BCI-Guided Tibialis Anterior FES for Gait Training in Spinal Cord Injury
Use of Brain Interface-Guided Functional Electrical Stimulation - Gait Training Machine in Individuals With Spinal Cord Injury
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Introduction:
Spinal Cord Injury (SCI) causes serious motor and sensory deficits, affecting thousands of people globally. Brain-Computer Interface (BCI) combined with Functional Electrical Stimulation (FES) emerges as a promising strategy to rehabilitate individuals with SCI. This mechanism will simultaneously stimulate the affected regions of the lower limbs, causing the compromised muscles to contract, causing movement. The FES technique, with its proven effectiveness in improving muscle strength, stands out as a crucial resource in this process of improving approaches integrated with advanced technology and physiotherapeutic principles to offer a promising perspective in neuromuscular rehabilitation.
Objective:
This study aims to investigate the effectiveness of Brain-Computer Interface (BCI)-guided Functional Electrical Stimulation (FES) in improving muscle activation and gait kinematics in individuals with Spinal Cord Injury (SCI).
Methodology:
This is a quasi-experimental study that will be conducted with four (n=4) volunteers with Spinal Cord Injury (age range: 18-60 years), of both sexes. Data collection will take place at the Edmond and Lily Safra International Institute of Neurosciences (IIN-ELS), Macaíba/RN, Brazil. For the characterization and eligibility of volunteers, the following instruments will be used: Modified Ashworth Scale, Douleur Neuropathique 4 questionnaire (DN4), and the Visual-10, Kinesthetic and Visual Imagery Questionnaire-10 (KVIQ-10). For clinical outcomes, the American Spinal Injury Association (ASIA), Spinal Cord Independence Measure - version III (SCIM-III), and the World Health Organization Quality of Life (WHOQOL-BREF) will be used. At the end of the protocol, the following questionnaires will be administered: System Usability Scale (SUS), Intrinsic Motivation Inventory (IMI), and Task Load Index (NASA-TLX) to assess system usability, intrinsic motivation, and perceived workload. The intervention will consist of 24 sessions aiming to use a brain-computer interface based on kinesthetic motor imagery of dorsiflexion associated with neurofeedback (visual and tactile), focused on the functional outcomes of individuals with paraplegia. During the intervention, volunteers will be instructed to imagine performing the dorsiflexion movement. An electroencephalogram (EEG) will be used to monitor brain activity through sensorimotor rhythms. When activity reaches a minimum threshold, functional electrical stimulation (FES) will be triggered, causing contraction of the tibialis anterior muscle.
Expected Results:
It is expected that BCI-guided FES targeting tibialis anterior muscle activation in individuals with SCI will contribute to the rehabilitation process by promoting improvements in neurological function, functional independence, and cortical activity. Changes are expected in clinical outcomes assessed by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI/ASIA) and the Spinal Cord Independence Measure III (SCIM III), as well as in EEG patterns associated with sensorimotor cortical activation. Furthermore, this innovative approach will not only provide improvements in the physical performance of individuals with SCI, but will also contribute to the continuous evolution of rehabilitation strategies, highlighting the fundamental role of technological advances in promoting the quality of life and autonomy of these individuals.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Rio Grande do Norte
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Macaíba, Rio Grande do Norte, Brasil, 59288-999
- Santos Dumont Institute
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Clinical diagnosis of traumatic spinal cord injury (SCI), classified as AIS grades A to D
- Male or female participants
- Age between 18 and 60 years
Exclusion Criteria:
- Skin lesions that preclude the use of functional electrical stimulation (FES)
- Lower-limb contractures that preclude the use of FES
- Lower-limb spasticity that precludes the use of FES
- Osteoporosis
- Recent surgical procedure
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Spinal Cord Injury
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The intervention protocol will last 26 min. The first 2 min are used to collect EEG data under baseline conditions, during which the participant does not perform mental tasks or receive electrical stimulation. Then there is 6 min of motor training with Neurofeedback (NFB). During this time, two 10s periods: one in which the FES devices are activated without motor imagery (MI), and another in which the FES is activated by the MI to induce movements in the feet. This includes six separate attempts for the right foot, left foot, and both feet, for a total of 18 attempts. After completing the NFB phase, the participant rests for 6 min to avoid mental and muscular fatigue. Subsequently, the user performs 12 min of training with BCI. This involves 20s intervals of MI to trigger the FES devices to dorsiflex the feet, followed by 20s rest periods. This cycle is repeated for a total of 18 exercises, six for each movement (right foot, left foot and both feet).
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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International Standards for Neurological Classification of Spinal Cord Injury
Periodo de tiempo: Baseline (before start of the intervention) At 12 week after baseline At 24 week after baseline
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The International Standards for Neurological Classification of Spinal Cord Injury/ASIA will be used to assess the neurological level and severity of spinal cord injury, including motor and sensory function.
The sensory score ranges from 0 (absent) to 2 (normal).
