NCT07828496 Cognitive Rehabilitation Using Neurofeedback With Brain-computer Interface
| NCT ID | NCT07828496 |
| Status | Recruiting |
| Phase | — |
| Sponsor | KK Women's and Children's Hospital |
| Condition | Acquired Brain Injury Including Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-11-01 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07828496 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 21 Years, studying Acquired Brain Injury Including Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07828496 currently recruiting?
Yes, NCT07828496 is actively recruiting participants. Contact the research team at teo.jia.hui@singhealth.com.sg for enrollment information.
Where is the NCT07828496 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT07828496 clinical trial?
NCT07828496 is sponsored by KK Women's and Children's Hospital. The trial plans to enroll 70 participants.
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