NCT07784088招募中不适用
A Prospective, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of Implantable Wireless Brain-Computer Interface Systems in Patients With Tetraplegia
BCIFlex Medical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2026年7月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Success rate of brain-controlled tasks
研究概览
简要总结
Objectives of Study: This trial aims to evaluate the safety and efficacy of an implantable wireless brain-computer interface system in patients with tetraplegia resulting from spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and ≤65 years, male or female;
- •Tetraplegia due to C2-C5 cervical spinal cord injury, diagnosed per 2019 revised ISNCSCI of ASIA, injury grade A to B;
- •Intact cognitive function, MoCA-BLIND score ≥19;
- •Elbow flexor muscle strength ≤ Grade 3 by ISNCSCI;
- •Neurological assessment confirms normal motor cortex function without significant organic or functional brain lesions;
- •Tetraplegia diagnosed for ≥12 months, stable clinical status ≥6 months after standard treatment;
- •Good compliance, voluntary participation; informed consent signed by subject or legal representative.
排除标准
- •Syringomyelia, severe neuralgia or spasticity limiting training participation;
- •Require tracheotomy, mechanical ventilation, nasogastric feeding to sustain vital functions;
- •High surgical risk: active systemic infection, coagulation disorders, antithrombotic therapy users;
- •Subjects implanted with CNS electrical stimulation medical devices;
- •Unstable medical conditions, severe mental/cognitive disorders confounding endpoint assessment;
- •Severe, unstable, uncontrolled complex regional pain syndrome;
- •Autoimmune-induced spinal cord dysfunction/injury;
- •History of stroke, multiple sclerosis, drug-resistant epilepsy, Alzheimer's Disease;
- •Peripheral neuropathy;
- •Pregnant/breastfeeding females, females planning pregnancy during trial;
- •Require MRI examinations during device implantation period;
- •Participated in other clinical trials within 1 month prior to enrollment;
- •Investigator judges participation unsafe, or subject unlikely to complete protocol follow-up.
结局指标
主要结局
Success rate of brain-controlled tasks
时间窗: 2, 3, 6 months post-implant
次要结局
- Digital Instrumental Activities of Daily Living (dIADL)(2, 3, 6 months post-implant)
- Device Reliability(up to 6 months post-implant)
- Investigator Satisfaction with Device Operation(2, 3, 6 months post-implant)
- Brain Control Fluency Index(2, 3, 6 months post-implant)
- Patient Health Questionnaire-9 (PHQ-9)(Baseline, 2, 3, 6 months post-implant)
- Average Monthly Device Usage Duration(6 months post-implant)
- WHO Quality of Life BREF(Baseline, 2, 3, 6 months post-implant)
- Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)(Baseline, 2, 3, 6 months post-implant)
- Psychosocial Impact of Assistive Devices Scale (PIADS)(2, 3, 6 months post-implant)
- Subject Satisfaction with the Device(2, 3, 6 months post-implant)
研究者
研究点 (1)
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