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

Bundang CHA Hospital

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Stroke

Treatments: Device: wearable rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT06543797

2024-01-070

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Stroke patients

Experimental group

Treatment:

Device: wearable rTMS