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

NCT ID: NCT06543797

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-20
• Study Completion Date: 2024-12-31

Brief Summary

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

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Stroke patients

Group Type: EXPERIMENTAL

wearable rTMS

Intervention Type: DEVICE

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

Interventions

wearable rTMS

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

Intervention Type: DEVICE

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)

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bundang CHA Hospital

OTHER

Sponsor Role: lead

Responsible Party

MinYoung Kim, MD, PhD

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Minyoung Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Bundang CHA Hospital

Central Contacts

Ye Ji Jeong, BS

Role: CONTACT

a240283@chamc.co.kr

+82 031 780 6003 ext. 6003

Other Identifiers

2024-01-070

Identifier Type: -

Identifier Source: org_study_id