Trening poznawczy przy użyciu interfejsu mózg-komputer i neurofeedbacku

ClinicalTrials.gov➕ 19.09.2026Status: Trwa rekrutacjaFaza: Nie dotyczy

Cognitive Rehabilitation Using Neurofeedback With Brain-computer Interface

W skrócie

Badanie sprawdza, czy specjalny trening z interfejsem mózg-komputer (urządzenie odczytujące fale mózgowe) może poprawić funkcje poznawcze, takie jak pamięć i uwaga, u dzieci i młodzieży po urazach mózgu, w tym udarach, zapaleniach opon mózgowych lub epilepsji. Pacjenci uczestniczą w 12 sesjach zabawy komputerowej trwających 10 tygodni, podczas których noszą bezprzewodowy czujnik na głowie rejestrujący aktywność mózgu. Badanie porównuje grupę dzieci otrzymujących ten nowy trening plus standardową rehabilitację z grupą czekającą na leczenie, aby sprawdzić, czy interfejs mózg-komputer naprawdę pomaga.

Oryginalny opis (angielski)

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.

Metadane badania

NCT ID
NCT07828496
Status
Trwa rekrutacja
Faza
Nie dotyczy
Sponsor
KK Women's and Children's Hospital
Data startu
01.11.2025
Choroby
Acquired Brain Injury Including Stroke, Epilepsy
Kraje
Singapore