The aim of this study is to determine the efficacy and safety of binaural synchronous vagus nerve regulation in the treatment of patients with sensory and motor dysfunction after cerebral infarction through a randomized controlled clinical study, and to provide high-quality evidence support for binaural synchronous vagus nerve regulation in the treatment of cerebral infarction.
Patients with first-episode ischemic stroke within 7 to 14 days of onset;
Be over 18 years old;
The skin at the irritated area remains intact;
The informed consent form has been signed.
Severe cognitive dysfunction (Mini-Mental State Examination≥19);
Peripheral limb movement limiting factors (fractures);
History of major neurological and mental disorders in the past;
Uncontrollable limb and facial muscle twitching, and spontaneous profuse sweating;
Parallel
transcutaneous auriculai vagus nerve stimulation
DeviceDuring bi-ear synchronous vagus nerve stimulation, the patient was positioned in a supine position. Two stimulating electrodes were placed bilaterally in the concha cymba and concha cavum of the ears. The patient received treatment for 30 minutes per session, once daily, 5 days per week, for a total of 4 weeks. Following each treatment session, the device was disinfected with 75% alcohol.
Motor function score
Motor function was evaluated using the Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA) .The assessment was performed three times. The minimum score for the Fugl-Meyer Assessment (FMA) is 0, and the maximum score is 226.A higher score on the FMA indicates better motor recovery/function and a lower level of motor impairment.
Overall functional score
Assess three times using the National Institutes of Health Stroke Scale. The maximum score on the scale is 42, and the minimum score is 0.Higher scores denote more severe stroke symptoms.
Transcranial Magnetic Stimulation combined with Electroencephalography（TMS-EEG）
Amplitude and latency of key TMS-evoked potential (TEP) components ( N100, P180, N200) recorded from specific scalp electrodes (Fz, Cz, Pz) following single-pulse TMS over the dorsolateral prefrontal cortex (DLPFC).
Sensory function score
Using the Eastern Michigan Neuropathy Symptom Score Assessment sensory scale for assessment, the lowest possible score is 0 and the highest is 100. A higher score indicates that the patient's neurological symptoms are more severe and that the degree of nerve damage is more apparent.
Cognitive function score
Using the Mini-Mental State Examination scale for assessment, the minimum score is 0 and the maximum score is 30. The higher the score, the better the cognitive function of the examinee, indicating a normal cognitive state.
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