NeuroSuitUp: Neurorehabilitation Through Synergistic Man-machine Intrefaces Promoting Dormant Neuroplasticity in Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- BCI control (yes/no)
研究概览
简要总结
NeuroSuitUp is a multidisciplinary neurophysiological & neural rehabilitation engineering project, developed by the Lab of Medical Physics & Digital Innovation, School of Medicine, Faculty of Health Science Aristotle University of Thessaloniki and supported by a Neurosurgical Department. This research is co-financed by Greece and the European Union (European Social Fund- ESF) through the Operational Programme "Human Resources Development, Education and Lifelong Learning 2014- 2020" in the context of the project ""NeuroSuitUp"" (MIS 5047840). The website for the project can be accessed at https://imedphys.med.auth.gr/project/neurosuitup .
The investigation's primary objectives include the development, testing and optimization of an intervention based on multiple immersive man-machine interfaces offering rich feedback, that include a) mountable robotic arm controlled with wireless Brain-Computer Interface and b) wearable robotics jacket & gloves in combination with a serious game application and c) augmented reality module for the presentation of the previous two, as well as the development and validation of a self-paced neuro-rehabilitation protocol for patients with Cervical Spinal Cord Injury and the study of cortical activity in chronic spinal cord injury.
详细描述
NeuroSuitUp project's full title is <Neurorehabilitation through synergistic man-machine intrefaces promoting dormant neuroplasticity in spinal cord injury> . It is a multidisciplinary neurophysiological & neural rehabilitation engineering project project, developed by the Lab of Medical Physics & Digital Innovation, School of Medicine, Faculty of Health Science Aristotle University of Thessaloniki and supported by a Neurosurgical Department. This research is co-financed by Greece and the European Union (European Social Fund- ESF) through the Operational Programme "Human Resources Development, Education and Lifelong Learning 2014- 2020" in the context of the project ""NeuroSuitUp"" (MIS 5047840). The website for the project can be accessed at https://imedphys.med.auth.gr/project/neurosuitup .
The NeuroSuitUp project involves:
- A clinical study for rehabilitation of patients with Cervical Spinal Cord Injury (CSCI), using multiple immersive man-machine interfaces (Brain-Computer Interface (BCI) controlled robotic arms device, Wearable Robotics Jacket & Gloves, Serious Gaming Application, Augmented Reality presentation)
- A secondary off-line neurophysiological analysis of brin cortical activation, connectivity and plasticity as well as muscle electrophysiology in patients with CSCI undergoing motor imagery (MI) and BCI training and assistance through electrical muscle stimulation
Milestones of the study:
- The investigators aim to develop, test and optimize an intervention based on multiple immersive man-machine interfaces
- The investigators aim to develop and validate self-paced neuro-rehabilitation protocols for patients with CSCI.
- The investigators aim to identify and study the neurophysiological functionality and alteration of cortical activity in chronic CSCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 14 yearss of age
- •clinical diagnosis of Spinal Cord Injury (SCI evaluated by ASIA Impairment Scale) OR Healthy participants (age and gender matched to SCI patients)
- •Sufficient documentation of the injury in case of patients (neurological examination, MRI scan of the injury level, optional additional CT or x-rays).
- •Signed informed consent (patients and healthy individuals).
排除标准
- •Other neurological condition that has a possibility to significantly affect the neurological status of the participants (or) the ability to control a BCI (or) the neurophysiological recordings:
- •Traumatic brain injury
- •Central Nervous System tumors
- •Multiple Sclerosis
- •Amyotrophic Lateral Sclerosis
- •Parkinson's disease
- •Refractory Epilepsy
- •Participation during the last 3months in an another interventional study, the effects of which could affect this study's observations.
- •Other grave medical condition that could affect the participation (or) the safety of the participants:
- •Cardiac deficiency
- •Pulmonary deficiency
- •Hearing and visual impairments that can affect the participant's understanding of the intervention and performance.
- •Illegal drug use
- •Chronic alcoholism
结局指标
主要结局
BCI control (yes/no)
时间窗: Immediately after the intervention
Ability of participants to modulate brainwave activity in order to achieve control of the BCI. BCI control is evaluated as achieved or not (there are cases of BCI-illiteracy when the participants cannot modulate their brainwaves in order to control the BCI).
Serious game performance (in-game scoring system)
时间窗: Immediately after the intervention
The ability of participants to control the wearables robotic jacket in order to complete in-game tasks and collect more points. The points will be gather be matching the speed and position of the in-game task instructions while receiving assistance from electrical muscle stimulation. The in-game scoring system uses an accumulative scoring regime according to the correct execution of tasks. There is no upper limit to the score and a higher score means better task execution. Counting starts at 0.
次要结局
- Initial Functional Improvement (Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III)(3 months after first participant in first session)
- BCI performance classification accuracy(6 months after first participation in first session)
- Long-term Functional Improvement (Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III)(One year after first participant in first session)
- Intermediate Functional Improvement (Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III)(6 months after first participant in first session)
- BCI performance by bit rate(6 months after first participation in first session)
研究者
Alkinoos Athanasiou
Dr. PhD
Aristotle University Of Thessaloniki