Spinal Cord InjuryNCT07732868
Effects of a Virtual Reality-based Brain-Machine Interface Protocol in Spinal Cord Injury
A study testing Brain-Machine Interface in people with Spinal Cord Injury and Able Bodied, run by José Gabriel da Silva Figueiredo at 2 sites in Portugal.
Trial summary
Spinal cord injury (SCI) is a highly debilitating pathology, associated with the loss of sensorimotor functions, autonomy and quality of life. Although there is currently no cure, brain-machine interfaces (BMI) have been used as a method of SCI rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury, Able Bodied, Traumatic Spinal Cord Injuries
- What is being tested?
- Brain-Machine Interface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesPortugal
- Study dates
- 22 Jul 2025to Dec 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any gender
- Age between 18 and 65
- Able to follow instructions and communicate verbally in Portuguese (or english for able bodied volunteers)
- For the spinal cord injury group:
- American Spinal Injury Association - ASIA - Impairment Scale (AIS) grade A, B, or C
- Traumatic
- Subacute condition
- With upper limb dexterity to manipulate virtual reality controlers
Who cannot join
- Pregnant/breastfeeding women
- Disability/neurological condition that may interfere with tasks or measurements (e.g., cognitive impairment, dementia, brain injury)
- Physical injury that prevents the use of the equipment (e.g., limb amputation)
- History of severe psychiatric illness
- Inability to decide autonomously
- Conditioned binocular vision
- Photosensitive epilepsy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal2 sites
Institute of Biomedicine (iBiMED), Department of Medical Sciences, University of Aveiro
Aveiro, 3810-193
Centro de Reabilitação do Norte (CRN) Dr. Ferreira Alves, Unidade Local de Saúde de Gaia/Espinho
Vila Nova de Gaia, 4405-565
About this study
Official title: Brain Information Transfer Dynamics and Neurorehabilitation Effects of a Virtual Reality-based Brain-Machine Interface Protocol in Spinal Cord Injury
Spinal cord injury (SCI) is a highly debilitating pathology, associated with the loss of sensorimotor functions, autonomy and quality of life. Although there is currently no cure, brain-machine interfaces (BMI) have been used as a method of SCI rehabilitation. BMIs use neurophysiological signals recorded by techniques such as electroencephalography (EEG) to produce a response in a device. Recently, BMIs have achieved clinically relevant improvements in several neuropathologies. However, the biological basis of these therapeutic protocols is yet to be studied, which is extremely important to improve their effectiveness.
Therefore, in this study it is applyed an improved BMI protocol by combination with virtual reality (VR), sensory feedback (visual, auditory, and tactile), and/or exoskeleton to characterize in detail the dynamics of information transfer between the various participants' brain regions (primary objective of the overall study, which involves participants with and without SCI), and improve the rehabilitation of SCI patients. For this, the neurophysiological signals obtained by EEG will be studied, with particular interest in the altered activity that correlates with relevant clinical improvements in the rehabilitation of SCI patients.
Read more
At the beginning of the study, the following data will be collected from the participant: age, gender; specifically for participants with SCI, data associated with the injury will also be collected; level and type of injury, time post-injury, functional classification, neurological manifestations, e.g. neuropathic pain.
During the study, the participant will be monitored weekly in a total of 12 sessions, each with an expected duration of one to two hours. In these sessions, the participant will perform a 'BMI protocol': they will move a virtual avatar using motor imagery (thinking about movement) in VR, with sensory feedback provided by VR equipment and tactile sleeves. Participants without SCI will also be able to wear an exoskeleton (ExoAtlet). The VR software was developed by the research group and is locally installed on a computer for exclusive use for the implementation of this BMI protocol. It is important to note that the software operates without a network connection and does not collect any type of personal data. The participants' brain activity will be recorded by the non-invasive EEG technique, while the participant is performing the BMI protocol, in which they will have to perform mental tasks such as walking and resting. Each session has three blocks: a first one for the participant's familiarization with the virtual scenario and/or exoskeleton; and the rest to train and carry out the tasks.
