Wireless Implantable Mandarin Chinese Speech Neuroprosthesis Evaluation
Sponsor: Shanghai StairMed Technology Co., Ltd. • ClinicalTrials.gov ID: NCT07647315
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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.
Interventions
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WRS
(Device)
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.
Eligibility criteria
Conditions
Locations
- Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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