Actively Recruiting
Research on Wireless Brain Implant System for General Control of External Devices
Led by Shanghai StairMed Technology Co., Ltd. · Updated on 2025-03-13
4
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
Sponsors
S
Shanghai StairMed Technology Co., Ltd.
Lead Sponsor
H
Huashan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Research on Wireless Brain Implant System for General Control of External Devices
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
S
Stairmed Clinical team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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