AttentionNCT05576649
Dynamic Difficulty Adjustment in a P300 Speller Task for Attention Training
A study testing Task difficulty adaptation according to Arvaneh et al. (2019) and Random task difficulty in people with Attention, run by National University of Ireland, Maynooth at 1 site in Ireland.
Trial summary
This study compares different adaptation approaches in a P300-based BCI neurofeedback training to improve short-term attention. Participants will spell several words on a computer by focusing on a letter on the screen while their brain activity is recorded (P300 speller). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Attention
- What is being tested?
- Task difficulty adaptation according to Arvaneh et al. (2019) and Random task difficulty
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteIreland
- Study dates
- 3 Oct 2022to 13 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
- able to consent
- normal or corrected-to-normal vision
Who cannot join
- history of neurological or cognitive illnesses
- negative reaction to electroconductive gel used in the study (an allergy patch test will be carried out before the experiment starts)
- illiteracy
Trial locations and contacts
1 site in 1 country.
About this study
This study compares different adaptation approaches in a P300-based BCI neurofeedback training to improve short-term attention. Participants will spell several words on a computer by focusing on a letter on the screen while their brain activity is recorded (P300 speller). The difficulty of this task will be adapted to train their attention. Their cognitive abilities will be evaluated using a random dot kinematogram, where they are asked to indicate the direction a fraction of moving dots on the computer screen is going in, before and after the training to analyse any improvements. Questionnaires will be used to compare the perceived task load of the different adaptation approaches.
Read the detailed description
Healthy participants will complete several runs in a P300-speller task, where the number of flashes per row and column is progressively adapted to their performance (in control group 1 and experimental group) or chosen randomly (in control group 2). Decreasing the number of flashes per row and column makes it harder for the computer to identify the letter the participant is focusing on, which encourages them to improve their focus to maintain their performance. The number of flashes can therefore be interpreted as the task difficulty of the P300 speller task.
The participants will complete a continuous version of the random dot kinematogram, where a fraction of incoherently moving dots will start moving coherently. The participants are asked to indicate which direction these dots are moving in. This task is completed before and after the P300 speller training, so that response times in the task can be compared.
To evaluate the perceived task load of the different adaptation approaches, the participants will complete a questionnaire about fatigue and boredom before and after the training session, as well as the NASA Task Load Index at the end of the experiment.
- Conditions
- Attention
- Being tested
- Task difficulty adaptation according to Arvaneh et al. (2019), Random task difficulty, Task difficulty adaptation according to iterative learning controller
- Keywords
- Neurofeedback, Cognitive Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task difficulty adaptation according to Arvaneh et al. (2019)Other
The task difficulty in the P300 speller training will be adapted according to Arvaneh et al. (2019).
Random task difficultyOther
The task difficulty in the P300 speller training is chosen randomly.
Task difficulty adaptation according to iterative learning controllerOther
The task difficulty in the P300 speller is determined by an iterative learning controller.
| Study group | Role | What they receive |
|---|---|---|
| Control Group 1 | Active comparator | In this group, the number of flashes per row and column during the P300 speller training will be adapted based on the participants' previous performance according to the approach used by Arvaneh et al. (2019). Receives: Other: Task difficulty adaptation according to Arvaneh et al. (2019) |
| Control Group 2 | Sham comparator | In this group, the number of flashes per row and column during the P300 speller training will be chosen randomly. It is independent of the participants' performance. Receives: Other: Random task difficulty |
| Experimental Group | Experimental | In this group, the number of flashes per row and column during the P300 speller training will be adapted according to an iterative learning control law that was developed by the principal investigator of this study. The control law uses the previous number of flashes, as well as the participants' previous performance. Receives: Other: Task difficulty adaptation according to iterative learning controller |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in response times in the random dot motion task
The change in mean response times for correct responses in the random dot motion task from pre- to post-training is analysed.
Measured: Measured immediately before and after the training block in the experimental session (~1 hour and 30 minutes total)
Change in accuracy in the random dot motion task
The change in mean accuracy, i.e. number of correct responses over total number of targets, in the random dot motion task from pre- to post-training is analysed.
Measured: Measured immediately before and after the training block in the experimental session (~1 hour and 30 minutes total)
Change in total power of EEG signals
The change in mean total power of EEG signals between 150ms to 550ms post-stimulus for target and non-target trials in the P300 speller task is analysed.
