome Measures
Name Time Method Safety Before and after 2 weeks of intervention / Soon after every intervention All types of adverse events that occurred during clinical trials
- Secondary Outcome Measures
Name Time Method Changes of geriatric depression scale (GDS-d) Before and after 2 weeks of intervention Geriatric depression scale for depression in scale
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 Fugl-Meyer assessment Before and after 2 weeks of intervention Fugl-Meyer assessment for motor function in score
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 electroencephalograpy (EEG) Before and after 2 weeks of intervention Electroenchphalography is a test that measures EEG power in alpha band
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