NeuroCognitive Communicator Exploratory Safety Study of an Assistive Neuroprosthetic Device for Patients With Severe Upper Motor Disability.
试验速览
- 阶段
- 不适用
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in quality of life as assessed by McGill Quality of Life questionnaire.
研究概览
简要总结
Individuals suffering from tetraplegia as a result of cervical spinal cord injury, brainstem stroke, or amyotrophic lateral sclerosis (ALS) cannot independently perform tasks of daily living. In many cases, these conditions do not have effective therapies and the only intervention is the provision of assistive devices to increase independence and quality of life. However, currently available devices suffer from usability issues and are limiting for both the patient and caregiver. One of the most progressive alternative strategies for assistive devices is the use of brain-computer interface (BCI) technology to translate intention signals directly from sensors in the brain into computer or device action. Preclinical primate research and recent human clinical pilot studies have demonstrated success in restoring function to disabled individuals using sensors implanted directly in motor regions of the brain. Other preclinical primate research has demonstrated effective intention translation from sensors implemented in cognitive regions of the brain and that this information complements information from the motor regions. The current proposal seeks to build on these studies and to test the safety aspects related to implanting two sensors, each a microelectrode array, into both the motor and cognitive regions of the brain in motor impaired humans. Secondary objectives include feasibility evaluation of the complementary sensors in their ability to support effective assistive communication.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of a complete or incomplete cervical spinal cord injury, with stable neurological deficits greater than 1 year, or ALS with equivalent degree of deficit.
- •Maintain some level of communication, enough to independently provide informed consent for the study.
- •Deemed healthy for surgery.
- •Good psychological and social stability.
- •Prospective participants with ALS must already have an advanced directive with regard to ventilation.
- •Live within a one-hour travel duration of the site.
排除标准
- •Presence of previous certain implanted devices.
- •In the opinion of the investigator, the presence of other serious disease or disorder that could affect ability to participate in this study.
- •Ongoing participation in another clinical trial.
- •Individuals who are immunosuppressed or who have conditions that typically result in immunocompromise (eg. chronic corticosteroid use, immunomodulators, chemotherapy).
- •Presence of clinical depression that is not medically optimized, as screened by a neuropsychologist on our team.
- •Presence of cognitive deficits, as assessed by a neuropsychologist on our team, that would preclude completion of some cognitively challenging tasks.
- •The participant has plans to move outside the study radius within the study period.
研究组 & 干预措施
NeuroCognitive Communicator
干预措施: NeuroCognitive Communicator (Device)
结局指标
主要结局
Change in quality of life as assessed by McGill Quality of Life questionnaire.
时间窗: 6 months
McGill Quality of Life questionnaire will be administered monthly; shortened version will be administered 3-4 times per week.
Rate of adverse events
时间窗: 6 months
Transcutaneous connector will be assessed by physician 3-4 times per week for skull and scalp health and lack of infection. All adverse events associated with the system will be measured.
次要结局
- Information transfer rate (measured in bits per second) achieved by each participant calculated during closed-loop operation of the neuroprosthetic device, aggregated across trials within a task.(6 months)
- Percentage of allotted time spent with each augmentative and assistive communication technology.(6 months)
- Coefficients of neuronal activity covariance matrix and their dependence on task performance.(6 months)