Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07828496

Cognitive Rehabilitation Using Neurofeedback With Brain-computer Interface

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

7 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain-computer interface with neurofeedback with 3D game sessions

Other

12 sessions of BCI-NFT computer games over 10 weeks

Other names: BCI-NFT

Primary outcomes

  1. Change in Attention Threshold

    Time frame: Baseline (Session 1) to final session (Session 12), over 10 weeks

    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.

  2. Change in Relaxation Threshold

    Time frame: Baseline (Session 1) to final session (Session 12), over 10 weeks

    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.

  3. Change in Response Time

    Time frame: Baseline (Session 1) to final session (Session 12), over 10 weeks

    Change in mean response time to in-game stimuli, measured in milliseconds, at each session.

  4. Change in Alpha-Lateralization Index

    Time frame: Baseline (Session 1) to final session (Session 12), over 10 weeks

    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.

  5. Change in Beta-to-Alpha Power Ratio

    Time frame: Baseline (Session 1) to final session (Session 12), over 10 weeks

    Change in the ratio of EEG beta-band to alpha-band spectral power, a unitless ratio, measured at each session.

Secondary outcomes

  1. Internalising problem score on Behavior Assessment System for Children, Third Edition (BASC-3)

    Time frame: From enrollment to 20 weeks

    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.

  2. Externalising symptoms score in Behavior Assessment System for Children, Third Edition (BASC-3)

    Time frame: From enrollment to end of study 20 weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Jia Hui Teo

CONTACT

[email protected]

+6563926042

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.