跳至主要内容
临床试验/NCT07109830
NCT07109830招募中不适用

Utilizing an Electroencephalography-Based Brain-Computer Interface Game to Evaluate Cognitive Skills in Children With Motor Impairments

University of Alberta3 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2025年11月11日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
73
试验地点
3
主要终点
Neuropsychological assessment (NEPSY-II)

研究概览

简要总结

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. Pilot Study: Tests the feasibility of the BCI game, comparing BCI and keyboard controls, and examines alignment with NEPSY-II cognitive subtests.
  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. Adaptation Study: Compares game performance between neurotypical children and children with motor impairments to evaluate the game's inclusivity and adaptability.

The project utilizes the Emotiv Flex 2 EEG system and focuses on cognitive domains such as attention, working memory, and inhibition. The ultimate goal is to develop a reliable, equitable tool for assessing cognition in children with diverse motor abilities.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
7 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with and without motor impairments.
  • Understand simple commands

排除标准

  • Vision impairment

结局指标

主要结局

Neuropsychological assessment (NEPSY-II)

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

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.

BCI game metrics

时间窗: Baseline (Day 1; during the single study visit)

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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