At the end, questionnaires will be carried out to assess comfort or possible undesirable effects during the VR experience (e.g., fatigue or nausea) and the participant will be given the opportunity to report their experience during the session. The EEG data from subsequent sessions will be analyzed and compared over time to identify changes in the participants' brain activity promoted by this rehabilitation protocol. Blood samples will also be collected at the beginning and end of the study (1st and 12th session), to evaluate molecules potentially associated with rehabilitation. These samples, anonymized at the end of their participation in this study, will be preserved in the Institute of Biomedicine (iBiMED, University of Aveiro) Biobank for 20 years, under the responsibility of the principal investigators, to be used in the present study. Their samples and anonymized data may be used in other future studies of the same scope, but such use will always require consent from the responsible ethics committee.
Participants with SCI will be asked about the evolution of neuropathic pain (if any) with different pain scales. At the beginning and end of the study (1st and 12th session), the standard neurological and functional classification of the lesion will be performed by physicians/therapists, according to the rehabilitation center's routine. Three months after being discharged from the center, during the revisit consultation, the clinical data described here will be collected again.
- Being tested
- Brain-Machine Interface
- Medical subject headings
- Spinal Cord Injuries, Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain-Machine InterfaceDevice
The participants will perform a virtual reality (VR)-based brain-machine interface (BMI) protocol: they will move a virtual avatar using motor imagery (thinking about movement) in an immersive VR, with sensory feedback provided by VR equipment and thermo-tactile sleeves. The VR software was developed by the research group and is locally installed on a computer for exclusive use for the implementation of this BMI protocol. The participants will have to perform tasks such as walking and resting in the virtual environment according to a presented visual cue. Each session has three blocks: a first one for the participant's familiarization with the virtual scenario; and the remaining to train and carry out the tasks.
| Study group | Role | What they receive |
|---|---|---|
| I - Complete SCI | Active comparator | Participants with complete SCI who undergo the BMI protocol plus the rehabilition center intervention Receives: Device: Brain-Machine Interface |
| I - Incomplete SCI | Active comparator | Participants with incomplete SCI who undergo the BMI protocol plus the rehabilition center intervention Receives: Device: Brain-Machine Interface |
| Able Bodied | Active comparator | Able body participants who undergo the BMI protocol Receives: Device: Brain-Machine Interface |
| NI - Complete SCI | No intervention | Participants with complete SCI who only receives the rehabilition center intervention |
| NI - Incomplete SCI | No intervention | Participants with incomplete SCI who only receives the rehabilition center intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural Activity
Neural activity will be recorded with 16-channel electroencephalography (EEG) throughout the sessions to describe its evolution in response to the intervention (brain-machine interface protocol).
Measured: At each session, from enrollment to the end of participation, at approximately 6 weeks
ISNCSCI
Measurement of the sensorimotor function at the beginning and at the end.
Measured: Outcome assessed upon admission at the rehabilitation center and re-assessed after up to 12 weeks at discharge. Discharge from the center depends on the patient's individual circumstances (e.g., individual progression, heath facilty transfer).
Slot Blot/ELISA for Targeted Molecular Analysis
Biologic samples (e.g., blood, saliva, urine, etc.) will be collected at enrollment and completion of participation in the study (see Time Frame). They will be processed and targeted molecular markers will be quantified using tools, such as Slot Blot and Ezyme-Linked Immunosorbent Assay (ELISA), to be correlated with the other neural and clinical outcomes.
Measured: Outcome assessed upon enrollment in the study and re-assessed after up to 12 weeks at completion of participation. Completion depends on the patient's individual circumstances (e.g., complications from any cause).