Measured: Measured over the course of the training block in the experimental session (~1 hour and 30 minutes total)
Change in alpha power of EEG signals
The change in mean power of the alpha rhythm in the first 150ms after a non-target stimulus in the P300 speller task is analysed.
Measured: Measured over the course of the training block in the experimental session (~1 hour and 30 minutes total)
Length of training
The length of the P300 training phase is compared between groups.
Measured: Measured over the course of the training block in the experimental session (~1 hour and 30 minutes total)
Secondary outcomes (3)
Change in spelling accuracy in P300 speller task
The change in mean spelling accuracy, i.e. correctly identified letters over all letters in a run, from pre-training to post-training P300 speller runs is analysed.
Measured: Measured immediately before and after the training block in the experimental session (~1 hour and 30 minutes total)
Change in responses to questionnaire
The change in responses to the questionnaire about boredom and fatigue pre- and post-training is analysed. Participants answer the following 4 questions on a 10 point likert scale:(1) How tired are you now?, (2) How alert do you feel?, (3) How bored do you feel?, (4) Do your eyes feel tired? The higher the change in score of the responses, the more tiresome and/or boring the training session was for the participant.
Measured: Measured immediately before and after the training block in the experimental session (~1 hour and 30 minutes total)
Response to NASA Task Load Index questionnaire
The response to the NASA Task Load Index questionnaire post-training is analysed. Participants evaluate mental, physical and temporal demand of the task, as well as their performance, effort and frustration regarding the task on a 21-point scale. A higher score means a higher perceived workload of the training.
Measured: Measured immediately after the training block in the experimental session (~1 hour and 30 minutes total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start3 Oct 2022
- Primary completion13 Mar 2023
- Study completion13 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AttentionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Maynooth
- Sponsor type
- University, hospital or other
- Collaborators
- Dublin City University, Irish Research Council
- Responsible party
- Principal investigator, Sandra-Carina Noble, National University of Ireland, Maynooth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576649
- Sponsor's protocol ID
- BSRESC-2022-2474456
- Status last verified
- Mar 2023
- First submitted
- 28 Sep 2022
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arvaneh M, Robertson IH, Ward TE. A P300-Based Brain-Computer Interface for Improving Attention. Front Hum Neurosci. 2019 Jan 4;12:524. doi: 10.3389/fnhum.2018.00524. eCollection 2018.
PubMed 30662400Noble SC, Woods E, Ward T, Ringwood JV. Adaptive P300-Based Brain-Computer Interface for Attention Training: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Jul 5;12:e46135. doi: 10.2196/46135.
PubMed 37405822
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Difficulty Adjustment in a P300 Speller Task for Attention Training
- ClinicalTrials.gov ID
- NCT05576649
- Acronym / sponsor ID
- BSRESC-2022-2474456
- Conditions
- Attention
- Keywords
- Neurofeedback, Cognitive Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National University of Ireland, MaynoothUniversity, hospital or other
- Collaborators
- Dublin City University, Irish Research Council
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 13 Mar 2023 (actual)
- Study completion
- 13 Mar 2023 (actual)
- First posted
- 12 Oct 2022 (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 study compares different adaptation approaches in a P300-based BCI neurofeedback training to improve short-term attention. Participants will spell several words on a computer by focusing on a letter on the screen while their brain activity is recorded (P300 speller). The difficulty of this task will be adapted to train their attention. Their cognitive abilities will be evaluated using a random dot kinematogram, where they are asked to indicate the direction a fraction of moving dots on the computer screen is going in, before and after the training to analyse any improvements. Questionnaires will be used to compare the perceived task load of the different adaptation approaches.
Detailed description
Healthy participants will complete several runs in a P300-speller task, where the number of flashes per row and column is progressively adapted to their performance (in control group 1 and experimental group) or chosen randomly (in control group 2). Decreasing the number of flashes per row and column makes it harder for the computer to identify the letter the participant is focusing on, which encourages them to improve their focus to maintain their performance. The number of flashes can therefore be interpreted as the task difficulty of the P300 speller task.
The participants will complete a continuous version of the random dot kinematogram, where a fraction of incoherently moving dots will start moving coherently. The participants are asked to indicate which direction these dots are moving in. This task is completed before and after the P300 speller training, so that response times in the task can be compared.
