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Not yet recruiting NCT06543797

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

Early Phase I Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: wearable rTMS.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 19 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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

Interventions

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

Primary outcome measures

  • Safety [Time frame: Before and after 2 weeks of intervention / Soon after every intervention]
Secondary outcome measures (12)
  • Changes of Fugl-Meyer assessment [Time frame: Before and after 2 weeks of intervention]
  • Changes of manual muscle test (MMT) [Time frame: Before and after 2 weeks of intervention]
  • Changes of box and block test (BBT) [Time frame: Before and after 2 weeks of intervention]
  • Changes of action research arm test (ARAT) [Time frame: Before and after 2 weeks of intervention]
  • Changes of Korean mini-mental state examination (K-MMSE) [Time frame: Before and after 2 weeks of intervention]
  • Changes of Korean version of Modified Barthel Index (K-MBI) [Time frame: Before and after 2 weeks of intervention]
  • Changes of geriatric depression scale (GDS-d) [Time frame: Before and after 2 weeks of intervention]
  • Changes of electroencephalograpy (EEG) [Time frame: Before and after 2 weeks of intervention]
  • Changes of Evoked-potentials (EP) [Time frame: Before and after 2 weeks of intervention]
  • Changes of motion analysis [Time frame: Before and after 2 weeks of intervention]
  • Changes of functional near-infrared spectroscopy (fNIRS) [Time frame: Before and after 2 weeks of intervention]
  • Changes of blood biomarker [Time frame: Before and after 2 weeks of intervention]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)
  • Exclusion criteria for repetitive transcranial magnetic stimulation
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06543797 · 2024-01-070

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