Acquired Brain Injury Including StrokeNCT07828496
Cognitive Rehabilitation Using Neurofeedback With Brain-computer Interface
A study testing Brain-computer interface with neurofeedback with 3D game sessions in people with Acquired Brain Injury Including Stroke and Epilepsy, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Acquired Brain Injury Including Stroke, Epilepsy
- What is being tested?
- Brain-computer interface with neurofeedback with 3D game sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Nov 2025to 30 Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Post acquired brain injury (stroke, encephalitis, brain tumour, traumatic brain injury)
- Epilepsy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
KK Women's and Children's Hospital
Singapore
Jia Hui Teo, MBBS, +6563926042, teo.jia.hui@singhealth.com.sg
Nabil, 6563947254
About this study
Official title: 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.
Read more
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.
- Conditions
- Acquired Brain Injury Including Stroke, Epilepsy
- Being tested
- Brain-computer interface with neurofeedback with 3D game sessions
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain-computer interface with neurofeedback with 3D game sessionsOther
Also called BCI-NFT
12 sessions of BCI-NFT computer games over 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| BCI | Experimental | Intervention then standard of care Receives: Other: Brain-computer interface with neurofeedback with 3D game sessions |
| Usual care | Experimental | Usual care followed by intervention Receives: Other: Brain-computer interface with neurofeedback with 3D game sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Session 1) to final session (Session 12), over 10 weeks
Secondary outcomes (2)
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.
Measured: 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
Measured: From enrollment to end of study 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Nov 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain Injury Including StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Teo Jia Hui, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828496
- Sponsor's protocol ID
- 2024/2114
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Consent for sharing of individual patient data was not obtained from participants