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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. - willing to sign a consent form signed by participant and/or caregiver, with full understanding of the trial's purpose. Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body)s. - Life expectancy under 1 year. - Drug or alcohol abuse. - Pregnant, breastfeeding, or planning pregnancy during the study. - Other conditions deemed unsuitable by the investigator. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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).

Locations (1)

Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China