An interventional study of Brain-Computer Interface control of robotic arms with augmented reality and Serious game with augmented reality in Stroke, sponsored by Aristotle University Of Thessaloniki. Not yet recruiting at 1 site in Greece. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-17.
Sponsored by Aristotle University Of Thessaloniki · Not applicable, Interventional, and Basic science
HEROES 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. The website for the project can be accessed at https://heroes.med.auth.gr.
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 after chronic stroke with severe residual motor disability.
HEROES project's full title is \<Human Extremity Robotic Rehabilitation and Outcome Enhancement for Stroke>. It 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. The website for the project can be accessed at https://heroes.med.auth.gr .
The HEROES project involves:
Milestones of the study:
The brain neuron networks of Chronic Stroke (CS) patients and healthy individuals share similar connectivity patterns of, but new functional interactions have been identified as unique to CS patient networks and can be attributed to both adaptive and maladaptive organization effects after the stroke. The importance of such phenomena both as possible prognostic factors and as contributors to patient rehabilitation remains unspecified yet. The exact underlying neurophysiological process and the extent that this is modulated by higher-order interactions is also not fully understood. 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 brain networks.
Retraining brain 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 CS on Central Nervous System (CNS) and the sensorimotor networks. Studies needed to address this issue (such as our study) should be considered, identifying 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 stroke, 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 CS through individualized neuro-rehabilitation, as well as in the design of assistive technologies for CS patients.
This HEROES study is a both a pre-clinical neurophysiological investigation on human CS patients that aims to advance basic knowledge on CS 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 stroke (Acute, Sub-acute, Chronic), during different activity (resting state, simple motor tasks, complex sensorimotor activity), and ideally being able to predict negative outcome versus possible Recovery. The HEROES project aims to investigate and promote dormant neuroplasticity after chronic stroke, a type of injury that causes hemiparesis, hemiplegia, tetraparesis or 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 also be studied using high density electroencephalography in order to demonstrate and monitor CNS plasticity.
This research project was supported by the Hellenic Foundation for Research and Innovation (H.F.R.I.) https://www.elidek.gr under the "2nd Call for H.F.R.I. Research Projects to support Faculty Members \& Researchers" (Project number: 4391).
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 70 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →Aristotle University Of Thessaloniki is the lead sponsor of 274 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients from Greece, 18 y.o. or older, suffering from chronic stroke and motor disability
Device: Brain-Computer Interface control of robotic arms with augmented reality · Device: Serious game with augmented reality
Patients from Greece, 18 y.o. or older, suffering from chronic stroke and motor disability
Device: Brain-Computer Interface control of robotic arms with augmented reality · Device: Serious game with augmented reality
Healthy participants, age and sex matched to the participants in the other arms
Device: Brain-Computer Interface control of robotic arms with augmented reality · Device: Serious game 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
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 will be played in a computer screen, as well as in an Augmented Reality Environment. Each participant will take part in 10 sessions
BCI control
The ability of participants to modulate brainwave activity in order to achieve control of the BCI will be established. 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).
Time frame: 1 week
Serious game performance (in-game scoring system)
The ability of participants to control the wearables robotic jacket in order to complete in-game tasks and collect more points will be evaluated. The points will be gathered be matching the speed and position of the in-game task instructions while receiving assistance from electrical muscle stimulation.
Time frame: 2 weeks
Initial Functional Improvement (Greek translation of the Modified Rankin Scale (mRS-9Q)
Daily functionality as measured by the Greek translation of the Modified Rankin Scale (mRS-9Q). The scale ranges from 0 to 5, where 0 is the best.
Time frame: 12 months
Plan to share: Yes — Anonymized data will be made available after a Memorandum of Understanding agreement between the Medical Physics and Digital Innovation lab of Aristotle University of Thessaloniki and any interested party.
Supporting information: Study protocol, Icf, Csr
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Aristotle University Of Thessaloniki