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
Shanghai StairMed Technology Co., Ltd.
4 participants
Mar 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria12
- 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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Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06829212