The ASIA sensory scores for light touch and pinprick are calculated by summing the scores across 28 dermatomes, with a total score ranging from 0 to 112 for each modality.
Higher scores indicate better sensory function.
Motor function will be assessed bilaterally using the 10 key muscles corresponding to the C5-T1 and L2-S1 myotomes.
Muscle strength is graded from 0 (total paralysis) to 5 (normal movement against maximum resistance).
The ASIA Lower Extremity Motor Score (LEMS; range 0-50) will be used to assess lower-extremity motor function, with higher scores indicating better motor function.
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Baseline (before start of the intervention) At 12 week after baseline At 24 week after baseline
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Spinal Cord Independence Measure III
Periodo de tiempo: Baseline (before start of the intervention) At 12 week after baseline At 24 week after baseline
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To assess functional independence in individuals with spinal cord injury.
The instrument evaluates self-care, respiration and sphincter management, and mobility.
The total Spinal Cord Independence Measure III score ranges from 0 to 100, with higher scores indicating greater levels of independence.
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Baseline (before start of the intervention) At 12 week after baseline At 24 week after baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Electroencephalography Analysis
Periodo de tiempo: Baseline (before start of the intervention); At 24 week after baseline.
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Verify the clinical effects and cortical activity of mu and beta rhythms through electroencephalography analysis.
Power Spectral Density (PSD) will be estimated using Welch's periodogram.
Mean power will be calculated across trials for the mu (8-12 Hz) and beta (18-24 Hz) frequency bands.
Power values will then be normalized to the mean power across the 8-30 Hz passband.
The percentage change in power during kinesthetic motor imagery relative to the resting condition will then be calculated.
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Baseline (before start of the intervention); At 24 week after baseline.
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System Usability Scale
Periodo de tiempo: At 24 week after baseline.
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To evaluate participants' perception and satisfaction in relation to the intervention protocol, using the System Usability Scale questionnaire, with the aim of identifying the most relevant and impactful aspects of the intervention for volunteers with SCI.
The final score ranges from 0 to 100, with scores above 68 indicating good system usability.
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At 24 week after baseline.
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World Health Organization Quality of Life
Periodo de tiempo: Baseline (before start of the intervention); At 12 week after baseline; At 24 week after baseline
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The World Health Organization Quality of Life-BREF will be used to assess participants' perceived quality of life.
The questionnaire evaluates four domains: physical health, psychological health, social relationships, and environment.
The raw domain score will be converted into a standardized score, ranging from 0 to 100, with a higher score indicating a better perceived quality of life.
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Baseline (before start of the intervention); At 12 week after baseline; At 24 week after baseline
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Task Load Index
Periodo de tiempo: At 24 week after baseline
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The Task Load Index will be used to assess participants' perceived workload during the intervention.
The questionnaire evaluates six dimensions: mental demand, physical demand, temporal demand, performance, effort, and frustration.
The sum of the weighted mean scores across these dimensions results in a total perceived workload score ranging from 0 to 100, classified as very low (0-20), low (21-40), moderate (41-60), high (61-80), and very high (81-100).
Higher scores indicate greater perceived workload.
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At 24 week after baseline
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Intrinsic Motivation Inventory
Periodo de tiempo: At 24 week after baseline.
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It consists of 10 items rated on a 7-point Likert scale, ranging from 1 to 7, with higher scores indicating greater motivation and reflecting the level of agreement or satisfaction regarding different aspects of the motivational experience.
The domains assessed include interest/enjoyment, effort/importance, and value/usefulness.
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At 24 week after baseline.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Douleur Neuropathique 4 questionnaire
Periodo de tiempo: Baseline (before start of the intervention).
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To identify the presence of neuropathic pain.
The score ranges from 0 to 10, with scores ≥4 indicating the presence of neuropathic pain.
For the eligibility criteria.
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Baseline (before start of the intervention).
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Kinesthetic and Visual Imagery Questionnaire-10
Periodo de tiempo: Baseline (before start of the intervention).
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To assess the volunteer's ability to generate and manipulate mental images.
The questionnaire score ranges from 0 to 25, with higher scores indicating greater motor imagery ability..
For the eligibility criteria.
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Baseline (before start of the intervention).
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Modified Ashworth Scale (MAS)
Periodo de tiempo: Baseline (before start of the intervention).
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To assess muscle spasticity, with scores ranging from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates severe spasticity, for eligibility assessment.
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Baseline (before start of the intervention).
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Heridas y Lesiones
- Trauma, Sistema Nervioso
- Enfermedades de la médula espinal
- Lesiones de la médula espinal
- Terapéutica
- Terapias de la mente-cuerpo
- Terapias complementarias
- Equipos y suministros
- Terapia conductual
- Psicoterapia
- Disciplinas y actividades de comportamiento
- Biofeedback, psicología
- Comentarios, psicológico
- Equipos y suministros eléctricos
- Neurofeedback
- Interfaces cerebro-computadora
Otros números de identificación del estudio
- 79344824.8.0000.0129
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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