RecruitingNot ApplicableNCT07720882

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

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

Sponsor

NeuroXess Technology (shanghai) Co.,Ltd.

Enrollment

32 participants

Start Date

Jul 7, 2026

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injury

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria9

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 Criteria15

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;
Other ongoing medical interventions that may affect the benefit from BCI intervention (e.g., dependence on ventilator support, tracheostomy, nasogastric tube feeding, etc.);
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) ;
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;
Contraindications to surgery or anesthesia, or deemed unsuitable for implantation surgery by anesthesiology/surgical assessment;
Fever, or vital signs and/or intracranial status not yet stabilized;
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.;
Planned MRI examination during the device implantation period;
Life expectancy < 6 months (e.g., severe end-stage diseases);
Participation in other drug or medical device clinical trials within the past 1 month;
Pregnant or breastfeeding women;
Other conditions that, in the investigator's judgment, make the subject unsuitable for participation in this clinical trial.

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Interventions

DEVICE"Triple-F" BCI

Subjects will undergo implantation of the "Triple-F" BCI and receive standardized brain-computer interface training postoperatively, including training with brain-controlled pneumatic gloves. Follow-up visits will be scheduled at 1, 2, 3 and 6 months after implantation.