NCT05465486

NeuroSuitUp: Neurorehabilitation Through Synergistic Man-machine Interfaces

NeuroSuitUp: Neurorehabilitation Through Synergistic Man-machine Intrefaces Promoting Dormant Neuroplasticity in Spinal Cord Injury

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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. The sensorimotor networks of Spinal Cord Injury (SCI) patients and healthy individuals share similar connectivity patterns of but new functional interactions have been identified as unique to SCI patient networks and can be attributed to both adaptive and maladaptive organization effects after the injury . The importance of such phenomena both as possible prognostic factors and as contributors to patient rehabilitation remains unspecified as of yet. The exact underlying neurophysiological process and the extent that this is modulated by higher-order interactions is also not fully understood. Far more importantly, it has recently demonstrated for the first time partial neurological recovery in complete SCI patients after 5-10 years from the injury through ground-breaking neuro-rehabilitation protocols, integrated into traditional medical and physiotherapy practice. The investigators used rich visual and tactile feedback, virtual reality environments (VRE), BCI controlled exoskeleton and robotic actuators and furthermore documented plasticity effects at the cortical level. Residual communication between brain and spinal cord plays an important role in possible neurorehabilitation, as even in complete injuries one fourth of nerve fibers crossing the injury level are functionally intact. As such, retraining CNS circuits and promoting plasticity to restore body functions have been recognized among key principles of spinal cord repair by the US National Institute of Neurological Disorders and Stroke (US NIH/NINDS). Nonetheless, existing literature does not yet portray with precision the pathophysiological process and effect of SCI on CNS and the sensorimotor networks. Studies needed to address this issue (such as our study) should be considered, identifing specific questions to be answered through further investigation: a) how and why reorganization of CNS networks is established, b) how this reorganization evolves in time with respect to the severity and chronicity of the injury, c) when can it be considered an adaptive or maladaptive evolution, and d) how can it be promoted or prevented respectively. The gained insight is expected to hold clinical relevance in preventing maladaptive plasticity after SCI through individualized neuro-rehabilitation, as well as in the design of assistive technologies for SCI patients. This NeuroSuitUp study is a both a pre-clinical neurophysiological investigation on human SCI patients that aims to advance basic knowledge on SCI sequelae to CNS and also a translational implementation in clinical (rehabilitation) practice.. Our analysis aims to eventually help produce a model of CNS function along different stages of SCI (Acute, Sub-acute, Chronic), during different activity (resting state, simple motor tasks, complex sensorimotor activity), differentiate between Complete and Incomplete Injury and ideally being able to predict Negative outcome versus possible Recovery. The NeuroSuitUp project aims to investigate and promote dormant neuroplasticity after chronic SCI at the cervical spine, a type of injury that causes tetraparesis and tetraplegia. Our protocol will deploy training in brain computer interfaces and robotic arms, virtual environments (brain-controlled virtual arms, avatars and augmented reality wearable robotics with sensors and actuators (gloves \& jacket) and rich audio/visual/tactile stimuli along with serious gaming applications to enhance motivation. Visual and kinesthetic sensorimotor brain networks will be also studied using high density electroencephalography in order to demonstrate and monitor CNS plasticity.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	Brain-Computer Interface control of robotic arms with augmented reality	The participants will be trained to modulate self-paced Visual Motor Imagery (VMI) and Kinesthetic Motor Imagery (KMI) under EEG recording in order to achieve BCI-control of a custom-built bimanual arms robot (MERCURY v2.0). In KMI they will be asked to modulate brain waves in order to learn to control the BCI and in VMI they will additionally be projected a visual cue (representation of the intended movement). BCI will be used to control the arms in physical space as well as in an Augmented Reality Environment. Each participant will take part in 3 sessions Device: robotic arms MERCURY v2.0 robotic arms is a non-commercial 6-degree-of-freedom anthropomorphic bimanual robotic arms device that was built and developed by the research team of the Medical Physics \& Digital Innovation Lab.
DEVICE	Serious game with augmented reality	The participants will don wearable robotics and use them as input to play a dojo-themed immersive serious game intended at tracking participants movement and presenting them with motor tasks to perform. The game wiil be played in a computer screen, as well as in an Augmented Reality Environment. Each participant will take part in 10 sessions Device: Wearable robotics The NeuroSuitUp wearable robotics jacket \& gloves are non-commercial wearable devices, equiped with inertial motion units, electromyography and electrical muscle stimulation, built and developed by the Medical Physics \& Digital Innovation Lab

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-07-19
• Last updated: 2024-07-31

Locations

1 site across 1 country: Greece