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โ† Trials
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Research on Wireless Brain Implant System for General Control of External Devices

RecruitingNAAges 18 Years - 80 YearsAllShanghai StairMed Technology Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • WRS
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Where

1 site
Huashan Hospital Affiliated to Fudan University
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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