NCT05576649

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

October 3, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

September 28, 2022

Last Update Submit

March 21, 2023

Conditions

Keywords

NeurofeedbackCognitive Training

Outcome Measures

Primary Outcomes (5)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (3)

  • Change in spelling accuracy in P300 speller task

    Measured immediately before and after the training block in the experimental session (~1 hour and 30 minutes total)

  • Change in responses to questionnaire

    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

    Measured immediately after the training block in the experimental session (~1 hour and 30 minutes total)

Study Arms (3)

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).

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.

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.

Other: Task difficulty adaptation according to iterative learning controller

Interventions

The task difficulty in the P300 speller training will be adapted according to Arvaneh et al. (2019).

Control Group 1

The task difficulty in the P300 speller training is chosen randomly.

Control Group 2

The task difficulty in the P300 speller is determined by an iterative learning controller.

Experimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • able to consent
  • normal or corrected-to-normal vision

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maynooth University

Maynooth, Co. Kildare, Ireland

Location

Related Publications (2)

  • 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.

    PMID: 30662400BACKGROUND
  • Noble 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 12, 2022

Study Start

October 3, 2022

Primary Completion

March 13, 2023

Study Completion

March 13, 2023

Last Updated

March 22, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations