Rehabilitation Combining Spatiotemporal Spinal Cord Stimulation and Real-time Triggering Exoskeleton After Spinal Cord Injury

Inclusion Criteria:

• Aged between 14 and 65 years, with no restriction on gender;

• Diagnosed with spinal cord injury resulting in lower limb motor impairment due totrauma, inflammation, tumors, vascular diseases, iatrogenic factors, or othercauses, confirmed through medical history, physical examination, and auxiliarytests;

• Diagnosed with spinal cord injury for at least 6 months, undergoing continuousroutine rehabilitation for at least 1 month (including but not limited to physicaltherapy, acupuncture, hydrotherapy, etc., with daily training time ≥ 3 hours), butwith no significant improvement in motor function over the past 2 months;

• Classified according to the ASIA impairment scale (AIS) based on the InternationalStandards for Neurological Classification of Spinal Cord Injury (ISNCSCI), with animpairment grade of A, B, or C;

• Generally in good health, with an expected life expectancy of ≥ 12 months;

• The subject voluntarily agrees to participate in the study, signs an informedconsent form, demonstrates good compliance, and is willing to cooperate withfollow-up assessments.

Exclusion Criteria:

• Suffering from other diseases affecting lower limb muscle function besides spinalcord injury, including brain diseases (such as brain tumors, stroke, etc.), lowerlimb vascular diseases (such as lower limb vascular occlusion), peripheral nervediseases, lower limb bone diseases (such as osteoarthritis, joint contractures,etc.);

• Congenital or acquired abnormalities in lower limb skeletal or muscular structure;

• Presence of surgical contraindications (such as adverse reactions to anesthesia,bleeding risks, or when the surgeon deems the patient unsuitable for surgery);

• Presence of active implanted devices, such as a pacemaker, defibrillator, druginfusion pump, cochlear implant, sacral nerve stimulator, etc. (whether turned on oroff);

• Unable to undergo implantation of active devices due to treatment or examinationrequirements for other diseases;

• Suffering from severe cardiovascular diseases: ischemic heart disease or myocardialinfarction of class II or higher, uncontrolled arrhythmias (including QTc interval ≥450 ms for males or ≥470 ms for females); heart failure of NYHA class III-IV, orechocardiogram showing left ventricular ejection fraction (LVEF) <50%;

• Coagulation dysfunction (INR >1.5 ULN or PT >ULN +4 seconds or APTT >1.5 ULN),bleeding tendency, or currently receiving thrombolytic or anticoagulant therapy;

• Severe infection within 4 weeks prior to surgery (such as requiring intravenousantibiotics, antifungals, or antivirals) or soft tissue infection in the lumbar orback region, or unexplained fever >38.5°C during screening or before surgery;

• Human Immunodeficiency Virus (HIV) infection or known acquired immunodeficiencysyndrome (AIDS), active pulmonary tuberculosis, active hepatitis B (HBV DNA ≥500IU/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA levels above thedetection threshold), or co-infection with both hepatitis B and C;

• Severe cerebrovascular events (including transient ischemic attacks, intracerebralhemorrhage, or ischemic stroke), deep vein thrombosis, or pulmonary embolism within 12 months prior to enrollment;

• Presence of metastatic malignant tumors or untreated malignant tumors;

• Major surgery or severe traumatic injury, fractures, or ulcers within 4 weeks priorto enrollment;

• Presence of addictive behaviors such as drug abuse or alcoholism;

• History of substance abuse of psychiatric drugs that cannot be discontinued, orpresence of mental disorders;

• Pregnant women, breastfeeding women, women planning pregnancy, or women ofchildbearing age without reliable contraception;

• Presence of cognitive impairments or other factors preventing the patient fromfollowing treatment interventions and rehabilitation training;

• Situations that increase the risk associated with participation in the study or thestudy devices, and other conditions judged by the investigator that would make thepatient unsuitable for inclusion in the study.