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

Launched by BUNDANG CHA HOSPITAL · Aug 5, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the safety of a new wearable device that uses low-frequency magnetic stimulation to help stroke patients. The goal is to see if this device can be safely used to improve motor function in patients who have had a stroke. To be eligible for the study, participants must be between 19 and 80 years old, have specific brain injuries identified through imaging tests like CT or MRI, and be in the subacute phase of stroke recovery—meaning it has been at least two weeks but less than three months since their stroke. Additionally, they should have some difficulty moving their affected arm.

If you or a loved one qualifies for this trial, you can expect to receive detailed information about the study before deciding to participate. It's important to know that people with certain serious health conditions or those who have had recent treatments may not be able to join. The study is not yet recruiting, but it aims to help understand how this new therapy might assist stroke recovery in the future.

Gender

ALL

Eligibility criteria

• • 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. Exclusion criteria for repetitive transcranial magnetic stimulation
• • 10. Patients with medical devices implanted in the body (e.g. pacemaker)
• • 11. When a metal object is inserted into the skull
• • 12. If there is a wound on the skin at the attachment site
• • 13. History of epilepsy
• • 14. If you have cervical pain or musculoskeletal disease
• • 15. Pregnant and lactating women