Adaptive P300-Based Brain-Computer Interface for Attention Training: Protocol for a Randomized Controlled Trial.

Background: The number of people with cognitive deficits and diseases, such as stroke, dementia, or attention-deficit/hyperactivity disorder, is rising due to an aging, or in the case of attention-deficit/hyperactivity disorder, a growing population. Neurofeedback training using brain-computer interfaces is emerging as a means of easy-to-use and noninvasive cognitive training and rehabilitation. A novel application of neurofeedback training using a P300-based brain-computer interface has previously shown potential to improve attention in healthy adults.

Objective: This study aims to accelerate attention training using iterative learning control to optimize the task difficulty in an adaptive P300 speller task. Furthermore, we hope to replicate the results of a previous study using a P300 speller for attention training, as a benchmark comparison. In addition, the effectiveness of personalizing the task difficulty during training will be compared to a nonpersonalized task difficulty adaptation.

Methods: In this single-blind, parallel, 3-arm randomized controlled trial, 45 healthy adults will be recruited and randomly assigned to the experimental group or 1 of 2 control groups. This study involves a single training session, where participants receive neurofeedback training through a P300 speller task. During this training, the task's difficulty is progressively increased, which makes it more difficult for the participants to maintain their performance. This encourages the participants to improve their focus. Task difficulty is either adapted based on the participants' performance (in the experimental group and control group 1) or chosen randomly (in control group 2). Changes in brain patterns before and after training will be analyzed to study the effectiveness of the different approaches. Participants will complete a random dot motion task before and after the training so that any transfer effects of the training to other cognitive tasks can be evaluated. Questionnaires will be used to estimate the participants' fatigue and compare the perceived workload of the training between groups.

Results: This study has been approved by the Maynooth University Ethics Committee (BSRESC-2022-2474456) and is registered on ClinicalTrials.gov (NCT05576649). Participant recruitment and data collection began in October 2022, and we expect to publish the results in 2023.

Conclusions: This study aims to accelerate attention training using iterative learning control in an adaptive P300 speller task, making it a more attractive training option for individuals with cognitive deficits due to its ease of use and speed. The successful replication of the results from the previous study, which used a P300 speller for attention training, would provide further evidence to support the effectiveness of this training tool.

Trial Registration: ClinicalTrials.gov NCT05576649; https://clinicaltrials.gov/ct2/show/NCT05576649.

International Registered Report Identifier (irrid): DERR1-10.2196/46135.