Cognitive Rehabilitation Using Neurofeedback With Brain-computer Interface

Condition(s) studied

Investigational drug(s) / intervention(s)

Brain-computer interface with neurofeedback with 3D game sessions: 12 sessions of BCI-NFT computer games over 10 weeks

Study 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

Primary outcome measure(s)

• Change in Attention Threshold — 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.
• Change in Relaxation Threshold — 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.
• Change in Response Time — 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.
• Change in Alpha-Lateralization Index — 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.
• Change in Beta-to-Alpha Power Ratio — 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.

Trial sites (1)

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