FTIR for Untargeted Molecular Analysis
Biologic samples (e.g., blood, saliva, urine, etc.) will be collected at enrollment and completion of participation in the study (see Time Frame). They will be processed and Fourier Transform-Infrared (FTIR) spectroscopy will be used to discover novel molecular markers of rehabilitation.
Measured: Outcome assessed upon enrollment in the study and re-assessed after up to 12 weeks at completion of participation. Completion depends on the patient's individual circumstances (e.g., complications from any cause).
Secondary outcomes (4)
Chronic Pain
If present, chronic pain (either nociceptive or neurophatic) will be evaluated through four different scales: visual analog scale (VAS), numerical rating scale (NRS), verbal pain scale, and faces pain scale. Non-numerical assessments (i.e., verbal and faces pain scales) will be then converted to numbers in order to report the average pain score.
Measured: At each session, from enrollment to the end of the intervention, approximatly 6 weeks.
Intervention Side Effects
Side effects will be measured through the Simulator Sickness Questionnaire.
Measured: At each session, from enrollment to the end of the intervention, approximatly 6 weeks.
Embodiment
Sense of embodiment towards the virtual avatar and comfort during the experince will be measured using an adaptation of the Embodiment Questionnaire.
Measured: At each session, from enrollment to the end of the intervention, approximatly 6 weeks.
Independence Measure
Independence will be measured using 4th version of the Spinal Cord Independence Measure (SCIM IV)
Measured: Outcome assessed upon admission at the rehabilitation center and re-assessed after up to 12 weeks at discharge. Discharge from the center depends on the patient's individual circumstances (e.g., individual progression, heath facilty transfer).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start22 Jul 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- José Gabriel da Silva Figueiredo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, José Gabriel da Silva Figueiredo, Aveiro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732868
- Sponsor's protocol ID
- 16-CE-ICVS/CAC-EMHA/11.06.2024
- Other IDs
- 2023.02051.BD, 2023
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pais-Vieira C, Figueiredo JG, Perrotta A, Matos D, Aguiar M, Ramos J, Gato M, Poleri T, Pais-Vieira M. Activation of a Rhythmic Lower Limb Movement Pattern during the Use of a Multimodal Brain-Computer Interface: A Case Study of a Clinically Complete Spinal Cord Injury. Life (Basel). 2024 Mar 16;14(3):396. doi: 10.3390/life14030396.
PubMed 38541720Pais-Vieira C, Gaspar P, Matos D, Alves LP, da Cruz BM, Azevedo MJ, Gago M, Poleri T, Perrotta A, Pais-Vieira M. Embodiment Comfort Levels During Motor Imagery Training Combined With Immersive Virtual Reality in a Spinal Cord Injury Patient. Front Hum Neurosci. 2022 May 20;16:909112. doi: 10.3389/fnhum.2022.909112. eCollection 2022.
PubMed 35669203
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Information Transfer Dynamics and Neurorehabilitation Effects of a Virtual Reality-based Brain-Machine Interface Protocol in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07732868
- Acronym / sponsor ID
- 16-CE-ICVS/CAC-EMHA/11.06.2024
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- José Gabriel da Silva FigueiredoUniversity, hospital or other
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Jul 2026 (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.
Spinal cord injury (SCI) is a highly debilitating pathology, associated with the loss of sensorimotor functions, autonomy and quality of life. Although there is currently no cure, brain-machine interfaces (BMI) have been used as a method of SCI rehabilitation. BMIs use neurophysiological signals recorded by techniques such as electroencephalography (EEG) to produce a response in a device. Recently, BMIs have achieved clinically relevant improvements in several neuropathologies. However, the biological basis of these therapeutic protocols is yet to be studied, which is extremely important to improve their effectiveness.
Therefore, in this study it is applyed an improved BMI protocol by combination with virtual reality (VR), sensory feedback (visual, auditory, and tactile), and/or exoskeleton to characterize in detail the dynamics of information transfer between the various participants' brain regions (primary objective of the overall study, which involves participants with and without SCI), and improve the rehabilitation of SCI patients. For this, the neurophysiological signals obtained by EEG will be studied, with particular interest in the altered activity that correlates with relevant clinical improvements in the rehabilitation of SCI patients.
