Able Bodied, Paraplegia, Spinal, Spinal Cord Injury, Traumatic Spinal Cord Injuries
Conditions
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.
Interventions
DEVICEBrain-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.
Sponsors
José Gabriel da Silva Figueiredo
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neural Activity | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic Pain | 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. |
| Intervention Side Effects | At each session, from enrollment to the end of the intervention, approximatly 6 weeks. | Side effects will be measured through the Simulator Sickness Questionnaire. |
| Embodiment | 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. |
| 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). | Independence will be measured using 4th version of the Spinal Cord Independence Measure (SCIM IV) |
Countries
Portugal
Outcome results
None listed