RecruitingNot ApplicableNCT07828496

Cognitive Rehabilitation Using Neurofeedback With Brain-computer Interface

Cognitive Rehabilitation Using Neurofeedback With Brain-computer Interface - CONNECT: A Prospective Randomised Controlled Trial


Sponsor

KK Women's and Children's Hospital

Enrollment

70 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 7 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Brain-computer interface with neurofeedback with 3D game sessions for people with acquired brain injury (including stroke) and epilepsy. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBrain-computer interface with neurofeedback with 3D game sessions

12 sessions of BCI-NFT computer games over 10 weeks


Locations(1)

KK Women's and Children's Hospital

Singapore, Singapore

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NCT07828496


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