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).
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Aged 18-80 years (inclusive), any gender.
* Diagnosed with spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis, or other motor neuron diseases causing partial or complete paralysis, or bilateral upper limb amputation.
* Diagnosis stable for at least 6 months before screening, with the condition present for at least 1 year.
* Willing to follow the study protocol and attend all visits, with or without caregiver assistance.
* Informed consent signed by participant and/or caregiver, with full understanding of the trial's purpose.
Exclusion Criteria:
* Previous implantation of metal objects or devices (except dental implants or non-impacting implants).
* Long-term use of anticoagulants/antiplatelets with insufficient cessation, or abnormal coagulation test results.
* Unable to tolerate anesthesia or surgery.
* Severe neurological disorders or brain injury leading to significant dysfunction.
* Scalp conditions that may impair wound healing.
* Acute or severe infections.
* Cognitive impairment or psychiatric disorders.
* Severe dysfunction of vital organs, malignancies, or autoimmune diseases.
* Life expectancy under 1 year.
* Drug or alcohol abuse.
* Pregnant, breastfeeding, or planning pregnancy during the study.
* Other conditions deemed unsuitable by the investigator.
Primary outcome measure(s)
Device-Related Adverse Events (AE) — Through study completion, an average of 7 months
Trial sites (1)
Facility
City
Region
Status
Huashan Hospital Affiliated to Fudan University
Shanghai
Shanghai Municipality
Recruiting
More Shanghai StairMed Technology Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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