Clinical Trial

Wireless Implantable Mandarin Chinese Speech Neuroprosthesis Evaluation

Study acronym: WISE
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07647315
Lead Sponsor Shanghai StairMed Technology Co., Ltd.
Conditions Speech Disorder
Enrollment 4 participants
Start Date 2026-06-30
Primary Completion 2028-06-30 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-15