Status:
NOT_YET_RECRUITING
A Pilot Clinical Trial Study to Determine the Safety of the Application of a Wearable Medical Electromagnetic Generator
Lead Sponsor:
Bundang CHA Hospital
Conditions:
Stroke
Eligibility:
All Genders
19-80 years
Phase:
EARLY_PHASE1
Brief Summary
To explore the safety of applying repetitive low-frequency transcranial magnetic stimulation using a wearable medical electromagnetic generator in stroke patients.
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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.
- Exclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
August 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06543797
Start Date
August 20 2024
End Date
December 31 2024
Last Update
August 9 2024
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