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Wireless Implantable Mandarin Chinese Speech Neuroprosthesis Evaluation

Study acronym: WISE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Jun 30, 2028 → Aug 30, 2028
See other at-risk trials from Shanghai StairMed Technology Co., Ltd.

Record History

See every version on ClinicalTrials.gov ↗

  1. Recruitment openedv2 Show 4 more changesShow less
    • Primary completion pushed from Jun 30, 2028 to Aug 30, 2028
    • Start date changed from estimate of Jun 30, 2026 to Sep 1, 2026
    • Secondary endpoints: 3 to 5
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
(from sponsor)		 Speech Disorder
Related terms Speech Disorders
Enrollment 4 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov