Transcutaneous Auricular Vagus Nerve Stimulation in Spinal Cord Injury (taVNS)
Spinal Cord Injuries, Spinal Cord Diseases, Nervous System Diseases
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring gait, Vagus Nerve Stimulation
Eligibility Criteria
Inclusion Criteria: A diagnosis of traumatic complete/incomplete apar/teraplgia At least 12 months post-traumatic SCI Patient included in rehabilitation program After laparoscopic implantation of neurosprothesis to the pelvic nerves (LION procedure) Mini-mental State examination score>24 Stable medication Patient who voluntarily accept the test and sign an informed consent form Exclusion Criteria: There is a clear history of cerebrovascular stroke, and there are clear symptoms or signs of neurological deficit at the time of onset, and there are corresponding responsible lesions left on neuroimaging Patients with significant visual impairment or coexisting local or systemic diseases (eg osteoarthritis, or neuro,ogical conditions) likely to affect gait are excluded from the study Pathologies of the articulation and ligaments of the LE that make standing/walking anatomically impossible Patients who underwent deep brain stimulation surgery or those with an implanted cardiac pacemaker are excluded Those with history of alcoholism, or drug addiction, or neurological diseases that can cause cognitive impairment, such as brain injury, epilepsy, encephalitis, normal intracranial pressure hydrocephalus Suffering from systemic diseases that may lead to cognitive impairment (such as liver and kidney insufficiency, endocrine diseases, vitamin deficiency) Suffering from cardiac conductive dysfunctions or sleep apnea syndrome Participating in other drug clinical trials There are contraindications to head MRI Those who are deemed unsuitable to participate the trial by the investigator
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Active transcutaneous auricular vagus nerve stimulation
Sham transcutaneous auricular vagus nerve stimulation
PtaVNS, twice daily, 30 minutes each time over 6 months. Followed by 6 months home excercice program, physiotherapy twice a week, and continuous low frequency antidromic pelvic neuromodulation (CAPN).
Sham PtaVNS (fictive stimulation), twice daily, 30 minutes each time over 6 months. Followed by 6 months home excercice program, physiotherapy twice a week, and continuous low frequency antidromic pelvic neuromodulation (CAPN).