Implantable Wireless Brain-Computer Interface Systems in Patients With Tetraplegia
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07784088, who can take part
Where in China
- Beijing Tiantan Hospital,Capital Medical UniversityBeijing, ChinaContact: Wang Jia, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- BCIFlex Medical Technology Co., Ltd.
- Trial code
- NCT07784088
- Record updated
- 25 August 2026
- Original description
Objectives of Study: This trial aims to evaluate the safety and efficacy of an implantable wireless brain-computer interface system in patients with tetraplegia resulting from spinal cord injury.Read full original descriptionShow less
A Prospective, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of Implantable Wireless Brain-Computer Interface Systems in Patients With Tetraplegia
Objectives of Study: This trial aims to evaluate the safety and efficacy of an implantable wireless brain-computer interface system in patients with tetraplegia resulting from spinal cord injury.
Inclusion: Age ≥18 years and ≤65 years, male or female; Tetraplegia due to C2-C5 cervical spinal cord injury, diagnosed per 2019 revised ISNCSCI of ASIA, injury grade A to B; Intact cognitive function, MoCA-BLIND score ≥19; Elbow flexor muscle strength ≤ Grade 3 by ISNCSCI; Neurological assessment confirms normal motor cortex function without significant organic or functional brain lesions; Tetraplegia diagnosed for ≥12 months, stable clinical status ≥6 months after standard treatment; Good compliance, voluntary participation; informed consent signed by subject or legal representative.
Exclusion: Participated in other clinical trials within 1 month prior to enrollment; High surgical risk: active systemic infection, coagulation disorders, antithrombotic therapy users; Unstable medical conditions, severe mental/cognitive disorders confounding endpoint assessment; Severe, unstable, uncontrolled complex regional pain syndrome; Autoimmune-induced spinal cord dysfunction/injury; History of stroke, multiple sclerosis, drug-resistant epilepsy, Alzheimer's Disease; Syringomyelia, severe neuralgia or spasticity limiting training participation; Require tracheotomy, mechanical ventilation, nasogastric feeding to sustain vital functions; Subjects implanted with CNS electrical stimulation medical devices; Peripheral neuropathy; Pregnant/breastfeeding females, females planning pregnancy during trial; Require MRI examinations during device implantation period; Investigator judges participation unsafe, or subject unlikely to complete protocol follow-up.