Wireless Implantable Mandarin Chinese Speech Neuroprosthesis Evaluation

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Incidence of Device-Related Adverse Events [Срок оценки: From implantation to Month 12]

Вторичные конечные точки (3)

• Incidence of All Adverse Events [Срок оценки: From implantation to Month 12]
• Incidence of Device Deficiencies [Срок оценки: From implantation to Month 12]
• Number of Reliable Recording Channels at Each Evaluation Time Point [Срок оценки: At 3, 6, 9, and 12 months post-implantation]

Критерии участия

Критерии включения

• Age 18 to 80 years (inclusive), any gender.
• Clinically diagnosed with speech disorders, including locked-in syndrome, severe dysarthria, aphasia with preserved auditory comprehension, or late-stage ALS-related language dysfunction, secondary to stroke, traumatic brain injury, amyotrophic lateral sclerosis (ALS), or other motor neuron diseases.
• The subject, or the subject with the assistance of their legal representative, is willing to follow the investigator's instructions, adhere to all protocol-specified procedures, and complete all required follow-up.
• The subject and their legal representative fully understand the purpose and significance of the trial; the subject voluntarily agrees to participate and signs the informed consent form

Критерии исключения

• Subjects with any previously implanted metallic objects or devices (e.g., pacemakers, defibrillators, neurostimulators, cochlear implants), except for dental metal implants or implants assessed to have no impact on the trial.
• Subjects who have been on long-term anticoagulant or antiplatelet therapy prior to screening, with antiplatelet drugs discontinued for less than 2 weeks before surgery; or subjects with hematological or autoimmune disorders (e.g., aplastic anemia, systemic lupus erythematosus); or subjects with clinically significant coagulation test abnormalities during the screening period.
• Subjects assessed by an anesthesiologist to be unable to tolerate anesthesia and surgery.
• Subjects assessed by the investigator to have nervous system diseases (e.g., cerebrovascular lesions, intracranial infections, neurodegenerative diseases, epilepsy) or a history of craniocerebral trauma, resulting in severe brain function impairment or marked EEG abnormalities.
• Subjects with physiological or pathological conditions that may lead to poor healing of scalp wounds.
• Subjects in the acute infection phase or suffering from other severe infections.
• Subjects with cognitive impairment or psychotic symptoms.
• Subjects with severe dysfunction of vital organs (heart, lung, liver, kidney, etc.), malignant tumors or autoimmune diseases, who are deemed ineligible for this clinical trial by investigators.
• Subjects judged by investigators to have an expected survival time of less than 1 year.
• Subjects with drug abuse or alcohol dependence.
• Pregnant or breastfeeding women, or subjects planning to become pregnant during the trial period.
• Subjects currently participating in clinical trials of drugs or other medical devices.
• Subjects unable to understand or read Chinese.
• Other circumstances under which investigators consider the subject unsuitable to participate in this clinical trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

Китай · 1 центр

• Huashan Hospital, Fudan University — Шанхай

Идентификаторы

NCT: NCT07647315 · STAIRSUP-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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