Overview

The goal of this clinical trial is to evaluate the safety and technical feasibility of a novel brain-machine interface (BCI)-assisted spinal cord stimulation (SCS) and exoskeleton (EXS) system in patients with spinal cord injury (SCI). The primary aim is to determine whether the BCI-SCS-EXS system can safely and effectively improve lower limb motor function and quality of life in individuals with chronic SCI.

Participant Population:

Adults aged 14-65 years (sex/gender not limited). Patients with chronic SCI (≥6 months post-injury) classified as ASIA A, B, or C.

Individuals with stable health status, MMSE ≥22, and secondary education or above.

Primary Questions:

1. Is the BCI-SCS-EXS system safe and technically feasible for SCI rehabilitation?
2. Does the system improve lower limb motor function and quality of life in SCI patients?

   Interventions

Participants will undergo the following procedures:

Phase I (Implantation):

BCI implantation: ECoG electrodes placed over the motor cortex to decode lower limb movement intent.

SCS electrode implantation: 5-6-5 paddle electrodes at T11-L2 for targeted spinal cord stimulation.

Phase II (System Calibration):

BCI-SCS synchronization: Calibration of decoded motor intent to trigger SCS parameters.

SCS-EXO synchronization: Integration of SCS pulses with exoskeleton-assisted gait training.

Phase III (Rehabilitation):

Daily BCI-SCS-EXS training sessions (60 minutes, 5 times/week for 1 year). Adaptive adjustments to stimulation parameters and exoskeleton support based on performance.

Remote monitoring of device performance and emergency intervention for technical issues.

Outcome Measures:

Primary: Safety (adverse events, device performance, synchronization metrics). Secondary: Efficacy (motor function, neurophysiological function, quality of life).

Ethics and Safety:

Informed consent will be obtained from all participants. Adverse events will be monitored and reported according to CTCAE 5.0 guidelines.

Participant confidentiality will be strictly maintained. This study will provide foundational evidence for the safety and feasibility of the BCI-SCS-EXO system, paving the way for future randomized controlled trials in SCI rehabilitation.

Eligibility

Inclusion Criteria:

• Age 14-65 years, any gender.
• Clinical diagnosis of spinal cord injury (SCI) due to trauma, inflammation, tumor, vascular disease, or iatrogenic factors, confirmed by medical history, physical examination, and ancillary tests, resulting in lower limb motor dysfunction.
• SCI diagnosed ≥6 months prior, with ≥1 month of continuous conventional rehabilitation (e.g., physical therapy, acupuncture, hydrotherapy, ≥3 hours daily) without significant improvement in motor function in the past 2 months.
• ASIA Impairment Scale (AIS) grade A, B, or C based on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).
• Good general health with a life expectancy ≥12 months.
• Mini-Mental State Examination (MMSE) score ≥22.
• Educational attainment of secondary school or above.
• Willingness to participate, provide informed consent, and comply with study follow-up.

Exclusion Criteria:

• Presence of diseases other than spinal cord injury (SCI) that affect lower limb motor function, including brain diseases (e.g., brain tumor, stroke), lower limb vascular diseases (e.g., lower limb vascular occlusion), peripheral nerve diseases, or lower limb bone diseases (e.g., osteoarthritis, joint contracture).
• Requires continuous medical interventions (e.g., tracheal intubation, nasogastric feeding) to maintain critical physiological functions (e.g., heartbeat, respiration, swallowing).
• Congenital or acquired structural abnormalities of the lower limb bones or muscles.
• Presence of surgical contraindications (e.g., anesthesia-related adverse reactions, coagulation risks, or surgeon's determination of unsuitability for surgery).
• Presence of active implantable devices except for SCS or BCI devices (e.g., pacemakers, defibrillators, drug infusion pumps, cochlear implants, sacral nerve stimulators).
• Unable to receive implantable devices due to other disease treatments or investigations, or requires magnetic resonance imaging (MRI) during the device implantation period.
• MRI shows structural damage >50% in motor function areas (precentral and postcentral gyri, ventromedial sensorimotor areas, mid temporal lobe, Broca's area, Wernicke's area, Geschwind's area), or DTI shows damage >50% in the posterior limb of the internal capsule.
• Severe cardiovascular disease: Above level II myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QTc interval ≥450 ms in men, ≥470 ms in women), level III-IV heart failure (NYHA classification), or echocardiography showing LVEF <50%.
• Coagulation abnormalities (INR >1.5 ULN, PT >ULN +4 s, or APTT >1.5 ULN), hemorrhagic tendency, or undergoing thrombolytic or anticoagulant therapy.
• Severe infections within 4 weeks before surgery (requiring IV antibiotics, antifungals, or antivirals) or lumbar soft tissue infections, or unexplained fever >38.5℃ during screening or before surgery.
• HIV infection, acquired immunodeficiency syndrome (AIDS), active tuberculosis, active hepatitis B (HBV DNA ≥500 IU/ml), hepatitis C (positive HCV antibody and detectable HCV-RNA), or co-infection of hepatitis B and C.

Severe cerebrovascular events (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, or pulmonary embolism within 12 months before enrollment.

• Metastatic malignancies or untreated malignant tumors.
• Major surgery or severe traumatic injuries, fractures, or ulcers within 4 weeks before enrollment.
• Addictive habits such as drug abuse or alcoholism.
• History of psychotropic drug abuse that is not controllable or presence of mental disorders, including major psychiatric illnesses (e.g., depression [BDI score >20], anxiety, obsessive-compulsive disorder, schizophrenia, autism, chronic sleep disorders, consciousness disorders).
• Pregnant, breastfeeding, planning to conceive, or women of childbearing potential without reliable contraception.
• Participation in other clinical trials within the past month.
• Cognitive impairments or poor compliance from subjects, family members, or caregivers, or inability to complete at least 12 months of follow-up and rehabilitation training.
• Other conditions that increase the risk of study participation or device use, as determined by the investigator.