Wireless implant for brain-computer interface in people with tetraplegia from spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates an implantable wireless brain-computer interface system in adults aged 18 to 65 with cervical spinal cord injury causing tetraplegia. Participants must have stable neurological condition, intact cognitive function, and limited elbow flexor strength, and must meet specific ASIA impairment criteria. The study will monitor safety and potential efficacy signals of the implanted device, with follow-up designed to assess device performance and any functional changes. No comparator is specified in the available details, and the trial is led by BCIFlex Medical Technology with collaboration from Beijing Tiantan Hospital in China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* Syringomyelia, severe neuralgia or spasticity limiting training participation;
* Require tracheotomy, mechanical ventilation, nasogastric feeding to sustain vital functions;
* High surgical risk: active systemic infection, coagulation disorders, antithrombotic therapy users;
* Subjects implanted with CNS electrical stimulation medical devices;
* 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;
* Peripheral neuropathy;
* Pregnant/breastfeeding females, females planning pregnancy during trial;
* Require MRI examinations during device implantation period;
* Participated in other clinical trials within 1 month prior to enrollment;
* Investigator judges participation unsafe, or subject unlikely to complete protocol follow-up.

Where it's running

• Beijing Tiantan Hospital, Capital Medical University
  Beijing, China Recruiting

Study contacts

• Study coordinator: BCIFlex
• Email: wangxp@bciflex.com
• Phone: +86 10 5365 7080

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.