RecruitingNot Applicable

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

China32 participantsStarted 2026-07-07

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 3 months post-operation

Trial details

NCT IDNCT07720882

SponsorNeuroXess Technology (shanghai) Co.,Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01-30

Contact for this trial

Ying Mao, MD

+86 021 5288 8045 maoying@fudan.edu.cn

View on ClinicalTrials.gov More Spinal Cord Injury trials