NCT06990412

A Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Wireless Brain-Computer Interface（BCI）System NEO in Patients With Tetraplegia

A Prospective, Multi-Center Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Wireless Brain-Computer Interface（BCI）System NEO in Patients With Tetraplegia

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Neuracle Medical Technology(Shanghai) Co.,Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO in patients with tetraplegia and to provide a basis for product registration. Through brain-computer interface alternative technology, patients can control the external equipment with brain signals to improve the patient's quality of life.

Conditions

• Tetraplegia
• Spinal Cord Injuries (SCI)

Interventions

Type	Name	Description
DEVICE	NEO	a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO

Timeline

• Start date: 2025-05-20
• Primary completion: 2025-12-31
• Completion: 2026-05-20
• First posted: 2025-05-25
• Last updated: 2025-05-25

Locations

2 sites across 1 country: China