Clinical trial NCT06543797: A Pilot Clinical Trial Study to Determine the Safety of the Application of a Wearable Medical Electromagnetic Generator
Official title: A Prospective, Single-center, Single-group, Investigator-led Exploratory Clinical Trial to Determine the Safety of the Application of a Wearable Medical Electromagnetic Generator.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Stroke
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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

Primary outcomes:
measure: Safety
timeFrame: Before and after 2 weeks of intervention / Soon after every intervention
Secondary outcomes:
measure: Changes of Fugl-Meyer assessment
timeFrame: Before and after 2 weeks of intervention
measure: Changes of manual muscle test (MMT)
timeFrame: Before and after 2 weeks of intervention
measure: Changes of box and block test (BBT)
timeFrame: Before and after 2 weeks of intervention
measure: Changes of action research arm test (ARAT)
timeFrame: Before and after 2 weeks of intervention
measure: Changes of Korean mini-mental state examination (K-MMSE)
timeFrame: Before and after 2 weeks of intervention
measure: Changes of Korean version of Modified Barthel Index (K-MBI)
timeFrame: Before and after 2 weeks of intervention
measure: Changes of geriatric depression scale (GDS-d)
timeFrame: Before and after 2 weeks of intervention
measure: Changes of electroencephalograpy (EEG)
timeFrame: Before and after 2 weeks of intervention
measure: Changes of Evoked-potentials (EP)
timeFrame: Before and after 2 weeks of intervention
measure: Changes of motion analysis
timeFrame: Before and after 2 weeks of intervention
measure: Changes of functional near-infrared spectroscopy (fNIRS)
timeFrame: Before and after 2 weeks of intervention
measure: Changes of blood biomarker
timeFrame: Before and after 2 weeks of intervention
Other outcomes:
Locations:
Study officials:
affiliation: Bundang CHA Hospital
name: Minyoung Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: