None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : Experiment group: Low-frequency rTMS
Control group: Sham rTMS
Sponsors
Remed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults between the ages of 19 and 80 2. Patients with an imaging diagnosis with an initial onset of subcortical and brainstem stroke (ischemic) within 90 days of the screening visit 3. Those with a score of more than 15 on the Fugl-Meyer Assessment Scale (Upper Extremity) 4. K-Mini Mental Status Exam (K-MMSE) A person who has enough cognitive ability to understand and follow the instructions of the examiner with a score of 15 or higher 5. Women of childbearing age who have agreed to use one or more of the clinically appropriate methods of contraception during the trial period. 6. Those who voluntarily decided to participate in this clinical trial and agreed in writing to the subject's explanation and consent form 7. A person who is willing to comply with the clinical trial protocol
Exclusion criteria
Exclusion criteria: 1. Among the Fugl-Meyer Assessment Scale (Upper Extremity) scores, those with a wrist score less than 1 and a hand score less than 1. 2. Those diagnosed with hemorrhagic stroke 3. Those diagnosed with cerebellar-involving stroke 4. Persons diagnosed with recurrent stroke 5. Persons diagnosed with stroke due to traumatic brain injury 6. Those with a history of cerebrovascular surgery 7. Those who require intensive treatment due to serious complications due to stroke 8. Persons with a history of psychiatric or neurological diseases before the onset of stroke 9. Those who had a disease causing pain or muscle atrophy that prevented the rehabilitation of the upper extremity before the onset of stroke 10. Those with a history of epilepsy or seizure disorders 11. Those who cannot communicate due to aphasia 12. Those with skin lesions in the area to be stimulated 13. A person who has inserted a metal material into the cranial cavity (pacific pacemaker, cerebral aneurysm clip, etc.). However, it is possible for those who have inserted metal materials that are not affected by magnetic fields such as artificial joints and spinal implants. 14. Those who cannot regularly receive physical and occupational therapy for paralyzed upper limbs 15. Those who are currently participating in other clinical trials or have experience participating in other clinical trials within 90 days from the screening date 16. In other cases, when the investigator judges that participation in the clinical trial is inappropriate because it may affect the clinical trial results or ethically
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Box and Block Test (BBT) Number of Changes (pcs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Assessment Scale (Upper Extremity) score change (points);Korean version modified Barthel Index (K-mBI) score change (points);NIH Stroke Scale (NIHSS) score change (points);Finger tapping score change (points);Brunnstrom Stage step change;modified Ashworth Scale (MAS) score change (points);Grip Strength (Hand grip, Pinch grip, Lateral prehension, Three jaw chuck) change (lbs) | — |
Countries
Korea, Republic of
Contacts
Public ContactWon Kee Chang
Seoul National University Bundang Hospital
Outcome results
None listed