Safety and Efficacy of High-Channel Implanted Brain-Computer Interface in Promoting Motor Function Improvement in Patients With Tetraplegia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Grasping Success Rate
研究概览
简要总结
This is an open-label single-arm clinical study conducted at designated clinical trial institutions, with three overall phases: a 3-month main study, a 3-month extension, and a 3-month follow-up. The main study includes screening/baseline, preoperative preparation, surgery, upper limb rehabilitation adjustment, and pneumatic hand function training-specifically, preoperative brain and spinal cord imaging for electrode placement in eligible subjects, implantation of high-channel electrodes, and postoperative combined rehabilitation to build a motor intention decoding model that drives the pneumatic hand to grasp. The extension phase focuses on precise assessment of upper limb grasping function, signal stability monitoring, implantation of epidural spinal cord test electrodes, and closed-loop regulated epidural electrical stimulation for limb rehabilitation using implanted intracranial electrode signals. The follow-up phase involves intracranial electrode removal, implantation of long-term epidural spinal cord electrodes, and limb rehabilitation training and observation based on scalp EEG signals.
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
- •18-65 years old (no gender restriction)
- •Clinically diagnosed with tetraplegic motor dysfunction following brainstem or spinal cord injury
- •≥ 6 months after brainstem or spinal cord injury, with stable condition (spinal shock phase has passed, and no significant improvement or deterioration in sensory and motor function)
- •Bilateral upper limb muscle strength ≤ Grade 2 and bilateral lower limb muscle strength ≤ Grade 3 by Manual Muscle Testing (MMT)
- •Cognitive function: Mini-Mental State Examination (MMSE) score ≥ 20
排除标准
- •Females who are pregnant
- •History of drug abuse or alcoholism
- •Diseases that limit limb mobility: fractures (progressive/deformity-causing fractures), hip dysplasia and other diseases causing limited hip mobility, diabetic foot, severe osteoporosis, limb joint contracture deformity, spasticity, and hospitalization due to autonomic dysreflexia in the past 3 months
- •Neurological diseases/injuries: traumatic brain injury, epilepsy, neurodegenerative diseases or neuropathies, severe anxiety or depression, and suicidal ideation
- •Surgical contraindications: infectious diseases; unstable angina pectoris, severe arrhythmia, and other heart diseases; immune system diseases and major organ diseases; coagulation disorders and bleeding tendencies; ankylosing spondylitis; malignant tumors; spinal instability and spinal stenosis
- •BMI ≥ 30.0 kg/m²
- •Patients with depressive disorder (17-item Hamilton Depression Rating Scale [HAMD] score > 17)
- •Patients unable to comply with the study protocol
研究组 & 干预措施
IBCI
Receive invasive BCI intervention
干预措施: Invasive BCI (Other)
结局指标
主要结局
Grasping Success Rate
时间窗: Before surgery and 1 week, 1 month, and 3 months after surgery
The proportion of successful attempts in completing designated grasping movements, including basic grasping and functional grasping
次要结局
- Grasping Object Type Coverage(Before surgery and 1 week, 1 month, and 3 months after surgery)
- Brain-Controlled Command Recognition Accuracy(Before surgery and 1 week, 1 month, and 3 months after surgery)
- Grasping Latency(Before surgery and 1 week, 1 month, and 3 months after surgery)
- Manual Muscle Testing (MMT)(Before surgery and 1 week, 1 month, and 3 months after surgery)
- Modified Ashworth Scale (MAS) for Spasticity(Before surgery and 1 week, 1 month, and 3 months after surgery)
- 3-Meter Walking Time(Before surgery and 1 week, 1 month, and 3 months after surgery)
- Step Width (Motion Capture)(Before surgery and 1 week, 1 month, and 3 months after surgery)
- Step Length (Motion Capture)(Before surgery and 1 week, 1 month, and 3 months after surgery)
- Step Height (Motion Capture)(Before surgery and 1 week, 1 month, and 3 months after surgery)
- Step Frequency (Motion Capture)(Before surgery and 1 week, 1 month, and 3 months after surgery)
- Walking Speed (Motion Capture)(Before surgery and 1 week, 1 month, and 3 months after surgery)
- Plantar Pressure Value(Before surgery and 1 week, 1 month, and 3 months after surgery)
- Limb Muscle Volume(Before surgery and 1 week, 1 month, and 3 months after surgery)
- Visual Analog Scale (VAS)(Before surgery and 1 week, 1 month, and 3 months after surgery)
- Sexual Health Inventory for Men (SHIM) / Sexual Complaints Screener for Women (SCS-W)(Before surgery and 1 week, 1 month, and 3 months after surgery)
- International Consultation on Incontinence Questionnaire-Short Form (ICI-Q-SF) Score for Urinary Retention(Before surgery and 1 week, 1 month, and 3 months after surgery)
- Neurogenic Bowel Dysfunction (NBD)(Before surgery and 1 week, 1 month, and 3 months after surgery)