An interventional study of Brain-computer interface with neurofeedback with 3D game sessions in Acquired Brain Injury Including Stroke and Epilepsy, sponsored by KK Women's and Children's Hospital. Recruiting at 1 site in Singapore. Open to participants aged 7 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by KK Women's and Children's Hospital · Not applicable, Interventional, and Supportive care
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:
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:
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.
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
This study's planned enrollment of 70 is above the median of 50 across 1,239 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →KK Women's and Children's Hospital is the lead sponsor of 137 studies on the registry; 33 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Normaitve cohort:
- Patients with no history of epilepsy
Inclusion Criteria:
Exclusion Criteria:
Intervention then standard of care
Other: Brain-computer interface with neurofeedback with 3D game sessions
Usual care followed by intervention
Other: Brain-computer interface with neurofeedback with 3D game sessions
12 sessions of BCI-NFT computer games over 10 weeks
Also known as: BCI-NFT
Change in Attention Threshold
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.
Time frame: Baseline (Session 1) to final session (Session 12), over 10 weeks
Change in Relaxation Threshold
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.
Time frame: Baseline (Session 1) to final session (Session 12), over 10 weeks
Change in Response Time
Change in mean response time to in-game stimuli, measured in milliseconds, at each session.
Time frame: Baseline (Session 1) to final session (Session 12), over 10 weeks
Change in Alpha-Lateralization Index
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.
Time frame: Baseline (Session 1) to final session (Session 12), over 10 weeks
Change in Beta-to-Alpha Power Ratio
Change in the ratio of EEG beta-band to alpha-band spectral power, a unitless ratio, measured at each session.
Time frame: Baseline (Session 1) to final session (Session 12), over 10 weeks
Internalising problem score on Behavior Assessment System for Children, Third Edition (BASC-3)
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.
Time frame: From enrollment to 20 weeks
Externalising symptoms score in Behavior Assessment System for Children, Third Edition (BASC-3)
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
Time frame: From enrollment to end of study 20 weeks
Plan to share: No — Consent for sharing of individual patient data was not obtained from participants
Started Nov 2025 (actual). Primary completion is estimated for Feb 2028, 27 months after the start.
Of 337 non-industry interventional studies with no phase under Epilepsy, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 77. This study's planned 27 months is below that.
Counting every sponsor, half of 358 studies reached it within 42 months; a quarter within 19 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
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