NCT06543797尚未招募早期 1 期
A Prospective, Single-center, Single-group, Investigator-led Exploratory Clinical Trial to Determine the Safety of the Application of a Wearable Medical Electromagnetic Generator.
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Safety
研究概览
简要总结
To explore the safety of applying repetitive low-frequency transcranial magnetic stimulation using a wearable medical electromagnetic generator in stroke patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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
结局指标
主要结局
Safety
时间窗: Before and after 2 weeks of intervention / Soon after every intervention
All types of adverse events that occurred during clinical trials
次要结局
- Changes of geriatric depression scale (GDS-d)(Before and after 2 weeks of intervention)
- Changes of Evoked-potentials (EP)(Before and after 2 weeks of intervention)
- Changes of Fugl-Meyer assessment(Before and after 2 weeks of intervention)
- Changes of manual muscle test (MMT)(Before and after 2 weeks of intervention)
- Changes of box and block test (BBT)(Before and after 2 weeks of intervention)
- Changes of action research arm test (ARAT)(Before and after 2 weeks of intervention)
- Changes of Korean mini-mental state examination (K-MMSE)(Before and after 2 weeks of intervention)
- Changes of Korean version of Modified Barthel Index (K-MBI)(Before and after 2 weeks of intervention)
- Changes of electroencephalograpy (EEG)(Before and after 2 weeks of intervention)
- Changes of motion analysis(Before and after 2 weeks of intervention)
- Changes of functional near-infrared spectroscopy (fNIRS)(Before and after 2 weeks of intervention)
- Changes of blood biomarker(Before and after 2 weeks of intervention)
研究者
MinYoung Kim, MD, PhD
Principle investigator
Bundang CHA Hospital
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