Wireless Implantable Mandarin Chinese Speech Neuroprosthesis Evaluation

Wireless Implantable Mandarin Chinese Speech Neuroprosthesis Evaluation

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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