Spinal cord injury
Conditions
Interventions
Experimental Group:Non?invasive Brain?Computer Interface Combined with Spinal Cord Stimulation and Exoskeleton Rehabilitation Therapy
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years (inclusive), regardless of gender; 2. Clinically diagnosed with spinal cord injury (caused by trauma, inflammation, tumor, vascular diseases, iatrogenic factors, etc.), with definite motor dysfunction of upper and/or lower extremities confirmed by medical history, physical examination and auxiliary examinations; 3. Complicated with complications meeting the routine clinical implantation indications for spinal cord stimulation (SCS), i.e., refractory neuropathic pain (disease duration >= 3 months, Visual Analogue Scale (VAS) score >= 5 points, with no response, poor efficacy or intolerance to side effects after standardized pharmacotherapy or conventional rehabilitation); 4. Diagnosed with spinal cord injury for >= 6 months; received continuous conventional rehabilitation training for >= 1 month after injury (including but not limited to physical therapy, acupuncture, hydrotherapy, etc., with daily training duration >= 3 hours), with no significant improvement in motor dysfunction in the past 2 months; 5. Classified as Grade A, B or C according to the ASIA Impairment Scale (AIS) of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). (Note: During actual subject recruitment and cohort enrollment, priority will be given to patients with ASIA Grade B and C with partial preservation of descending neural pathways.) 6. Mini-Mental State Examination (MMSE) score >= 22; 7. Educational level of middle school or above; 8. Subjects voluntarily participate in this study, sign informed consent forms, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Poor general health status with life expectancy =450 ms in males and >=470 ms in females); New York Heart Association (NYHA) grade III-IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) 1.5 ULN or PT>ULN+4 seconds or APTT>1.5 ULN), bleeding tendency, or receiving thrombolytic or anticoagulant therapy; 12. Severe infection (e.g., requiring intravenous antibiotics, antifungal or antiviral drugs) or lumbodorsal soft tissue infection within 4 weeks before surgery; unexplained fever>38.5? during screening or before surgery; any active infection or fever, or unstable vital signs; 13. 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 anti-HCV antibody with HCV-RNA above the lower limit of detection of the analytical method), or co-infection with hepatitis B and hepatitis C; 14. Severe cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, pulmonary embolism, etc., within 12 months before enrollment; 15. Metastatic malignant tumors or untreated malignant tumors; 16. Major surgery, severe traumatic injury, fracture or ulcer within 4 weeks before enrollment; 17. Addictive habits such as drug abuse or alcoholism; 18. History of psychotropic drug abuse that cannot be eliminated, or mental disorders with definite psychiatric diseases such as depressi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall clinical efficacy rate 6 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement Rate of Visual Analogue Scale (VAS) for Pain;Incidence of Adverse Events Related to Trial Devices;Overall Clinical Response Rate at 6?Month Post?operation; | — |
Countries
China
Contacts
Public ContactDuan Wanru
Xuanwu Hospital, Capital Medical University
Outcome results
None listed