What is the "Triple-F" BCI studying for spinal cord injury?

The study is evaluating a fully implanted wireless brain-computer interface designed to restore hand function in adults with tetraplegia due to spinal cord injury. Researchers aim to assess the safety and effectiveness of this device in helping patients regain upper-limb control. The trial is sponsored by NeuroXess Technology (Shanghai) Co., Ltd.

Who may be eligible for this spinal cord injury clinical trial?

Adults aged 18 to 65 years with cervical spinal cord injury at levels C2 to C6 and severe hand function impairment may be eligible. Participants must have stable condition for at least 6 months after injury and possess adequate cognitive and sensory abilities. Please review eligibility criteria for more details.

Is there any cost to participate in this spinal cord injury clinical trial?

Study-related care, including the implantable device and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 65Years

All Genders

ID07720882

Study of a Wireless Brain-Computer Interface to Restore Hand Function in Adults with Tetraplegia from Spinal Cord Injury Evaluating Safety and Clinical Benefit

Led by NeuroXess Technology (shanghai) Co.,Ltd. · Updated on 2026-07-22

Participants Needed

Research Sites

12 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating an implantable brain-computer interface BCI system designed to restore upper-limb function in adults with tetraplegia caused by spinal cord injury. This prospective, multicenter, single-arm clinical trial aims to assess the safety and clinical effectiveness of this device as a functional replacement for hand motor control. Participants will receive implantation of the Triple-F BCI device, followed by standardized brain-computer training including the use of brain-controlled pneumatic gloves. After implantation, follow-up visits will be conducted at 1, 2, 3, and 6 months to monitor progress and device performance. During the study, participants will undergo assessments using various scales and tests to evaluate hand function and device reliability. These include the ARAT score with and without BCI assistance, task completion rates for brain-controlled hand movements, and measures of daily living activities and neurological status. Device operability and user experience will also be evaluated throughout the follow-up period, which lasts up to 6 months post-implantation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years

All Genders

Eligibility Criteria

You may qualify if you...

Ages 18 to 65 years, male or female
Cervical spinal cord injury at levels C2 to C6 with ASIA Impairment Scale grade A, B, or C
Severe hand function impairment on the target upper limb with finger flexor muscle strength less than grade 3
ARAT scores: at least 2 for "hand to mouth", at least 1 for "hand to top of head" and "hand to back of head", and 1 or less for grasp, grip, and pinch tasks
Normal motor-related brain function with no acute cerebral changes
At least 12 months since injury with stable condition for 6 months and available rehabilitation records
Good cognitive function with MMSE score 22 or higher and MoCA score 26 or higher
Basic visual, auditory, and language abilities to cooperate with training
Voluntary participation and willingness to comply with examinations and follow-up visits

You will not qualify if you...

Neurodegenerative diseases, tumor-related secondary injury, or severe autonomic dysreflexia
Intracranial lesions or contraindications to brain implantation, including epilepsy, cerebrovascular disease, brain tumors, traumatic brain injury, metal implants, or other implant contraindications
Malignancies in other organs
Severe cardiovascular diseases like cardiac insufficiency, arrhythmias, or uncontrolled hypertension
Ongoing medical interventions affecting BCI benefits such as ventilator dependence or feeding tubes
Psychiatric disorders interfering with participation, including depression (HAMD ≥18) or anxiety (HAMA ≥14)
Active infections or severe coagulation abnormalities
Contraindications to surgery or anesthesia or deemed unsuitable for implantation
Fever or unstable vital signs or brain status
Upper-limb motor dysfunction from other causes like ALS, syringomyelia, muscular dystrophy, or nerve injuries
Planned MRI during implantation period
Life expectancy less than 6 months
Participation in other clinical trials within the past month
Pregnant or breastfeeding women
Other conditions judged unsuitable by investigators

Research Team

Ying Mao, MD

Liang Chen, MD

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