Research on Wireless Brain Implant System for General Control of External Devices
NCT06829212 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2025-03-13
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.
Conditions
- Complete or Incomplete Paraplegia/quadriplegia
- Spinal Cord Injury
- Brainstem Stroke
- Amyotrophic Lateral Sclerosis
- Bilateral Upper Limb Amputation
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).
Sponsors & Collaborators
-
Huashan Hospital
collaborator OTHER -
Shanghai StairMed Technology Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-31
- Primary Completion
- 2027-02-28
- Completion
- 2027-02-28
Countries
- China
Study Locations
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