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Clinical Trials in China / NCT07784088
Recruiting Not applicable

Implantable Wireless Brain-Computer Interface Systems in Patients With Tetraplegia

NCT07784088 · tracked via the Priya Life Science China tracker
Sponsor
BCIFlex Medical Technology Co., Ltd.
Phase
Not applicable
Started
2026-07-15
Last updated
2026-08-25

Condition(s) studied

Spinal Cord Injury CervicalTetraplegia/TetraparesisSpinal Cord Injuries (SCI)

Investigational drug(s) / intervention(s)

IWBCIS

IWBCIS: Implantable wireless brain-computer interface systems

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beijing Tiantan Hospital, Capital Medical University Beijing China Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07784088 on ClinicalTrials.gov ↗ ← All trials in China