At the beginning of the study, the following data will be collected from the participant: age, gender; specifically for participants with SCI, data associated with the injury will also be collected; level and type of injury, time post-injury, functional classification, neurological manifestations, e.g. neuropathic pain.
During the study, the participant will be monitored weekly in a total of 12 sessions, each with an expected duration of one to two hours. In these sessions, the participant will perform a 'BMI protocol': they will move a virtual avatar using motor imagery (thinking about movement) in VR, with sensory feedback provided by VR equipment and tactile sleeves. Participants without SCI will also be able to wear an exoskeleton (ExoAtlet). The VR software was developed by the research group and is locally installed on a computer for exclusive use for the implementation of this BMI protocol. It is important to note that the software operates without a network connection and does not collect any type of personal data. The participants' brain activity will be recorded by the non-invasive EEG technique, while the participant is performing the BMI protocol, in which they will have to perform mental tasks such as walking and resting. Each session has three blocks: a first one for the participant's familiarization with the virtual scenario and/or exoskeleton; and the rest to train and carry out the tasks.
At the end, questionnaires will be carried out to assess comfort or possible undesirable effects during the VR experience (e.g., fatigue or nausea) and the participant will be given the opportunity to report their experience during the session. The EEG data from subsequent sessions will be analyzed and compared over time to identify changes in the participants' brain activity promoted by this rehabilitation protocol. Blood samples will also be collected at the beginning and end of the study (1st and 12th session), to evaluate molecules potentially associated with rehabilitation. These samples, anonymized at the end of their participation in this study, will be preserved in the Institute of Biomedicine (iBiMED, University of Aveiro) Biobank for 20 years, under the responsibility of the principal investigators, to be used in the present study. Their samples and anonymized data may be used in other future studies of the same scope, but such use will always require consent from the responsible ethics committee.
Participants with SCI will be asked about the evolution of neuropathic pain (if any) with different pain scales. At the beginning and end of the study (1st and 12th session), the standard neurological and functional classification of the lesion will be performed by physicians/therapists, according to the rehabilitation center's routine. Three months after being discharged from the center, during the revisit consultation, the clinical data described here will be collected again.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| I - Complete SCI | Active comparator | Device: Brain-Machine InterfaceParticipants with complete SCI who undergo the BMI protocol plus the rehabilition center intervention |
| I - Incomplete SCI | Active comparator | Device: Brain-Machine InterfaceParticipants with incomplete SCI who undergo the BMI protocol plus the rehabilition center intervention |
| Able Bodied | Active comparator | Device: Brain-Machine InterfaceAble body participants who undergo the BMI protocol |
| NI - Complete SCI | No intervention | –Participants with complete SCI who only receives the rehabilition center intervention |
| NI - Incomplete SCI | No intervention | –Participants with incomplete SCI who only receives the rehabilition center intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Any gender
- Age between 18 and 65
- Able to follow instructions and communicate verbally in Portuguese (or english for able bodied volunteers)
- For the spinal cord injury group:
Key exclusion criteria (7 listed)
- Pregnant/breastfeeding women
- Disability/neurological condition that may interfere with tasks or measurements (e.g., cognitive impairment, dementia, brain injury)
- Physical injury that prevents the use of the equipment (e.g., limb amputation)
- History of severe psychiatric illness
- Inability to decide autonomously
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-Machine InterfaceThe participants will perform a virtual reality (VR)-based brain-machine interface (BMI) protocol: they will move a virtual avatar using motor imagery (thinking about movement) in an immersive VR, with sensory feedback provided by VR equipment and thermo-tactile sleeves. The VR software was developed by the research group and is locally installed on a computer for exclusive use for the implementation of this BMI protocol. The participants will have to perform tasks such as walking and resting in the virtual environment according to a presented visual cue. Each session has three blocks: a first one for the participant's familiarization with the virtual scenario; and the remaining to train and carry out the tasks. | Device | Able Bodied, I - Complete SCI, I - Incomplete SCI |
Primary outcome
Neural Activity
Time frame: At each session, from enrollment to the end of participation, at approximately 6 weeks
Neural activity will be recorded with 16-channel electroencephalography (EEG) throughout the sessions to describe its evolution in response to the intervention (brain-machine interface protocol).
