Neuromodulation for Functional Recovery After Stroke

This study used a multicenter, double-blind, randomized controlled design. The trial protocol was jointly designed by the principal investigator and an executive committee composed of experts in functional neurosurgery, cerebrovascular disease, and rehabilitation medicine. The study enrolled patients in the subacute phase (3-6 months) after ischemic stroke with upper limb motor impairment. All patients were implanted with a vagus nerve stimulation (VNS) device and randomly assigned to an active VNS (0.8 mA) group combined with upper limb rehabilitation or a control VNS (0.0 mA) group. This study used the FMA-UE score, WMFT score, and other measures to assess changes in impairment severity. The primary endpoint was the difference in FMA-UE score between the active VNS group and the control group at the end of 6 weeks of hospital treatment. Secondary endpoints included changes from baseline in FMA-UE score and WMFT score at 90 days, among others. This study evaluates the safety and efficacy of vagus nerve stimulation for improving upper limb motor function in patients in the subacute phase after stroke, ultimately providing clinical evidence for the diagnosis and treatment of this patient population.

Inclusion Criteria: 1. History of unilateral supratentorial ischemic stroke and in the subacute phase (3-6 months); 2. Age between 18-80 years, both male and female; 3. FMA-UE score of 20-50 (inclusive); 4. Ability to communicate, understand, and provide appropriate consent; participant can follow two-step commands; 5. Right or left upper limb weakness; 6. Active flexion/extension of the wrist or fingers; 7. Informed consent signed by the patient or a family member. Exclusion Criteria: 1. History of hemorrhagic stroke; 2. Persistent dysphagia or choking/coughing while eating or drinking; 3. Medications that, at study initiation, may significantly interfere with the effects of VNS on neurotransmitter systems; 4. Prior vagus nerve injury, bilateral or unilateral (e.g., injury during carotid endarterectomy); 5. Severe or more severe depression (Beck Depression Inventory \>29); 6. Candidates unsuitable for device implantation surgery (e.g., history of adverse reaction to anesthesia, deemed unsuitable as a surgical candidate by the surgeon, etc.); 7. Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug; 8. Preexisting neurological or psychiatric disorders before stroke onset that affect assessment of the condition; 9. Pregnancy, planned pregnancy, or breastfeeding during the study period; 10. Severe upper limb spasticity (modified Ashworth ≥3); 11. Severe sensory loss. Sensory loss will be measured using the upper extremity sensory portion of the Fugl-Meyer Assessment. The assessment involves light touch (two items) and proprioception (four items). The maximum score is 12; subjects with a score below 6 will be excluded from the study; 12. Other conditions that the investigator considers unsuitable for participation or that may pose a significant risk to the patient.