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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05576649
Other study ID # BSRESC-2022-2474456
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 3, 2022
Est. completion date March 13, 2023

Study information

Verified date March 2023
Source National University of Ireland, Maynooth
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date March 13, 2023
Est. primary completion date March 13, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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).
Random task difficulty
The task difficulty in the P300 speller training is chosen randomly.
Task difficulty adaptation according to iterative learning controller
The task difficulty in the P300 speller is determined by an iterative learning controller.

Locations

Country Name City State
Ireland Maynooth University Maynooth Co. Kildare

Sponsors (3)

Lead Sponsor Collaborator
National University of Ireland, Maynooth Dublin City University, Irish Research Council

Country where clinical trial is conducted

Ireland, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 immediately before and after the training block in the experimental session (~1 hour and 30 minutes total)
Primary 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 immediately before and after the training block in the experimental session (~1 hour and 30 minutes total)
Primary 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 over the course of the training block in the experimental session (~1 hour and 30 minutes total)
Primary 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 over the course of the training block in the experimental session (~1 hour and 30 minutes total)
Primary Length of training The length of the P300 training phase is compared between groups. Measured over the course of the training block in the experimental session (~1 hour and 30 minutes total)
Secondary 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 immediately before and after the training block in the experimental session (~1 hour and 30 minutes total)
Secondary 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 immediately before and after the training block in the experimental session (~1 hour and 30 minutes total)
Secondary 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 immediately after the training block in the experimental session (~1 hour and 30 minutes total)
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