💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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