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 Brainstem Stroke (Ischemic)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to 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 brainstem stroke
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 80
Healthy Volunteers: f
View:
• 19-80 years old
• Radiologically confirmed ischemic stroke with subcortical and brainstem lesions within 90 days
• Fugl-Meyer assessment scale (upper extremity) \> 15
• Mini-mental status exam (the Korean version) \> 14 with appropriate cognitive function
• Written informed consent
Locations
Other Locations
Republic of Korea
Department of Rehabilitation Medicine, Chungnam National University Hospital, Korea
NOT_YET_RECRUITING
Daejeon
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Contact Information
Primary
Won Kee Chang, MD
wonkee.chang@gmail.com
82-031-787-7739
Backup
Yeo Kyung Yoon
yyk97504@naver.com
82-031-787-7739
Time Frame
Start Date: 2023-01-02
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 88
Treatments
Experimental: real rTMS
Use the real rTMS coil
Sham_comparator: sham rTMS
Use the sham rTMS coil
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Bundang Hospital
Collaborators: Chungnam National University Hospital