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

NCT06543797 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 2024-01-070
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Safety

  All types of adverse events that occurred during clinical trials

  Before and after 2 weeks of intervention / Soon after every intervention

Secondary Outcomes (12)

• Changes of Fugl-Meyer assessment

  Before and after 2 weeks of intervention

• Changes of manual muscle test (MMT)

  Before and after 2 weeks of intervention

• Changes of box and block test (BBT)

  Before and after 2 weeks of intervention

• Changes of action research arm test (ARAT)

  Before and after 2 weeks of intervention

• Changes of Korean mini-mental state examination (K-MMSE)

  Before and after 2 weeks of intervention

Study Arms (1)

Stroke patients

EXPERIMENTAL

Device: wearable rTMS

Interventions

wearable rTMS DEVICE

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

Stroke patients

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Bundang CHA Hospital: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Minyoung Kim, M.D., Ph.D.

  Bundang CHA Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ye Ji Jeong, BS

CONTACT

+82 031 780 6003; a240283@chamc.co.kr

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 9, 2024
• Study Start: August 20, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share