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

NCT07732868 | Enrolling By Invitation DMC

• 2 other identifiers: 16-CE-ICVS/CAC-EMHA/11.06.20242023.02051.BD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Spinal Cord Injury; Able Bodied; Traumatic Spinal Cord Injuries; Paraplegia, Spinal

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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.

  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.

  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

  At each session, from enrollment to the end of the intervention, approximatly 6 weeks.

• Intervention Side Effects

  At each session, from enrollment to the end of the intervention, approximatly 6 weeks.

• Embodiment

  At each session, from enrollment to the end of the intervention, approximatly 6 weeks.

• Independence Measure

  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).

Other Outcomes (1)

• BMI Performance

  At each session, from enrollment to the end of the intervention, approximatly 6 weeks.

Study Arms (5)

I - Complete SCI

ACTIVE COMPARATOR

Participants with complete SCI who undergo the BMI protocol plus the rehabilition center intervention

Device: Brain-Machine Interface

I - Incomplete SCI

ACTIVE COMPARATOR

Participants with incomplete SCI who undergo the BMI protocol plus the rehabilition center intervention

Device: Brain-Machine Interface

Able Bodied

ACTIVE COMPARATOR

Able body participants who undergo the BMI protocol

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

Interventions

Brain-Machine Interface DEVICE

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.

Able Bodied; I - Complete SCI; I - Incomplete SCI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• José Gabriel da Silva Figueiredo: lead

Study Sites (2)

Institute of Biomedicine (iBiMED), Department of Medical Sciences, University of Aveiro

Aveiro, 3810-193, Portugal

Location

Centro de Reabilitação do Norte (CRN) Dr. Ferreira Alves, Unidade Local de Saúde de Gaia/Espinho

Vila Nova de Gaia, 4405-565, Portugal

Location

Related Publications (2)

• 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.

  PMID: 38541720 BACKGROUND

• Pais-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.

  PMID: 35669203 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia

Interventions

Brain-Computer Interfaces

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 29, 2026
• Study Start: July 22, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

PT (2)