NCT07647315招募中不适用
Wireless Implantable Mandarin Chinese Speech Neuroprosthesis Evaluation
Shanghai StairMed Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Incidence of Device-Related Adverse Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Implantation of the WRS
Experimental
干预措施: WRS (Device)
结局指标
主要结局
Incidence of Device-Related Adverse Events
时间窗: From implantation to Month 12
Adverse events determined by the investigator to be related to the investigational device, recorded throughout the study period.
次要结局
- Incidence of All Adverse Events(From implantation to Month 12)
- Incidence of Device Deficiencies(From implantation to Month 12)
- Number of Reliable Recording Channels at Each Evaluation Time Point(At 3, 6, 9, and 12 months post-implantation)
- Speech Output Rate in Characters Per Minute (CPM)(At 3, 6, 9, and 12 months post-implantation)
- Speech Output Character Error Rate (CER)(At 3, 6, 9, and 12 months post-implantation)
研究者
研究点 (1)
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