A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of minimally invasive, wireless brain-machine interface system (WRS) in patients with paralysis (resulting from spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis, or other motor neuron diseases causing complete or incomplete quadriplegia) or bilateral upper limb amputations. By leveraging brain-machine interface alternative technology, participants can use brain signals to control external devices (such as moving cursors, wheelchairs, robotic arms, WeChat Mini Programs, and other physical assistive devices), thereby improving their motor function and quality of life.
详细描述
The objective of this study is to evaluate the safety and efficacy of minimally invasive, wireless brain-machine interface system (WRS) in patients with paralysis (resulting from spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis, or other motor neuron diseases causing complete or incomplete quadriplegia) or bilateral upper limb amputations. By leveraging brain-machine interface alternative technology, participants can use brain signals to control external devices (such as moving cursors, wheelchairs, robotic arms, WeChat Mini Programs, and other physical assistive devices), thereby improving their motor function and quality of life.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years;
- •Patients with complete or incomplete quadriplegia due to spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis (ALS), or other motor neuron diseases, or those with bilateral upper limb amputations;
- •Normal motor cortex function confirmed by neurological assessment;
- •Muscle strength of bilateral or unilateral upper limbs ≤ Grade 3;
- •Patients who have received standardized treatment and met diagnostic criteria for at least 12 months before screening, with stable disease status for ≥6 months;
- •Expected lifespan ≥12 months;
- •Normal cognitive function;
- •Normal hearing and vision, or corrected vision to normal with standard lenses;
- •Patients with stable caregivers;
- •Willing to sign informed consent and able to comply with follow-up requirements.
排除标准
- •Patients with neuropsychiatric disorders or psychological impairments;
- •Patients with brain MRI findings showing hemorrhage, tumors, anatomical abnormalities, or distortions;
- •History of severe systemic diseases (e.g., cardiac, pulmonary, hepatic, renal, thyroid, gastrointestinal, or hematologic disorders), poorly controlled diabetes, or pregnancy in females;
- •History of infectious diseases (e.g., syphilis, HIV), severe traumatic brain injury, or major surgeries;
- •Presence of metal implants or devices (e.g., cochlear implants, pacemakers, neurostimulators, defibrillators), except for dental implants or other implants deemed non-interfering;
- •Surgical or anesthesia contraindications as determined by surgeons or anesthesiologists;
- •Morbid obesity (BMI >40);
- •Hearing impairment or uncorrectable visual deficits that would hinder prolonged computer monitor viewing;
- •Current participation in other clinical trials;
- •Other conditions considered unsuitable by investigators or medical staff.
研究组 & 干预措施
Implantation of the WRS64
Implantation of the device and follow-up
干预措施: Implant (Device)
结局指标
主要结局
Adverse events
时间窗: Within 6 months after implantation
The incidence of adverse events associated with the device or surgical procedure
次要结局
- WRS Efficacy Assessment- Accuracy(6 months after the implantation)
- WRS Efficacy Assessment- Path efficiency(6 months after the implantation)
- WRS Efficacy Assessment- Time consumption(6 months after the implantation)
- Neurological Recovery Assessment(3, 15, 30, 90, 180 days after implantation)
- Changes in Quality of Life(3, 15, 30, 90, 180 days after implantation)
- Changes in Cognitive Performance(3, 15, 30, 90, 180 days after implantation)
- Changes in Psychological Status(3, 15, 30, 90, 180 days after implantation)
- Changes in Anxiety Status(3, 15, 30, 90, 180 days after implantation)
- Changes in Depression Status(3, 15, 30, 90, 180 days after implantation)