Cognitive Rehabilitation Using Neurofeedback With Brain-computer Interface

NCT07828496 | Recruiting DMC

• 1 other identifier: 2024/2114
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Epilepsy; Acquired Brain Injury Including Stroke

Outcome Measures

Primary Outcomes (5)

• 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.

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

• 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.

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

• Change in Response Time

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

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

• 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.

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

• Change in Beta-to-Alpha Power Ratio

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

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

Secondary Outcomes (2)

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

  From enrollment to 20 weeks

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

  From enrollment to end of study 20 weeks

Study Arms (2)

BCI

EXPERIMENTAL

Intervention then standard of care

Other: Brain-computer interface with neurofeedback with 3D game sessions

Usual care

EXPERIMENTAL

Usual care followed by intervention

Other: Brain-computer interface with neurofeedback with 3D game sessions

Interventions

Brain-computer interface with neurofeedback with 3D game sessions OTHER

12 sessions of BCI-NFT computer games over 10 weeks

Also known as: BCI-NFT

BCI; Usual care

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Post acquired brain injury (stroke, encephalitis, brain tumour, traumatic brain injury)
• Epilepsy

You may not qualify if:

• 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

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

Brain-Computer Interfaces; Neurofeedback

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies; Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Central Study Contacts

Jia Hui Teo

CONTACT

+6563926042; teo.jia.hui@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 18, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)