- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05576649
Dynamic Difficulty Adjustment in a P300 Speller Task for Attention Training
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Co. Kildare
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Maynooth, Co. Kildare, Ireland
- Maynooth University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years and older
- able to consent
- normal or corrected-to-normal vision
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Control Group 1
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).
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The task difficulty in the P300 speller training will be adapted according to Arvaneh et al. (2019).
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Sham Comparator: Control Group 2
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.
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The task difficulty in the P300 speller training is chosen randomly.
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Experimental: Experimental Group
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.
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The task difficulty in the P300 speller is determined by an iterative learning controller.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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The change in mean response times for correct responses in the random dot motion task from pre- to post-training is analysed.
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Measured immediately before and after the training block in the experimental session (~1 hour and 30 minutes total)
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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)
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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.
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Measured immediately before and after the training block in the experimental session (~1 hour and 30 minutes total)
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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)
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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.
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Measured over the course of the training block in the experimental session (~1 hour and 30 minutes total)
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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)
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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.
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Measured over the course of the training block in the experimental session (~1 hour and 30 minutes total)
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Length of training
Time Frame: Measured over the course of the training block in the experimental session (~1 hour and 30 minutes total)
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The length of the P300 training phase is compared between groups.
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Measured over the course of the training block in the experimental session (~1 hour and 30 minutes total)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
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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.
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Measured immediately before and after the training block in the experimental session (~1 hour and 30 minutes total)
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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)
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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.
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Measured immediately before and after the training block in the experimental session (~1 hour and 30 minutes total)
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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)
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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.
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Measured immediately after the training block in the experimental session (~1 hour and 30 minutes total)
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BSRESC-2022-2474456
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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