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

Sponsor
Shanghai StairMed Technology Co., Ltd.
Study ID
NCT06829212
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • WRS — DEVICE
    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).

Study Details

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.

Key Dates

First listed
Feb 17, 2025
Start date
Mar 31, 2025
Status verified
Mar 2025
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
4 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Implantation
    Implantation of the WRS64

Primary Outcome Measure

Device-Related Adverse Events (AE) [ Time Frame: Through study completion, an average of 7 months ]

Central Contacts

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