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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 21
Healthy Volunteers: t
View:

• Post acquired brain injury (stroke, encephalitis, brain tumour, traumatic brain injury)

• Epilepsy

Locations
Other Locations
Singapore
KK Women's and Children's Hospital
RECRUITING
Singapore
Contact Information
Primary
Jia Hui Teo
teo.jia.hui@singhealth.com.sg
+6563926042
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 70
Treatments
Experimental: BCI
Intervention then standard of care
Experimental: Usual care
Usual care followed by intervention
Related Therapeutic Areas
Sponsors
Leads: KK Women's and Children's Hospital

This content was sourced from clinicaltrials.gov