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

23 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rejestracja na zaproszenie

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

20

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: I - Complete SCI
Participants with complete SCI who undergo the BMI protocol plus the rehabilition center intervention
Urządzenie: 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.
Aktywny komparator: I - Incomplete SCI
Participants with incomplete SCI who undergo the BMI protocol plus the rehabilition center intervention
Urządzenie: 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.
Aktywny komparator: Able Bodied
Able body participants who undergo the BMI protocol
Urządzenie: 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.
Brak interwencji: NI - Complete SCI
Participants with complete SCI who only receives the rehabilition center intervention
Brak interwencji: NI - Incomplete SCI
Participants with incomplete SCI who only receives the rehabilition center intervention

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Neural Activity
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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).

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Chronic Pain
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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).

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
BMI Performance
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

José Gabriel da Silva Figueiredo

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

22 lipca 2025

Zakończenie podstawowe (Szacowany)

1 grudnia 2028

Ukończenie studiów (Szacowany)

1 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

20 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

23 lipca 2026

Pierwszy wysłany (Rzeczywisty)

29 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

29 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

23 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 16-CE-ICVS/CAC-EMHA/11.06.2024
  • 2023.02051.BD (Inny numer grantu/finansowania: Fundação para a Ciência e Tecnologia, I.P. (FCT))

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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