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.
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
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.
- Conditions
- Spinal Cord Injuries
- 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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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 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.
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
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)
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
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
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
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
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.
- First posted19 Jul 2022
- Study start1 Feb 2027 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alkinoos Athanasiou, Aristotle University Of Thessaloniki
- Investigators
- Panos Bamidis, PhD, Principal investigator, Aristotle University Of Thessaloniki
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeuroSuitUp: Neurorehabilitation Through Synergistic Man-machine Intrefaces Promoting Dormant Neuroplasticity in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05465486
- Acronym / sponsor ID
- NeuroSuitUp / 249473/2019
- Conditions
- Spinal Cord Injuries
- Keywords
- Complete SCI, Chronic SCI, Incomplete SCI, Cervical Spine Injury, Neuroplasticity, Robotics, Wearables
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study (Parallel Assignement)
| Arm | Type | Receives |
|---|---|---|
| Complete injury at cervical spine | Experimental | Device: Brain-Computer Interface control of robotic arms with augmented reality, Device: Serious game with augmented realityPatients from Greece, 14 y.o. or oder, suffering from chronic complete injury at the cervical spinal cord level (ASIA Impairment Scale A) |
| Incomplete Injury at cervical spine | Experimental | Device: Brain-Computer Interface control of robotic arms with augmented reality, Device: Serious game with augmented realityPatients 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) |
| Healthy participants | Active comparator | Device: Brain-Computer Interface control of robotic arms with augmented reality, Device: Serious game with augmented realityHealthy participants, age and sex matched to the participants in the other two arms |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain-Computer Interface control of robotic arms with augmented realityThe 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. | Device | Complete injury at cervical spine, Healthy participants, Incomplete Injury at cervical spine |
| Serious game with augmented realityThe 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 | Device | Complete injury at cervical spine, Healthy participants, Incomplete Injury at cervical spine |
Primary outcome
BCI control (yes/no)
Time frame: Immediately after the intervention
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).
Serious game performance (in-game scoring system)
Time frame: Immediately after the intervention
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.
5 secondary outcomes
Initial Functional Improvement (Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III)
Time frame: 3 months after first participant in first session
Intermediate Functional Improvement (Greek translation of the Spinal Cord Independence Measure, version III (g-SCIM-III)
Time frame: 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)
Time frame: One year after first participant in first session
BCI performance classification accuracy
Time frame: 6 months after first participation in first session
BCI performance by bit rate
Time frame: 6 months after first participation in first session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Derived from this study: PubMed 36099009Athanasiou 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.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Panos Bamidis, PhD principal investigator
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
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.