A Pilot Clinical Trial Study to Determine the Safety of the Application of a Wearable Medical Electromagnetic Generator

Официальное название

A Prospective, Single-center, Single-group, Investigator-led Exploratory Clinical Trial to Determine the Safety of the Application of a Wearable Medical Electromagnetic Generator.

Обзор

To explore the safety of applying repetitive low-frequency transcranial magnetic stimulation using a wearable medical electromagnetic generator in stroke patients.

Вмешательства

• Устройство wearable rTMS
  Application of inhibitory low-frequency rTMS on unaffected primary motor cortex by wearable rTMS

Первичные конечные точки

• Safety [Срок оценки: Before and after 2 weeks of intervention / Soon after every intervention]

Вторичные конечные точки (12)

• Changes of Fugl-Meyer assessment [Срок оценки: Before and after 2 weeks of intervention]
• Changes of manual muscle test (MMT) [Срок оценки: Before and after 2 weeks of intervention]
• Changes of box and block test (BBT) [Срок оценки: Before and after 2 weeks of intervention]
• Changes of action research arm test (ARAT) [Срок оценки: Before and after 2 weeks of intervention]
• Changes of Korean mini-mental state examination (K-MMSE) [Срок оценки: Before and after 2 weeks of intervention]
• Changes of Korean version of Modified Barthel Index (K-MBI) [Срок оценки: Before and after 2 weeks of intervention]
• Changes of geriatric depression scale (GDS-d) [Срок оценки: Before and after 2 weeks of intervention]
• Changes of electroencephalograpy (EEG) [Срок оценки: Before and after 2 weeks of intervention]
• Changes of Evoked-potentials (EP) [Срок оценки: Before and after 2 weeks of intervention]
• Changes of motion analysis [Срок оценки: Before and after 2 weeks of intervention]
• Changes of functional near-infrared spectroscopy (fNIRS) [Срок оценки: Before and after 2 weeks of intervention]
• Changes of blood biomarker [Срок оценки: Before and after 2 weeks of intervention]

Критерии участия

Критерии включения

• Patients aged 19 to 80 years old
• 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)
• Patients with subacute stroke between 2 weeks and less than 3 months after onset
• 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.
• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06543797 · 2024-01-070

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