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

NCT07720882 | Recruiting DMC

• 1 other identifier: 2026-1015
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury

Keywords

BCI; Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• 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).

  3 months post-operation

Secondary Outcomes (10)

• The ARAT score assessed with BCI assistance

  2, 3, and 6 months post-operation

• ARAT score assessed without BCI assistance

  baseline, 3 and 6 months post-operation

• Task completion rate of five common hand-movement brain-control tasks

  baseline，2，3 and 6 months post-operation

• Success rate for six-direction target selection under brain control

  3 and 6 months post-operation

• Change from baseline in Activities of Daily Living (ADL) score as measured by the Barthel Index

  baseline,2， 3 and 6 months post-operation

Study Arms (1)

"Triple-F" BCI

EXPERIMENTAL

Experimental: Implantation of the "Triple-F" BCI

Device: "Triple-F" BCI

Interventions

"Triple-F" BCI DEVICE

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.

Also known as: Fully implanted, wireless and functional BCI

"Triple-F" BCI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NeuroXess Technology (shanghai) Co.,Ltd.: lead
• Huashan Hospital: collaborator

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Ying Mao, MD

CONTACT

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

Liang Chen, MD

CONTACT

hschenliang@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 22, 2026
• Study Start: July 7, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

CN (1)