NeuroSuitUp: Neurorehabilitation Through Synergistic Man-machine Interfaces

Spinal Cord Injuries Clinical Trial

— NeuroSuitUp  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05465486
• Other study ID #: 249473/2019
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Aristotle University Of Thessaloniki
• Contact: Alkinoos Athanasiou, PhD
• Phone: +302310999237
• Email: athalkinoos[@]auth.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

NeuroSuitUp project's full title is . 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

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.
• 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

Locations

Country	Name	City	State
Greece	Laboratory of Medical Physics and Digital Innovation, AUTH	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCI control (yes/no)	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).	Immediately after the intervention
Primary	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. 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.	Immediately after the intervention
Secondary	Initial Functional Improvement (Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III)	Daily functionality as measured by the Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III).; Score ranges from 0 (min, no functional independence) to 100 (max, fully independent).	3 months after first participant in first session
Secondary	Intermediate Functional Improvement (Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III)	Daily functionality as measured by the Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III).; Score ranges from 0 (min, no functional independence) to 100 (max, fully independent).	6 months after first participant in first session
Secondary	Long-term Functional Improvement (Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III)	Daily functionality as measured by the Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III).; Score ranges from 0 (min, no functional independence) to 100 (max, fully independent).	One year after first participant in first session
Secondary	BCI performance classification accuracy	Achieved performance on BCI at conclusion of BCI sessions for each participant. Measured by classification accuracy (percentage of voluntary non-erroneous commands to overall number of detected commands)	6 months after first participation in first session
Secondary	BCI performance by bit rate	Achieved performance on BCI at conclusion of BCI sessions for each participant. Measured by bit rate (number of commands per minute).	6 months after first participation in first session

External Links

•   Study website