Recruiting
Not applicable
Wireless Implantable Mandarin Chinese Speech Neuroprosthesis Evaluation
Condition(s) studied
Speech Disorder
Investigational drug(s) / intervention(s)
WRS
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.
Study 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.
Eligibility
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
Primary outcome measure(s)
- Incidence of Device-Related Adverse Events — From implantation to Month 12
Adverse events determined by the investigator to be related to the investigational device, recorded throughout the study period.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Huashan Hospital, Fudan University |
Shanghai |
Shanghai Municipality |
Recruiting |
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