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Spinal Cord InjuriesNeuroSuitUpNCT05465486

NeuroSuitUp: Neurorehabilitation Through Synergistic Man-machine Interfaces

A study testing Serious game with augmented reality in people with Spinal Cord Injuries, run by Aristotle University Of Thessaloniki at 1 site in Greece.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 14 years and olderHealthy volunteers can take part
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Serious game with augmented reality
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteGreece
Study dates
1 Feb 2027to 28 Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Greece1 site
  • Laboratory of Medical Physics and Digital Innovation, AUTH

    Thessaloniki, 54636

Other trials in Greece

About this study

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

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.

Read the 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.

Being tested
Brain-Computer Interface control of robotic arms with augmented reality, Serious game with augmented reality
Keywords
Complete SCI, Chronic SCI, Incomplete SCI, Cervical Spine Injury, Neuroplasticity, Robotics, Wearables
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brain-Computer Interface control of robotic arms with augmented realityDevice

    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 realityDevice

    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

Study groups in NCT05465486
Study groupRoleWhat they receive
Complete injury at cervical spineExperimentalPatients from Greece, 14 y.o. or oder, suffering from chronic complete injury at the cervical spinal cord level (ASIA Impairment Scale A)
Receives: Device: Brain-Computer Interface control of robotic arms with augmented reality; Device: Serious game with augmented reality
Incomplete Injury at cervical spineExperimentalPatients 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)
Receives: Device: Brain-Computer Interface control of robotic arms with augmented reality; Device: Serious game with augmented reality
Healthy participantsActive comparatorHealthy participants, age and sex matched to the participants in the other two arms
Receives: Device: Brain-Computer Interface control of robotic arms with augmented reality; Device: Serious game with augmented reality

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Immediately after the intervention

  2. 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.

    Measured: Immediately after the intervention

Secondary outcomes (5)
  1. 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).

    Measured: 3 months after first participant in first session

  2. 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).

    Measured: 6 months after first participant in first session

  3. 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).

    Measured: One year after first participant in first session

  4. 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)

    Measured: 6 months after first participation in first session

  5. 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).

    Measured: 6 months after first participation in first session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2022
  2. Study start1 Feb 2027 (estimated)
  3. Primary completion28 Feb 2028 (estimated)
  4. Study completion28 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study (Parallel Assignement)
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05465486
Sponsor's protocol ID
249473/2019
Acronym
NeuroSuitUp
Status last verified
Oct 2026
First submitted
14 Jul 2022
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36099009

Questions about this trial

What is this clinical trial studying?

A study testing Serious game with augmented reality in people with Spinal Cord Injuries, run by Aristotle University Of Thessaloniki at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BCI control (yes/no) (time frame: Immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05465486, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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