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

N/ARecruitingNCT07720882

NeuroXess Technology (shanghai) Co.,Ltd.32 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Spinal Cord Injury

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

BCI-assisted ARAT response rate (at 3 months postoperatively)

The proportion of subjects whose BCI-assisted ARAT score at 3 months postoperatively minus the baseline unassisted ARAT score at screening is ≥ the Minimal Clinically Important Difference (MCID).

Time frame: 3 months post-operation

Secondary Outcomes

The ARAT score assessed with BCI assistance

The subject, wearing the pneumatic glove paired with the BCI system, performs the four ARAT subscales (grasp, grip, pinch, and gross motor) sequentially per standard procedures, with each subscale score and the total ARAT score recorded.The unabridged scoring sheet is titled the "Action Research Arm Test Scoring Sheet" . It yields a minimum score of 0 and a maximum score of 57 per arm (19 items scored 0-3 each), with higher scores indicating better outcomes, that is, better arm motor status.

Time frame: 2, 3, and 6 months post-operation

ARAT score assessed without BCI assistance

The subject completes the assessment in accordance with the standard ARAT operating procedures without using the BCI-actuated pneumatic glove.The unabridged scoring sheet is titled the "Action Research Arm Test Scoring Sheet" . It yields a minimum score of 0 and a maximum score of 57 per arm (19 items scored 0-3 each), with higher scores indicating better outcomes, that is, better arm motor status.

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

The Activities of Daily Living (ADL) Scale, commonly known as the Barthel Index, is scored using its original, unabridged form titled the "Barthel Index" , which comprises 10 items covering basic self-care and mobility, yielding a minimum total score of 0 (complete dependence) and a maximum of 100, with higher scores indicating better outcomes-that is, greater independence in activities of daily living.

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

ISNCSCI are recorded on its standard worksheet titled the "International Standards for Neurological Classification of Spinal Cord Injury" (ASIA/ISNCSCI worksheet), in which sensory function is scored separately for light touch and pin prick (each ranging from a minimum of 0 to a maximum of 112 across 28 dermatomes bilaterally) and motor function is scored across 10 key muscle groups per side (yielding a total motor score from 0 to 100, with upper- and lower-extremity subscores of 0-50 each), with higher scores indicating better outcomes-that is, less neurological impairment after spinal cord injury.

Time frame: baseline, 2，3 and 6 months post-operation

Reliability of the device

Under standardized conditions (with the subject at rest and room temperature ), the number of well-functioning channels of the implanted device is evaluated and recorded, together with the mean, median, minimum, and maximum impedance of the well-functioning channels and their trends over time. Impedance trends over time are presented as line graphs. Channels with an impedance not exceeding 1 MΩ are classified as well-functioning.

Time frame: day of implantation，1,2,3 and6 months post-operation

Investigator-evaluated device operability performance

At the scheduled visits, the operating investigator rates the following performance items of the BCI compensation system using a pre-designed device performance evaluation form, graded on a four-level scale (excellent/good/fair/poor): signal acquisition stability, defined as the reliability and consistency of electrode signal recording; decoding response speed, defined as the latency from the generation of motor intention to the initiation of pneumatic glove movement; pneumatic glove output accuracy, defined as the degree of concordance between the movements actually performed by the glove and the decoded intentions; overall system stability, defined as the failure rate and system reliability during long-term use; wearing comfort and convenience, defined as the ease of donning the pneumatic glove and the subject's comfort while wearing it; and overall operational convenience, defined as the complexity of routine system operation and its user-friendliness.

Time frame: 3 and 6 months post-operation

Subject-reported evaluation of device use

Assessment method: A subject device-use satisfaction questionnaire is administered; at the scheduled visits, the investigator reads each questionnaire item aloud to the subject, the subject responds verbally, and the investigator records the answers verbatim . The investigator must not guide or suggest the subject's answers in any way, and upon completion must confirm with the subject that the recorded responses are consistent with his or her own opinions. The questionnaire covers the following dimensions, each scored on a 5-point Likert scale with the following criteria: 5 = very satisfied / very easy, 4 = satisfied / relatively easy, 3 = neutral / neutral, 2 = dissatisfied / relatively difficult, 1 = very dissatisfied / very difficult. The dimensions include: wearing comfort, defined as the comfort of wearing the pneumatic glove in daily use; donning and doffing convenience, defined as the ease of putting on and taking off the pneumatic glove independent.

Time frame: 3 and 6 months post-operation

Average time of device use per month

Time frame: 3 and 6 months post-operation

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts