Brainwave Control of a Wearable Robotic Arm for Rehabilitation and Neurophysiological Study in Cervical Spine Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- BCI control (yes/no). (ability of participants to modulate brainwave activity in order to achieve control of the BCI)
研究概览
简要总结
CSI:Brainwave is a multidisciplinary neurophysiological project, developed by the Lab of Medical Physics, School of Medicine, Aristotle University of Thessaloniki and supported by two Neurosurgical Departments. The project officially commenced on April 2014 and the first year was awarded the 2013 Mario Boni Research Grant by the Cervical Spine Research Society-European Section (CSRS-ES). The website for the project can be accessed at http://medphys.med.auth.gr/content/csi-brainwave.
The investigation's primary objectives include the development, testing and optimization of a mountable robotic arm controlled with wireless Brain-Computer Interface, 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 acute and chronic spinal cord injury.
详细描述
CSI:Brainwave project's full title is <Brainwave control of a wearable robotic arm for rehabilitation and neurophysiological study in Cervical Spine Injury> . It is a multidisciplinary neurophysiological project, developed by the Lab of Medical Physics and supported by two Neurosurgical Departments.
The CSI:Brainwave project involves:
- A clinical study for rehabilitation of patients with Cervical Spinal Cord Injury (CSCI), using a Brain-Computer Interface (BCI) controlled robotic arms device.
- A secondary off-line neurophysiological analysis of cortical activation, connectivity and plasticity in patients with CSCI undergoing motor imagery (MI) practice.
Milestones of the study:
- The investigators aim to develop, test and optimize a mountable robotic arm controlled with wireless BCI.
- 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 acute and 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
- •Clinical diagnosis of Spinal Cord Injury (SCI evaluated by ASIA Impairment Scale).
- •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). (ability of participants to modulate brainwave activity in order to achieve control of the BCI)
时间窗: 1 month after first participation in a BCI session.
The 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).
次要结局
- Initial Functional Improvement (Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III)(6 months after first participation in a BCI session.)
- BCI performance (classification accuracy (percentage of voluntary non-erroneous commands to overall number of detected commands) and by bit rate (number of commands per minute)(6 months after first participation in a BCI session.)
- Long-term Functional Improvement (Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III)(1 year after first participation in a BCI session.)
研究者
Panos Bamidis
Assistant Professor
Aristotle University Of Thessaloniki