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

Official title

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

Overview

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.

Detailed description

This trial adopts a prospective, multicenter, single-arm target value study design.

All enrolled subjects will receive implantation of an implantable brain-computer interface system for compensatory hand motor function, followed by standardized brain-computer training (including brain-controlled pneumatic gloves). Follow-up assessments will be conducted at 1, 2, 3 and 6 months after implantation to evaluate the safety and efficacy of the investigational medical device for upper-limb functional replacement in patients with tetraplegia caused by spinal cord injury.

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.

Primary outcome measures

• BCI-assisted ARAT response rate (at 3 months postoperatively) [Time frame: 3 months post-operation]

Secondary outcome measures (10)

• The ARAT score assessed with BCI assistance [Time frame: 2, 3, and 6 months post-operation]
• ARAT score assessed without BCI assistance [Time frame: baseline, 3 and 6 months post-operation]
• Task completion rate of five common hand-movement brain-control tasks [Time frame: baseline，2，3 and 6 months post-operation]
• Success rate for six-direction target selection under brain control [Time frame: 3 and 6 months post-operation]
• Change from baseline in Activities of Daily Living (ADL) score as measured by the Barthel Index [Time frame: baseline,2， 3 and 6 months post-operation]
• Change from baseline in the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) score [Time frame: baseline, 2，3 and 6 months post-operation]
• Reliability of the device [Time frame: day of implantation，1,2,3 and6 months post-operation]
• Investigator-evaluated device operability performance [Time frame: 3 and 6 months post-operation]
• Subject-reported evaluation of device use [Time frame: 3 and 6 months post-operation]
• Average time of device use per month [Time frame: 3 and 6 months post-operation]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

China · 1 center

• Huashan Hospital — Shanghai

Identifiers

NCT: NCT07720882 · 2026-1015

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