ISNCSCI
Time frame: Outcome assessed upon admission at the rehabilitation center and re-assessed after up to 12 weeks at discharge. Discharge from the center depends on the patient's individual circumstances (e.g., individual progression, heath facilty transfer).
Measurement of the sensorimotor function at the beginning and at the end.
Slot Blot/ELISA for Targeted Molecular Analysis
Time frame: Outcome assessed upon enrollment in the study and re-assessed after up to 12 weeks at completion of participation. Completion depends on the patient's individual circumstances (e.g., complications from any cause).
Biologic samples (e.g., blood, saliva, urine, etc.) will be collected at enrollment and completion of participation in the study (see Time Frame). They will be processed and targeted molecular markers will be quantified using tools, such as Slot Blot and Ezyme-Linked Immunosorbent Assay (ELISA), to be correlated with the other neural and clinical outcomes.
FTIR for Untargeted Molecular Analysis
Time frame: Outcome assessed upon enrollment in the study and re-assessed after up to 12 weeks at completion of participation. Completion depends on the patient's individual circumstances (e.g., complications from any cause).
Biologic samples (e.g., blood, saliva, urine, etc.) will be collected at enrollment and completion of participation in the study (see Time Frame). They will be processed and Fourier Transform-Infrared (FTIR) spectroscopy will be used to discover novel molecular markers of rehabilitation.
4 secondary outcomes
Chronic Pain
Time frame: At each session, from enrollment to the end of the intervention, approximatly 6 weeks.
Intervention Side Effects
Time frame: At each session, from enrollment to the end of the intervention, approximatly 6 weeks.
Embodiment
Time frame: At each session, from enrollment to the end of the intervention, approximatly 6 weeks.
Independence Measure
Time frame: Outcome assessed upon admission at the rehabilitation center and re-assessed after up to 12 weeks at discharge. Discharge from the center depends on the patient's individual circumstances (e.g., individual progression, heath facilty transfer).
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 29 Jul 2026.
- Background: PubMed 38541720Pais-Vieira C, Figueiredo JG, Perrotta A, Matos D, Aguiar M, Ramos J, Gato M, Poleri T, Pais-Vieira M. Activation of a Rhythmic Lower Limb Movement Pattern during the Use of a Multimodal Brain-Computer Interface: A Case Study of a Clinically Complete Spinal Cord Injury. Life (Basel). 2024 Mar 16;14(3):396. doi: 10.3390/life14030396.
- Background: PubMed 35669203Pais-Vieira C, Gaspar P, Matos D, Alves LP, da Cruz BM, Azevedo MJ, Gago M, Poleri T, Perrotta A, Pais-Vieira M. Embodiment Comfort Levels During Motor Imagery Training Combined With Immersive Virtual Reality in a Spinal Cord Injury Patient. Front Hum Neurosci. 2022 May 20;16:909112. doi: 10.3389/fnhum.2022.909112. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain-Machine Interface in people with Spinal Cord Injury and Able Bodied, run by José Gabriel da Silva Figueiredo at 2 sites in Portugal.
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 8 inclusion and 7 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 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. 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?
Neural Activity (time frame: At each session, from enrollment to the end of participation, at approximately 6 weeks). The study lists 4 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 NCT07732868, which also lists 2 linked publications.
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 29 Jul 2026.