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

Официальное название

Brain Information Transfer Dynamics and Neurorehabilitation Effects of a Virtual Reality-based Brain-Machine Interface Protocol in Spinal Cord Injury

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Neural Activity [Срок оценки: At each session, from enrollment to the end of participation, at approximately 6 weeks]
• ISNCSCI [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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).]

Вторичные конечные точки (4)

• Chronic Pain [Срок оценки: At each session, from enrollment to the end of the intervention, approximatly 6 weeks.]
• Intervention Side Effects [Срок оценки: At each session, from enrollment to the end of the intervention, approximatly 6 weeks.]
• Embodiment [Срок оценки: At each session, from enrollment to the end of the intervention, approximatly 6 weeks.]
• Independence Measure [Срок оценки: 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).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

Португалия · 2 центра

• Institute of Biomedicine (iBiMED), Department of Medical Sciences, University of Aveiro — Aveiro
• Centro de Reabilitação do Norte (CRN) Dr. Ferreira Alves, Unidade Local de Saúde de Gaia/E — Vila Nova de Gaia

Публикации

• 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
• 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

Идентификаторы

NCT: NCT07732868 · 16-CE-ICVS/CAC-EMHA/11.06.2024 · 2023.02051.BD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