The Efficacy & Safety of rTMS for Upper-limb Motor Function Recovery in Subcortical and Brainstem Stroke

Launched by SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL · Sep 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called repetitive transcranial magnetic stimulation (rTMS) to see if it can help people recover movement in their arms after having a stroke that affects certain areas deep in the brain. The treatment uses a special device called 'ALTMS-A' to send gentle magnetic pulses to the brain, which may help improve arm function. The study compares this treatment to a fake (sham) version to find out if it really works and is safe.

People who might join the study are adults between 19 and 80 years old who have had a specific type of stroke within the last three months, affecting parts of the brain that control movement, and who still have some ability to move their arm. Participants need to be mentally able to understand and take part in the study and agree to it in writing. Those with other types of brain injury, previous strokes, or medical conditions that could affect safety or results won’t be eligible. If you join, you’ll receive regular treatment sessions and physical therapy, and the study team will carefully check your progress and any side effects. This study is currently looking for volunteers who fit these criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Fugl-Meyer assessment scale (wrist) \< 1 or Fugl-Meyer assessment scale (hand) \< 1
• • Hemorrhagic stroke or traumatic brain injury
• • Cerebellar stroke
• • Previous history of stroke
• • Traumatic brain injury
• • Previous history of brain surgery
• • Need for intensive care due to complications associated with stroke (e.g. pneumonia, infection, hemodynamic instability)
• • History of psychological or neurological diseases
• • History of pain or muscular weakness of upper limbs which may interfere with rehabilitation
• • History of seizure or epilepsy
• • Aphasia
• • Skin lesions in the stimulation site of scalp
• • Intracranial metal implant
• • Inability to receive regular physical or occupational therapy
• • Disagreement to use contraception in women of childbearing age