Children With Motor ImpairmentsNCT07109830
Utilizing an EEG-Based BCI Game to Evaluate Cognitive Skills in Children With Motor Impairments
An observational study of Children With Motor Impairments, run by University of Alberta at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Children With Motor Impairments
- What is being tested?
- Cognitive assessment and NEPSY-II
- How many people
- 73 participants
- Where
- 2 sitesCanada
- Study dates
- 11 Nov 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- Child
Study population: Typically developing children and children with motor impairments
Who may be able to join
- Children with and without motor impairments.
- Ages 7-16.
- Understand simple commands
Who cannot join
- Vision impairment
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Not yet recruiting
University of Alberta
Edmonton, Alberta, T6G 2B9
Adriana Rios Rincon, 7802248685, aros@ualberta.ca
- Recruiting
University of Alberta
Edmonton, Alberta
PhD Candidate, 7809204861, malsubai@ualberta.ca
About this study
Official title: Utilizing an Electroencephalography-Based Brain-Computer Interface Game to Evaluate Cognitive Skills in Children With Motor Impairments
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:
Read more
- Pilot Study: Tests the feasibility of the BCI game, comparing BCI and keyboard controls, and examines alignment with NEPSY-II cognitive subtests.
- Validation Study: Investigates the convergent validity of the BCI game in typically developing children by correlating game performance with standardized cognitive test scores.
- 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.
- Conditions
- Children With Motor Impairments
- Being tested
- Cognitive assessment, NEPSY-II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive assessmentDiagnostic test
Cognitive assessment using BCI-game
NEPSY-IIDiagnostic test
Standardized cognitive assessment
| Study group | Role | What they receive |
|---|---|---|
| Typically developing children | Not described Receives: Diagnostic Test: Cognitive assessment; Diagnostic Test: NEPSY-II | |
| Children with motor impairments | Not described Receives: Diagnostic Test: Cognitive assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "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.
Measured: Baseline (Day 1; during the single study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start11 Nov 2025
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Motor ImpairmentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109830
- Sponsor's protocol ID
- Pro00153206
- Status last verified
- Nov 2025
- First submitted
- 21 Jul 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only people working on this project will have access to identifiable information and it will be store in an encrypted file
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing an Electroencephalography-Based Brain-Computer Interface Game to Evaluate Cognitive Skills in Children With Motor Impairments
- ClinicalTrials.gov ID
- NCT07109830
- Acronym / sponsor ID
- Pro00153206
- Conditions
- Children With Motor Impairments
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Pilot Study: Tests the feasibility of the BCI game, comparing BCI and keyboard controls, and examines alignment with NEPSY-II cognitive subtests.
- Validation Study: Investigates the convergent validity of the BCI game in typically developing children by correlating game performance with standardized cognitive test scores.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Typically developing children | – | Diagnostic Test: Cognitive assessment, Diagnostic Test: NEPSY-II |
| Children with motor impairments | – | Diagnostic Test: Cognitive assessment |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- Typically developing children and children with motor impairments
Key inclusion criteria (3 listed)
- Children with and without motor impairments.
- Ages 7-16.
- Understand simple commands
Key exclusion criteria (1 listed)
- Vision impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive assessmentCognitive assessment using BCI-game | Diagnostic test | Children with motor impairments, Typically developing children |
| NEPSY-IIStandardized cognitive assessment | Diagnostic test | Typically developing children |
Primary outcome
Neuropsychological assessment (NEPSY-II)
Time frame: "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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No. Only people working on this project will have access to identifiable information and it will be store in an encrypted file
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children With Motor Impairments, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Munirah Alsubaie (7809204861, malsubai@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological assessment (NEPSY-II) (time frame: "Baseline (Day 1): NEPSY-II will be administered during the single study session at the same visit as the BCI game."). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.