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Wireless Implantable Mandarin Chinese Speech Neuroprosthesis Evaluation
Sponsor: Shanghai StairMed Technology Co., Ltd.
Summary
This prospective, single-arm clinical trial is designed to preliminarily evaluate the safety and efficacy of an implantable wireless brain-computer interface (BCI) system (manufactured by Shanghai StairMed Technology Co., Ltd.) in enabling subjects with speech disorders to achieve brain-controlled interaction and communication. Eligible subjects will undergo surgical implantation of the device and receive brain-control training. All participants will be followed for an expected period of 12 months. During the follow-up, adverse events, serious adverse events, and device deficiencies will be recorded, and efficacy data on brain-controlled interaction and communication will be collected. The goal is to conduct an initial assessment of the safety and effectiveness of the investigational device in achieving brain-controlled effects in the target population.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
4
Start Date
2026-06-30
Completion Date
2028-12-30
Last Updated
2026-06-15
Healthy Volunteers
No
Conditions
Interventions
WRS
WRS is a minimally invasive, wireless brain-machine interface system. Subjects with speech disorders undergo implantation of WRS, receive brain-control training, and are followed up.
Locations (1)
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China