Neurorehabilitation Through Synergistic Man-Machine Interfaces Promoting Dormant Neuroplasticity in Spinal Cord Injury: Protocol for a Nonrandomized Controlled Trial

Alkinoos Athanasiou, Konstantinos Mitsopoulos, Apostolos Praftsiotis, Alexander Astaras, Panagiotis Antoniou, Niki Pandria, Vasileia Petronikolou, Konstantinos Kasimis, George Lyssas, Nikos Terzopoulos, Vasilki Fiska, Panagiotis Kartsidis, Theodoros Savvidis, Athanasios Arvanitidis, Konstantinos Chasapis, Alexandros Moraitopoulos, Kostas Nizamis, Anestis Kalfas, Paris Iakovidis, Thomas Apostolou, Ioannis Magras, Panagiotis Bamidis, Alkinoos Athanasiou, Konstantinos Mitsopoulos, Apostolos Praftsiotis, Alexander Astaras, Panagiotis Antoniou, Niki Pandria, Vasileia Petronikolou, Konstantinos Kasimis, George Lyssas, Nikos Terzopoulos, Vasilki Fiska, Panagiotis Kartsidis, Theodoros Savvidis, Athanasios Arvanitidis, Konstantinos Chasapis, Alexandros Moraitopoulos, Kostas Nizamis, Anestis Kalfas, Paris Iakovidis, Thomas Apostolou, Ioannis Magras, Panagiotis Bamidis

Abstract

Background: Spinal cord injury (SCI) constitutes a major sociomedical problem, impacting approximately 0.32-0.64 million people each year worldwide; particularly, it impacts young individuals, causing long-term, often irreversible disability. While effective rehabilitation of patients with SCI remains a significant challenge, novel neural engineering technologies have emerged to target and promote dormant neuroplasticity in the central nervous system.

Objective: This study aims to develop, pilot test, and optimize a platform based on multiple immersive man-machine interfaces offering rich feedback, including (1) visual motor imagery training under high-density electroencephalographic recording, (2) mountable robotic arms controlled with a wireless brain-computer interface (BCI), (3) a body-machine interface (BMI) consisting of wearable robotics jacket and gloves in combination with a serious game (SG) application, and (4) an augmented reality module. The platform will be used to validate a self-paced neurorehabilitation intervention and to study cortical activity in chronic complete and incomplete SCI at the cervical spine.

Methods: A 3-phase pilot study (clinical trial) was designed to evaluate the NeuroSuitUp platform, including patients with chronic cervical SCI with complete and incomplete injury aged over 14 years and age-/sex-matched healthy participants. Outcome measures include BCI control and performance in the BMI-SG module, as well as improvement of functional independence, while also monitoring neuropsychological parameters such as kinesthetic imagery, motivation, self-esteem, depression and anxiety, mental effort, discomfort, and perception of robotics. Participant enrollment into the main clinical trial is estimated to begin in January 2023 and end by December 2023.

Results: A preliminary analysis of collected data during pilot testing of BMI-SG by healthy participants showed that the platform was easy to use, caused no discomfort, and the robotics were perceived positively by the participants. Analysis of results from the main clinical trial will begin as recruitment progresses and findings from the complete analysis of results are expected in early 2024.

Conclusions: Chronic SCI is characterized by irreversible disability impacting functional independence. NeuroSuitUp could provide a valuable complementary platform for training in immersive rehabilitation methods to promote dormant neural plasticity.

Trial registration: ClinicalTrials.gov NCT05465486; https://ichgcp.net/clinical-trials-registry/NCT05465486.

International registered report identifier (irrid): PRR1-10.2196/41152.

Keywords: body-machine interface; brain-computer interface; neural rehabilitation; serious games; spinal cord injury; wearable robotics.

Conflict of interest statement

Conflicts of Interest: None declared.

©Alkinoos Athanasiou, Konstantinos Mitsopoulos, Apostolos Praftsiotis, Alexander Astaras, Panagiotis Antoniou, Niki Pandria, Vasileia Petronikolou, Konstantinos Kasimis, George Lyssas, Nikos Terzopoulos, Vasilki Fiska, Panagiotis Kartsidis, Theodoros Savvidis, Athanasios Arvanitidis, Konstantinos Chasapis, Alexandros Moraitopoulos, Kostas Nizamis, Anestis Kalfas, Paris Iakovidis, Thomas Apostolou, Ioannis Magras, Panagiotis Bamidis. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.09.2022.

Figures

Figure 1
Figure 1
VMI under high-resolution EEG recording during presentation of multiple movements of the upper limb by patients with spinal cord injury in previous pilot experiment [3,16]. Figure from [16]. EEG: electroencephalography; VMI: visual motor imagery.
Figure 2
Figure 2
Pilot use of 8-degrees-of-freedom robotic arms by a 30-year-old patient with spinal cord injury with C6 tetraparesis, controlled by a commercial EEG-based brain-computer interface (Emotiv) through KMI [16,17]. Figure from [16]. EEG: electroencephalography; KMI: kinesthetic motor imagery.
Figure 3
Figure 3
(A) Schematic of sensors layer and photo of the wearable prototype. (B) Unity game snapshot and corresponding pose in the robot operating system (ROS) rviz tool. Figure modified from [18]. EMG: electromyography; EMS: electrical muscle stimulation; sEMG: surface electromyography.
Figure 4
Figure 4
Overview of the experimental procedures, based around 3 phases (initial, intermediate, and final assessments). AI: artificial intelligence; AR: augmented reality; BCI: brain-computer interface; fMRI: functional magnetic resonance imaging; HD EEG: high-density electroencephalography; VRE: virtual reality environment.
Figure 5
Figure 5
Answers of test trials participants to SMEQ. Size of the circles denotes relative number of answers. Red circle denotes median marking. SMEQ: Subjective Mental Effort Questionnaire.
Figure 6
Figure 6
All answers of test trials participants to the Locally Experienced Discomfort Questionnaire according to body area. Color inside the circles corresponds to complain intensity according to colormap.
Figure 7
Figure 7
(A) Mean Godspeed robotics questionnaire scores by category. (B) Total Godspeed scores of all participants in the test trials.

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