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NOT YET RECRUITING
NCT07647315
NA

Wireless Implantable Mandarin Chinese Speech Neuroprosthesis Evaluation

Sponsor: Shanghai StairMed Technology Co., Ltd.

View on ClinicalTrials.gov

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

DEVICE

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