NeuroSuitUp: Neurorehabilitation Through Synergistic Man-machine Interfaces

NCT05465486 | Not Yet Recruiting

• 1 other identifier: 249473/2019
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries

Keywords

Complete SCI; Chronic SCI; Incomplete SCI; Cervical Spine Injury; Neuroplasticity; Robotics; Wearables

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Initial Functional Improvement (Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III)

  3 months 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

• 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

• BCI performance classification accuracy

  6 months after first participation in first session

• BCI performance by bit rate

  6 months after first participation in first session

Study Arms (3)

Complete injury at cervical spine

EXPERIMENTAL

Patients from Greece, 14 y.o. or oder, suffering from chronic complete injury at the cervical spinal cord level (ASIA Impairment Scale A)

Device: Brain-Computer Interface control of robotic arms with augmented reality; Device: Serious game with augmented reality

Incomplete Injury at cervical spine

EXPERIMENTAL

Patients from Greece, 14 y.o. or oder, suffering from chronic complete injury at the cervical spinal cord level (ASIA Impairment Scale B, C, D, E)

Device: Brain-Computer Interface control of robotic arms with augmented reality; Device: Serious game with augmented reality

Healthy participants

ACTIVE COMPARATOR

Healthy participants, age and sex matched to the participants in the other two arms

Device: Brain-Computer Interface control of robotic arms with augmented reality; Device: Serious game with augmented reality

Interventions

Brain-Computer Interface control of robotic arms with augmented reality DEVICE

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.

Complete injury at cervical spine; Healthy participants; Incomplete Injury at cervical spine

Serious game with augmented reality DEVICE

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

Complete injury at cervical spine; Healthy participants; Incomplete Injury at cervical spine

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Laboratory of Medical Physics and Digital Innovation, AUTH

Thessaloniki, 54636, Greece

Location

Related Publications (1)

• Athanasiou A, Mitsopoulos K, Praftsiotis A, Astaras A, Antoniou P, Pandria N, Petronikolou V, Kasimis K, Lyssas G, Terzopoulos N, Fiska V, Kartsidis P, Savvidis T, Arvanitidis A, Chasapis K, Moraitopoulos A, Nizamis K, Kalfas A, Iakovidis P, Apostolou T, Magras I, Bamidis P. Neurorehabilitation Through Synergistic Man-Machine Interfaces Promoting Dormant Neuroplasticity in Spinal Cord Injury: Protocol for a Nonrandomized Controlled Trial. JMIR Res Protoc. 2022 Sep 13;11(9):e41152. doi: 10.2196/41152.

  PMID: 36099009 DERIVED

Related Links

• Study website

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Panos Bamidis, PhD

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alkinoos Athanasiou, PhD

CONTACT

+302310999237; athalkinoos@auth.gr

Panos Bamidis, PhD

CONTACT

bamidis@auth.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. PhD

Model Details: Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study (Parallel Assignement)

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 19, 2022
• Study Start: February 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)