KCT0007808尚未招募未知
Multi-center, Prospective, Comparative, Randomized, Double blind, Superior, Pivotal study to compare and evaluate the efficacy and safety of Repetitive Transcranial Magnetic Stimulation applied with an Electromagnetic therapy stimulator 'ALTMS-A' for Upper-limb motor function recovery with the Sham control group for those who need Upper-limb Rehabilitation treatment for subcortical and brain stem stroke(ischemic)
Remed0 个研究点目标入组 88 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
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