Utilizing an EEG-Based BCI Game to Evaluate Cognitive Skills in Children With Motor Impairments

NCT07109830 | Recruiting

• 1 other identifier: Pro00153206
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 2

Brief Summary

This project aims to validate an EEG-based brain-computer interface (BCI) game as a cognitive assessment tool for children with motor impairments. Traditional cognitive assessments often rely on motor responses, which may underestimate the abilities of children with limited mobility. By using BCI technology, which captures brain activity directly, the study seeks to bypass these limitations and offer a more inclusive, engaging, and accurate assessment method. The research consists of three papers:

1. 1.Pilot Study: Tests the feasibility of the BCI game, comparing BCI and keyboard controls, and examines alignment with NEPSY-II cognitive subtests.
2. 2.Validation Study: Investigates the convergent validity of the BCI game in typically developing children by correlating game performance with standardized cognitive test scores.
3. 3.Adaptation Study: Compares game performance between neurotypical children and children with motor impairments to evaluate the game's inclusivity and adaptability.

Conditions

Children With Motor Impairments

Outcome Measures

Primary Outcomes (2)

• Neuropsychological assessment (NEPSY-II)

  The NEPSY-II (A Developmental Neuropsychological Assessment, Second Edition) is a standardized cognitive assessment for children aged 3-16 years. It evaluates multiple domains of cognitive functioning, including Attention and Executive Functioning, Memory and Learning, and Visuospatial Processing. Each subtest yields a scaled score ranging from 1 to 19 (mean = 10, SD = 3) and domain-level standard scores (mean = 100, SD = 15). Higher scores indicate better cognitive performance.

  "Baseline (Day 1): NEPSY-II will be administered during the single study session at the same visit as the BCI game."

• BCI game metrics

  The BCI-controlled adventure-style game is designed to assess cognitive domains including attention, working memory, and inhibitory control. Participants navigate a virtual environment by turning left or right using brain-computer interface control based on steady-state visually evoked potentials (SSVEP). Coins collected reflect the participant's sustained attention and working memory by requiring consistent focus and memory of task-specific rules (e.g., avoiding certain coin colors). Obstacles avoided reflect inhibitory control by requiring participants to suppress automatic responses and adapt to changing task demands. Each metric is a count variable (0-maximum possible in the game), where higher values indicate better cognitive performance.

  Baseline (Day 1; during the single study visit)

Study Arms (2)

Typically developing children

Diagnostic Test: Cognitive assessment; Diagnostic Test: NEPSY-II

Children with motor impairments

Diagnostic Test: Cognitive assessment

Interventions

Cognitive assessment DIAGNOSTIC_TEST

Cognitive assessment using BCI-game

Children with motor impairments; Typically developing children

NEPSY-II DIAGNOSTIC_TEST

Standardized cognitive assessment

Typically developing children

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Typically developing children and children with motor impairments

You may qualify if:

• Children with and without motor impairments.
• Ages 7-16.
• Understand simple commands

You may not qualify if:

• Vision impairment

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (2)

University of Alberta

Edmonton, Alberta, T6G 2B9, Canada

NOT YET RECRUITING

University of Alberta

Edmonton, Alberta, Canada

RECRUITING

Central Study Contacts

Munirah Alsubaie

CONTACT

7809204861; malsubai@ualberta.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 7, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)