Cognitive Rehabilitation Using Neurofeedback With Brain-computer Interface
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-21
SponsorKK Women's and Children's Hospital
About this 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.
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 criteria
This trial accepts healthy volunteersQualifiers
Post acquired brain injury (stroke, encephalitis, brain tumour, traumatic brain injury)
Epilepsy
Disqualifiers
History of photosensitive seizures
Diagnosis of intellectual disability
Presence of psychotic symptoms
Diagnosis of attention deficit and hyperactivity disorder
Trial design
Design model
Crossover
Treatments tested in this trial
Brain-computer interface with neurofeedback with 3D game sessions
Other intervention12 sessions of BCI-NFT computer games over 10 weeks
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: BCIExperimental treatment 1 intervention
Group B: Usual careExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSecondary outcomes
1
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 weeks2
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 weeksSponsors and contacts
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Source ClinicalTrials.gov