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Effects of a Virtual Reality-based Brain-Machine Interface Protocol in Spinal Cord Injury

23 juillet 2026 mis à jour par: José Gabriel da Silva Figueiredo

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.

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.

Aperçu de l'étude

Statut

Inscription sur invitation

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

20

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Le Portugal
      • Aveiro, Le Portugal, 3810-193
        • Institute of Biomedicine (iBiMED), Department of Medical Sciences, University of Aveiro
      • Vila Nova de Gaia, Le Portugal, 4405-565
        • Centro de Reabilitação do Norte (CRN) Dr. Ferreira Alves, Unidade Local de Saúde de Gaia/Espinho

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: I - Complete SCI
Participants with complete SCI who undergo the BMI protocol plus the rehabilition center intervention
Dispositif: Brain-Machine Interface
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.
Comparateur actif: I - Incomplete SCI
Participants with incomplete SCI who undergo the BMI protocol plus the rehabilition center intervention
Dispositif: Brain-Machine Interface
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.
Comparateur actif: Able Bodied
Able body participants who undergo the BMI protocol
Dispositif: Brain-Machine Interface
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.
Aucune intervention: NI - Complete SCI
Participants with complete SCI who only receives the rehabilition center intervention
Aucune intervention: NI - Incomplete SCI
Participants with incomplete SCI who only receives the rehabilition center intervention

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Neural Activity
Délai: 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).
At each session, from enrollment to the end of participation, at approximately 6 weeks
ISNCSCI
Délai: 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.
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
Délai: 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.
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
Délai: 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.
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).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Chronic Pain
Délai: At each session, from enrollment to the end of the intervention, approximatly 6 weeks.
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.
At each session, from enrollment to the end of the intervention, approximatly 6 weeks.
Intervention Side Effects
Délai: At each session, from enrollment to the end of the intervention, approximatly 6 weeks.
Side effects will be measured through the Simulator Sickness Questionnaire.
At each session, from enrollment to the end of the intervention, approximatly 6 weeks.
Embodiment
Délai: At each session, from enrollment to the end of the intervention, approximatly 6 weeks.
Sense of embodiment towards the virtual avatar and comfort during the experince will be measured using an adaptation of the Embodiment Questionnaire.
At each session, from enrollment to the end of the intervention, approximatly 6 weeks.
Independence Measure
Délai: 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).
Independence will be measured using 4th version of the Spinal Cord Independence Measure (SCIM IV)
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).

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
BMI Performance
Délai: At each session, from enrollment to the end of the intervention, approximatly 6 weeks.
Brain-machine interface (BMI) classification performance will be measured and compared against neural data and participant reports.
At each session, from enrollment to the end of the intervention, approximatly 6 weeks.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

José Gabriel da Silva Figueiredo

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 juillet 2025

Achèvement primaire (Estimé)

1 décembre 2028

Achèvement de l'étude (Estimé)

1 décembre 2028

Dates d'inscription aux études

Première soumission

20 juillet 2026

Première soumission répondant aux critères de contrôle qualité

23 juillet 2026

Première publication (Réel)

29 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

29 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 16-CE-ICVS/CAC-EMHA/11.06.2024
  • 2023.02051.BD (Autre subvention/numéro de financement: Fundação para a Ciência e Tecnologia, I.P. (FCT))

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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