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RECRUITING Not applicable ClinicalTrials.gov

Cognitive Rehabilitation Using Neurofeedback With Brain-computer Interface

Sponsor: KK Women's and Children's Hospital • ClinicalTrials.gov ID: NCT07828496

Registry updated: 2026-09-18
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Description

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: 1. Can EEG-derived measures of sustained attention, relaxation, and selective attention detect and quantify cognitive impairment in children and adolescents following ABI? 2. 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.

Interventions

  • Brain-computer interface with neurofeedback with 3D game sessions (Other)
    12 sessions of BCI-NFT computer games over 10 weeks

Eligibility criteria

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

Conditions

Acquired Brain Injury Including Stroke Epilepsy

Locations

  • KK Women's and Children's Hospital — Singapore, Singapore
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record