The goal of this clinical trial is to investigate the efficacy and safety of vagus nerve stimulation (VNS) combined with rehabilitation in improving upper extremity motor function after spontaneous intracerebral hemorrhage (ICH).
Researchers will evaluate the efficacy and safety of VNS by comparing the improvements of arm motor function post-ICH in the active VNS combined rehabilitation group with that in the sham VNS combined rehabilitation group (actual intensity 0 mA).
Participants in this study will undergo a surgical procedure to implant the VNS system and will subsequently recieve a 6 weeks in-clinic therapy, followed by an additional 6 weeks home exercise. During the final 6 weeks, participants will either recieve in-clinic therapy or maintain their home exercise, depending on their assigned group.
Age ≥22 years and <80 years, all gender is acceptable.
History of unilateral supratentorial intracerebral hemorrhage ≥ 6 months but < 5 years.
Upper Extremity motor section of the Fugl-Meyer Assessment score ≥20 and ≤50.
Right- or left-sided weakness of upper extremity.
History of ischemic stroke.
Cerebral hemorrhage resulting from tumors, trauma, aneurysms, or hemorrhagic transformation of ischemic stroke.
Presence of ongoing dysphagia or aspiration difficulties.
Prior injury to vagus nerve, either bilateral or unilateral.
First Affiliated Hospital of Fujian Medical University
Lead sponsor
Beijing Pins Medical Co., Ltd
Collaborator