A Clinical Study of a Fully Implanted, Wireless and Functional BCI for Upper-Limb Functional Replacement in Tetraplegia Due to Spinal Cord Injury: Efficacy and Safety

Trial details

Who runs it

NeuroXess Technology (shanghai) Co.,Ltd.

Trial code

NCT07720882

Record updated

22 July 2026

Original description

This prospective, multicenter, single-arm clinical trial will enroll subjects with tetraplegia secondary to spinal cord injury. An implantable brain-computer interface system for compensatory hand motor function will be used to reconstruct upper-limb function, so as to evaluate the safety and clinical efficacy of this device in achieving upper-limb functional replacement.Read full original descriptionShow less

A Prospective, Multicenter, Single-Arm Target Value Clinical Trial to Evaluate the Efficacy and Safety of Implantable Brain-Computer Interface Hand Motor Function Compensation System for Upper-Limb Functional Replacement in Tetraplegic Patients With Spinal Cord Injury

This prospective, multicenter, single-arm clinical trial will enroll subjects with tetraplegia secondary to spinal cord injury. An implantable brain-computer interface system for compensatory hand motor function will be used to reconstruct upper-limb function, so as to evaluate the safety and clinical efficacy of this device in achieving upper-limb functional replacement.

Inclusion: 18 years ≤ age ≤ 65 years, male or female; Cervical spinal cord injury (injury level C2-C6), with ASIA Impairment Scale grade A, B, or C; Severe impairment of hand function on the target upper extremity: finger flexor muscle strength < grade 3 as assessed by the ISNCSCI scale; ARAT score ≥ 2 for "hand to mouth"; score ≥ 1 for both "hand to top of head" and "hand to back of head"; and scores ≤ 1 for each of the grasp, grip, and pinch tasks; Neurological assessment confirms normal motor-related cortical function of the brain, with no acute cerebral functional changes; At least 12 months have elapsed since the cervical spinal cord injury resulting in tetraplegia, and the condition has been stable for at least 6 months following standardized treatment (with documentation of rehabilitation therapy records available); Good cognitive function: Mini-Mental State Examination (MMSE) score ≥ 22 and Montreal Cognitive Assessment (MoCA) score ≥ 26 ; Possess the basic visual, auditory, and language comprehension abilities required for interaction, and be able to cooperate with training; The subject voluntarily participates and is willing to comply with the relevant examinations and follow-up visits.

Exclusion: Contraindications to surgery or anesthesia, or deemed unsuitable for implantation surgery by anesthesiology/surgical assessment; Participation in other drug or medical device clinical trials within the past 1 month; Neurodegenerative diseases / secondary injury due to tumors, or severe autonomic dysreflexia; Presence of intracranial lesions or contraindications to intracranial implantation: active epilepsy or definite epileptogenic tendency; severe cerebrovascular disease; brain tumor; moderate-to-severe sequelae of traumatic brain injury; space-occupying lesions or structural abnormalities at the electrode implantation target area; already implanted with active implantable electronic devices such as cardiac pacemakers/defibrillators, cochlear implants, deep brain stimulators, or drug infusion pumps, or presence of local metal foreign bodies/implants in the area to be implanted; or other contraindications to intracranial implantation as assessed by the investigator; Malignancies in other organ systems; Cardiovascular system diseases: severe cardiac insufficiency, severe arrhythmias, or uncontrolled hypertension; Presence of psychiatric or psychological disorders that may interfere with the subject's participation in BCI training, such as depression (HAMD ≥ 18 points) or anxiety disorder (HAMA ≥ 14 points) ; Upper-limb motor dysfunction due to other etiologies, such as amyotrophic lateral sclerosis, syringomyelia, spinal vascular diseases, muscular dystrophy, hypokalemic periodic paralysis, spondylitis, arthritis, osteomyelitis, peripheral nerve injury, tendon rupture, etc; Life expectancy < 6 months (e.g., severe end-stage diseases); Other conditions that, in the investigator's judgment, make the subject unsuitable for participation in this clinical trial; Presence of active infection; severe coagulation abnormalities (activated partial thromboplastin time (APTT) or prothrombin time (PT) > 2.5 × upper limit of normal); or other severe systemic diseases that, as assessed by the investigator, may significantly increase surgical risk or interfere with neurological function assessment or system use; Other ongoing medical interventions that may affect the benefit from BCI intervention (e.g., dependence on ventilator support, tracheostomy, nasogastric tube feeding, etc.); Fever, or vital signs and/or intracranial status not yet stabilized; Planned MRI examination during the device implantation period; Pregnant or breastfeeding women.

ClinicalTrials.gov NCT07720882