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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
4
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).
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGDevice-Related Adverse Events (AE)
Time frame: Through study completion, an average of 7 months
Adverse Events
Time frame: Through study completion, an average of 7 months
Serious Adverse Event
Time frame: Through study completion, an average of 7 months
BPS
Bits per second, determined by the net number of correct targets selected per minute (NTPM) during task participation by the subject, and the grid size.
Time frame: At an average of 4 to 7 months after implantation, both before and during the follow-up phases.
Usage Time (hours/month)
The amount of time the subject uses the experimental device each month.
Time frame: At an average of 5 to 7 months after implantation, during the follow-up phases.
Accuracy
The percentage of correctly completed commands from the total commands in the predefined task list, which are independently completed by the subject within a specified time.
Time frame: At an average of 5 to 7 months after implantation, during the follow-up phases.
Psychological State
The subject and/or their caregiver will complete the checklist to assess psychological states and other relevant indicators (each question is graded from 1 to 5, with lower values being better).
Time frame: At an average of 4 to 7 months after implantation, both before and during the follow-up phases.
Caregiver Burden
The subject's caregiver will complete the checklist to assess caregiver burden and other related indicators (each question is scored from 0 to 4, with lower scores being better).
Time frame: At an average of 4 to 7 months after implantation, both before and during the follow-up phases.
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