To evaluate the perceived task load of the different adaptation approaches, the participants will complete a questionnaire about fatigue and boredom before and after the training session, as well as the NASA Task Load Index at the end of the experiment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group 1 | Active comparator | Other: Task difficulty adaptation according to Arvaneh et al. (2019)In this group, the number of flashes per row and column during the P300 speller training will be adapted based on the participants' previous performance according to the approach used by Arvaneh et al. (2019). |
| Control Group 2 | Sham comparator | Other: Random task difficultyIn this group, the number of flashes per row and column during the P300 speller training will be chosen randomly. It is independent of the participants' performance. |
| Experimental Group | Experimental | Other: Task difficulty adaptation according to iterative learning controllerIn this group, the number of flashes per row and column during the P300 speller training will be adapted according to an iterative learning control law that was developed by the principal investigator of this study. The control law uses the previous number of flashes, as well as the participants' previous performance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older
- able to consent
- normal or corrected-to-normal vision
Key exclusion criteria (3 listed)
- history of neurological or cognitive illnesses
- negative reaction to electroconductive gel used in the study (an allergy patch test will be carried out before the experiment starts)
- illiteracy
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 |
|---|---|---|
| Task difficulty adaptation according to Arvaneh et al. (2019)The task difficulty in the P300 speller training will be adapted according to Arvaneh et al. (2019). | Other | Control Group 1 |
| Random task difficultyThe task difficulty in the P300 speller training is chosen randomly. | Other | Control Group 2 |
| Task difficulty adaptation according to iterative learning controllerThe task difficulty in the P300 speller is determined by an iterative learning controller. | Other | Experimental Group |
Primary outcome
Change in response times in the random dot motion task
Time frame: Measured immediately before and after the training block in the experimental session (~1 hour and 30 minutes total)
The change in mean response times for correct responses in the random dot motion task from pre- to post-training is analysed.
Change in accuracy in the random dot motion task
Time frame: Measured immediately before and after the training block in the experimental session (~1 hour and 30 minutes total)
The change in mean accuracy, i.e. number of correct responses over total number of targets, in the random dot motion task from pre- to post-training is analysed.
Change in total power of EEG signals
Time frame: Measured over the course of the training block in the experimental session (~1 hour and 30 minutes total)
The change in mean total power of EEG signals between 150ms to 550ms post-stimulus for target and non-target trials in the P300 speller task is analysed.
Change in alpha power of EEG signals
Time frame: Measured over the course of the training block in the experimental session (~1 hour and 30 minutes total)
The change in mean power of the alpha rhythm in the first 150ms after a non-target stimulus in the P300 speller task is analysed.
Length of training
Time frame: Measured over the course of the training block in the experimental session (~1 hour and 30 minutes total)
The length of the P300 training phase is compared between groups.
3 secondary outcomes
Change in spelling accuracy in P300 speller task
Time frame: Measured immediately before and after the training block in the experimental session (~1 hour and 30 minutes total)
Change in responses to questionnaire
Time frame: Measured immediately before and after the training block in the experimental session (~1 hour and 30 minutes total)
Response to NASA Task Load Index questionnaire
Time frame: Measured immediately after the training block in the experimental session (~1 hour and 30 minutes total)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Background: PubMed 30662400Arvaneh M, Robertson IH, Ward TE. A P300-Based Brain-Computer Interface for Improving Attention. Front Hum Neurosci. 2019 Jan 4;12:524. doi: 10.3389/fnhum.2018.00524. eCollection 2018.
- Derived from this study: PubMed 37405822Noble SC, Woods E, Ward T, Ringwood JV. Adaptive P300-Based Brain-Computer Interface for Attention Training: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Jul 5;12:e46135. doi: 10.2196/46135.
- Individual participant dataSharing planned: No
Related trials for Attention
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Not yet recruiting
Development and Evaluation of a Digital Game Intervention Targeting Children Vulnerable to ADHD
ADHD or ADHD Traits
RecruitingObservational study
Multimodal Biomarkers Predicting Medication-Induced Adverse Effects in Children With ADHD
ADHD
Recruiting
Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure
Fetal Alcohol Spectrum Disorders, Attention Deficit Hyperactivity Disorder
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task difficulty adaptation according to Arvaneh et al. (2019) and Random task difficulty in people with Attention, run by National University of Ireland, Maynooth at 1 site in Ireland.
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 3 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: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in response times in the random dot motion task (time frame: Measured immediately before and after the training block in the experimental session (~1 hour and 30 minutes total)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05576649, which also lists 2 linked publications.
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 22 Mar 2023; AzTrials last refreshed its copy on 29 Oct 2026.