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

Launched by XUANWU HOSPITAL, BEIJING · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new rehabilitation approach for people who have experienced spinal cord injuries (SCIs). The study combines two innovative therapies: spinal cord stimulation (a method that uses electrical signals to help regain movement) and robotic exoskeletons (wearable robots that assist with walking). By using these technologies together, the goal is to create personalized rehabilitation plans that can help restore movement in the legs and improve overall quality of life for patients.

To participate in this trial, individuals need to be between the ages of 14 and 65 and have a spinal cord injury that has impaired their ability to move their legs for at least six months. They should have been undergoing regular rehabilitation for at least one month but have not seen significant improvement in their motor function in the last two months. Participants can expect to engage in a structured rehabilitation program that includes both spinal cord stimulation and robotic assistance, with the hope of regaining some mobility. It's important for interested individuals to discuss their eligibility with their healthcare provider, as there are specific health conditions that may exclude them from participating.

Gender

ALL

Eligibility criteria

• 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 to trauma, inflammation, tumors, vascular diseases, iatrogenic factors, or other causes, confirmed through medical history, physical examination, and auxiliary tests;
• • Diagnosed with spinal cord injury for at least 6 months, undergoing continuous routine rehabilitation for at least 1 month (including but not limited to physical therapy, acupuncture, hydrotherapy, etc., with daily training time ≥ 3 hours), but with no significant improvement in motor function over the past 2 months;
• • Classified according to the ASIA impairment scale (AIS) based on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), with an impairment 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 informed consent form, demonstrates good compliance, and is willing to cooperate with follow-up assessments.
• Exclusion Criteria:
• • Suffering from other diseases affecting lower limb muscle function besides spinal cord injury, including brain diseases (such as brain tumors, stroke, etc.), lower limb vascular diseases (such as lower limb vascular occlusion), peripheral nerve diseases, 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, drug infusion pump, cochlear implant, sacral nerve stimulator, etc. (whether turned on or off);
• • Unable to undergo implantation of active devices due to treatment or examination requirements for other diseases;
• • Suffering from severe cardiovascular diseases: ischemic heart disease or myocardial infarction 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, or echocardiogram 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 intravenous antibiotics, antifungals, or antivirals) or soft tissue infection in the lumbar or back region, or unexplained fever \>38.5°C during screening or before surgery;
• • Human Immunodeficiency Virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active pulmonary tuberculosis, active hepatitis B (HBV DNA ≥500 IU/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA levels above the detection threshold), or co-infection with both hepatitis B and C;
• • Severe cerebrovascular events (including transient ischemic attacks, intracerebral hemorrhage, 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 prior to enrollment;
• • Presence of addictive behaviors such as drug abuse or alcoholism;
• • History of substance abuse of psychiatric drugs that cannot be discontinued, or presence of mental disorders;
• • Pregnant women, breastfeeding women, women planning pregnancy, or women of childbearing age without reliable contraception;
• • Presence of cognitive impairments or other factors preventing the patient from following treatment interventions and rehabilitation training;
• • Situations that increase the risk associated with participation in the study or the study devices, and other conditions judged by the investigator that would make the patient unsuitable for inclusion in the study.