Neurorehabilitation Through Synergistic Man-Machine Interfaces Promoting Dormant Neuroplasticity in Spinal Cord Injury: Protocol for a Nonrandomized Controlled Trial
Authors: Athanasiou Alkinoos , Mitsopoulos Konstantinos , Praftsiotis Apostolos , Astaras Alexander , Antoniou Panagiotis , Pandria Niki , Petronikolou Vasileia , Kasimis Konstantinos , Lyssas George , Terzopoulos Nikos , Fiska Vasilki , Kartsidis Panagiotis , Savvidis Theodoros , Arvanitidis Athanasios , Chasapis Konstantinos , Moraitopoulos Alexandros , Nizamis Kostas , Kalfas Anestis , Iakovidis Paris , Apostolou Thomas , Magras Ioannis , Bamidis Panagiotis 
Published: September 2022

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://clinicaltrials.gov/ct2/show/NCT05465486

International Registered Report Identifier (IRRID)
PRR1-10.2196/41152