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RECRUITING
NCT06829212
NA

Research on Wireless Brain Implant System for General Control of External Devices

Sponsor: Shanghai StairMed Technology Co., Ltd.

View on ClinicalTrials.gov

Summary

The clinical trial aims to evaluate the safety and efficacy of the minimally invasive, wireless brain-machine interface system (WRS) in enabling general brain control of external devices, such as a cursor and other assistive technologies, for paralyzed and amputee patients. WRS integrates a high-throughput, ultra-flexible neural electrode with an extremely small cross-sectional size-approximately one-hundredth the diameter of a human hair. Moreover, the implantable component is fully embedded within the body, leaving no visible external traces.

Official title: A Prospective Clinical Trial to Evaluate the Safety and Efficacy of Implantable Wireless Recording System (WRS) for General Control of External Devices in Paralyzed/Amputee Patients

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

4

Start Date

2025-03

Completion Date

2027-02

Last Updated

2025-03-13

Healthy Volunteers

No

Interventions

DEVICE

WRS

WRS is a minimally invasive, wireless brain-machine interface system, consisting of a wireless implanted neural signal collector(Model: WRS64), data energy transmitter(Model: DTC01/02), and a brain function information management platform software(Model: SW01).

Locations (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China