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

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

DEVICE

NEO

a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO

Sponsors & Collaborators

• Huashan Hospital

  collaborator OTHER

• Xuanwu Hospital, Beijing

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• First Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• Beijing Tiantan Hospital

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Affiliated Hospital of Nantong University

  collaborator OTHER

• The General Hospital of Eastern Theater Command

  collaborator OTHER

• Peking University Third Hospital

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Neuracle Medical Technology(Shanghai) Co.,Ltd.

  lead INDUSTRY

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-20

Primary Completion

2025-12-31

Completion

2026-05-20

Countries

• China

Study Locations