Trials / Recruiting
RecruitingNCT06829212
Research on Wireless Brain Implant System for General Control of External Devices
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 4 (estimated)
- Sponsor
- Shanghai StairMed Technology Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The investigators' technology is designed to assist paralyzed and amputee patients in regaining certain physical functions, thereby improving participants' overall quality of life and daily convenience. The investigators hope to enable participants to achieve general control over external devices through neural signals in this clinical trial. This eliminates the need for manual manipulation to control devices such as a cursor or other assistive technologies, which can be operated solely through thought. Such advancements will facilitate enhanced communication with loved ones, support the acquisition of new skills, and provide more accessible opportunities for entertainment.
Conditions
- Complete or Incomplete Paraplegia/quadriplegia
- Spinal Cord Injury
- Brainstem Stroke
- Amyotrophic Lateral Sclerosis
- Bilateral Upper Limb Amputation
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2025-03-01
- Primary completion
- 2027-02-01
- Completion
- 2027-02-01
- First posted
- 2025-02-17
- Last updated
- 2025-03-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06829212. Inclusion in this directory is not an endorsement.