Clinical trial NCT05465486: NeuroSuitUp: Neurorehabilitation Through Synergistic Man-machine Interfaces
Official title: NeuroSuitUp: Neurorehabilitation Through Synergistic Man-machine Intrefaces Promoting Dormant Neuroplasticity in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Complete SCI
Chronic SCI
Incomplete SCI
Cervical Spine Injury
Neuroplasticity
Robotics
Wearables
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study (Parallel Assignement)
Primary purpose: BASIC_SCIENCE

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.

Detailed description: NeuroSuitUp project's full title is \<Neurorehabilitation through synergistic man-machine intrefaces promoting dormant neuroplasticity in spinal cord injury\> . 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.

Eligibility criteria: 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

Primary outcomes:
measure: BCI control (yes/no)
timeFrame: Immediately after the intervention
measure: Serious game performance (in-game scoring system)
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Initial Functional Improvement (Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III)
timeFrame: 3 months after first participant in first session
measure: Intermediate Functional Improvement (Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III)
timeFrame: 6 months after first participant in first session
measure: Long-term Functional Improvement (Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III)
timeFrame: One year after first participant in first session
measure: BCI performance classification accuracy
timeFrame: 6 months after first participation in first session
measure: BCI performance by bit rate
timeFrame: 6 months after first participation in first session
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Laboratory of Medical Physics and Digital Innovation, AUTH
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Panos Bamidis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.