The study uses a prospective, single-arm design with a planned enrollment of 4 participants in China, and the intervention is listed under the code WRS. Enrolled subjects undergo surgical implantation of the device followed by brain-control training, with an expected follow-up period of 12 months. During follow-up the investigators record adverse events, serious adverse events and device deficiencies, and collect efficacy data on brain-controlled interaction and communication. Primary completion is estimated for August 30, 2028, with overall completion estimated for December 30, 2028.
The stated goal is an initial assessment of the safety and effectiveness of the investigational device in achieving brain-controlled effects in the target population, which places it at early-feasibility scale. The enrollment of 4 is an estimated figure rather than a completed actual count.
The registry record does not disclose the implant site, the number of recording channels or the decoding approach, and it does not spell out detailed eligibility criteria. No interim results have been posted, so how the system performs at decoding Mandarin remains unknown.