- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07828496
Cognitive Rehabilitation Using Neurofeedback With Brain-computer Interface
Cognitive Rehabilitation Using Neurofeedback With Brain-computer Interface - CONNECT: A Prospective Randomised Controlled Trial
The goal of this clinical trial is to determine whether a Brain-Computer Interface Neurofeedback Training (BCI-NFT) programme can improve cognitive outcomes, and whether electroencephalography (EEG)-based measures can serve as objective markers of cognitive impairment, in children and adolescents aged 7 to 21 years with acquired brain injury (ABI), including traumatic brain injury (TBI), stroke, encephalitis, brain tumour, or epilepsy.
A group of children and adolescents aged 7 to 21 years without any history of brain injury or epilepsy will also be enrolled to provide normative EEG data for comparison.
The main questions the study aims to answer are:
- Can EEG-derived measures of sustained attention, relaxation, and selective attention detect and quantify cognitive impairment in children and adolescents following ABI?
- Does a structured BCI-NFT programme improve cognitive and behavioural outcomes, including attention, memory, and executive function, compared with standard care alone?
Researchers will compare an Intervention Group, who will receive BCI-NFT in addition to standard cognitive rehabilitation, with a Waitlist-Control Group, who will initially receive standard care alone before subsequently crossing over to receive BCI-NFT. This design will allow researchers to determine whether BCI-NFT leads to greater improvements in cognitive and behavioural outcomes compared with standard care alone.
Participants in the main ABI cohort will:
- Complete behavioural assessments using the Behavior Assessment System for Children, Third Edition (BASC-3), including parent and/or teacher reports.
- Complete 12 BCI-NFT sessions over a 10-week period. Each session will last approximately 60 minutes. During each session, participants will wear a wireless EEG headset and interact with neurofeedback computer games designed to respond to their sustained attention, selective attention, and response time.
- Repeat the BASC-3 behavioural assessments at the end of the study period.
- Have undergone a recent neuropsychological assessment within the preceding 2 years and ongoing review by a neuropsychologist.
Participants in the normative EEG cohort, comprising children and adolescents without a history of brain injury or epilepsy, will attend a single study session. During this session, EEG activity will be recorded both at rest and while participants interact with a three-dimensional (3D) computer game. These recordings will provide normative EEG data against which findings from participants with ABI can be compared.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jia Hui Teo
- Número de teléfono: +6563926042
- Correo electrónico: teo.jia.hui@singhealth.com.sg
Ubicaciones de estudio
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Singapore, Singapur
- Reclutamiento
- KK Women's and Children's Hospital
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Contacto:
- Jia Hui Teo, MBBS
- Número de teléfono: +6563926042
- Correo electrónico: teo.jia.hui@singhealth.com.sg
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Contacto:
- Nabil
- Número de teléfono: 6563947254
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Normaitve cohort:
- Patients with no history of epilepsy
Inclusion Criteria:
- Post acquired brain injury (stroke, encephalitis, brain tumour, traumatic brain injury)
- Epilepsy
Exclusion Criteria:
- History of photosensitive seizures
- Diagnosis of intellectual disability
- Presence of psychotic symptoms
- Diagnosis of attention deficit and hyperactivity disorder
- Diagnosis of autism spectrum disorder
- Children on methylphenidate
- Children who are unable to cooperate with neuropsychological assessment of cognitive function
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: BCI
Intervention then standard of care
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12 sessions of BCI-NFT computer games over 10 weeks
Otros nombres:
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Experimental: Usual care
Usual care followed by intervention
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12 sessions of BCI-NFT computer games over 10 weeks
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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Change in Attention Threshold
Periodo de tiempo: Baseline (Session 1) to final session (Session 12), over 10 weeks
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Change in the game's adaptive attention threshold value, measured at each session, on a normalised scale between 0 to 1, where the greater value indicates greater sustained attention.
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Baseline (Session 1) to final session (Session 12), over 10 weeks
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Change in Relaxation Threshold
Periodo de tiempo: Baseline (Session 1) to final session (Session 12), over 10 weeks
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Change in the game's adaptive threshold value, measured at each session, according to the normalised scale between 0 and 1, where higher value means greater sustained relaxation.
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Baseline (Session 1) to final session (Session 12), over 10 weeks
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Change in Response Time
Periodo de tiempo: Baseline (Session 1) to final session (Session 12), over 10 weeks
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Change in mean response time to in-game stimuli, measured in milliseconds, at each session.
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Baseline (Session 1) to final session (Session 12), over 10 weeks
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Change in Alpha-Lateralization Index
Periodo de tiempo: Baseline (Session 1) to final session (Session 12), over 10 weeks
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Change in the alpha-lateralization index, a unitless measure derived from posterior EEG channels (P7/P8, O1/O2), ranging from -1 to +1, measured at each session.
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Baseline (Session 1) to final session (Session 12), over 10 weeks
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Change in Beta-to-Alpha Power Ratio
Periodo de tiempo: Baseline (Session 1) to final session (Session 12), over 10 weeks
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Change in the ratio of EEG beta-band to alpha-band spectral power, a unitless ratio, measured at each session.
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Baseline (Session 1) to final session (Session 12), over 10 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Internalising problem score on Behavior Assessment System for Children, Third Edition (BASC-3)
Periodo de tiempo: From enrollment to 20 weeks
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Total internalising symptoms (anxiety, depression, somatisation) on BASC-3 questionnaire.
T-scores for the BASC-3 Internalizing Problems composite range from a minimum of 20 to a maximum of 120.
Higher scores indicate greater severity of mood disorder.
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From enrollment to 20 weeks
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Externalising symptoms score in Behavior Assessment System for Children, Third Edition (BASC-3)
Periodo de tiempo: From enrollment to end of study 20 weeks
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Degree of change in total score for externalising symptoms (Hyperactivity, aggression, conduct problems) in BASC-3 questionnaire.
Raw score will be converted to T-score with range from 20 to 120.
Higher score suggests a high level of maladjustment or severe impairment
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From enrollment to end of study 20 weeks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
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
Términos MeSH relevantes adicionales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Epilepsia
- 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
- 2024/2114
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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