NCT07333339

A Brain-Computer Interface-Based Attention Training Program Compared With Methylphenidate and Citicoline

Comparative Effects of BCI-Based Attention Training, Methylphenidate, and Citicoline on Attention and Executive Function in School-Age Children: A Naturalistic Quasi-Experimental Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 174 (actual)
• Sponsor: Uludag University · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to learn whether a brain-computer interface (BCI)-based attention training program, used alone or together with medication, can improve attention, executive functioning, and emotional regulation in school-age children with attention difficulties. The study focuses on school-age children who were referred for problems with attention, concentration, or related cognitive and emotional difficulties. The main questions it aims to answer are: Does BCI-based attention training improve children's attention and response control when used on its own? Do children show greater improvements when BCI-based attention training is combined with medication such as methylphenidate or citicoline? Are there differences in attention, executive functioning, or emotional symptoms between children receiving combined approaches versus single treatments? Researchers compared four naturally occurring treatment approaches to see whether combining attention training with medication leads to better outcomes than using one method alone. Participants will: Take part in a computerized, game-based BCI attention training program that uses brain signals to guide training tasks Receive medication (methylphenidate or citicoline) if this was part of their usual clinical care Complete computerized attention tests that measure focus, reaction time, and impulse control Have parents complete questionnaires about attention, behavior, emotions, and everyday executive functioning before and after the intervention This study was conducted in a real-world clinical setting and reflects routine treatment choices made by families and clinicians, rather than random assignment. The findings aim to help families and health care providers better understand how different treatment combinations may support attention and self-regulation in children.

Detailed description

Attention difficulties in childhood, including problems with sustained focus, impulse control, and executive functioning, are common reasons for referral to child and adolescent mental health services. While stimulant medications such as methylphenidate are widely used and effective for many children, not all families prefer medication alone, and some children continue to experience cognitive or emotional difficulties despite treatment. For these reasons, there is growing interest in non-pharmacological and combined approaches that target attention through different mechanisms. One emerging approach is brain-computer interface (BCI)-based attention training. These programs use real-time brain signals, recorded through EEG sensors, to adapt game-like tasks that encourage sustained attention and cognitive control. Unlike traditional computer games, task difficulty and progression change dynamically based on the child's level of attentional engagement. This makes training more interactive and potentially more closely linked to underlying brain processes involved in attention regulation. In routine clinical practice, some children receive BCI-based attention training alone, while others use it together with medication such as methylphenidate or citicoline. Citicoline is a nutritional supplement that has been suggested to support brain function and cognitive processes, although evidence in children remains limited. How these different approaches compare with one another, and whether combining them offers added benefit, is still not well understood. This study was conducted in a naturalistic clinical setting, meaning that treatment choices were made as part of usual care rather than through random assignment. Children were grouped based on the intervention they received: BCI-based attention training alone, BCI combined with methylphenidate, BCI combined with citicoline, or citicoline alone. All children completed standardized assessments before and after the intervention period. Attention and cognitive performance were evaluated using a computerized continuous performance test that measures sustained attention, reaction time, variability of responses, and impulse control. In addition, parents completed validated questionnaires assessing attention-related symptoms, emotional difficulties, and everyday executive functioning such as planning, inhibition, and emotional regulation. By examining changes within each treatment group and comparing overall patterns across groups, this study aims to provide clinically meaningful information about how different treatment strategies may support attention and self-regulation in children. The findings are intended to help families and health care providers make more informed decisions about combining digital attention training with medication in real-world clinical settings.

Conditions

• Attention Deficit Hyperactivity Disorder (ADHD)
• Brain Computer Interface

Interventions

Type	Name	Description
DEVICE	Brain-Computer Interface-Based Attention Training	The intervention consists of a brain-computer interface (BCI)-based attention training program delivered through computerized, game-based tasks that adapt in real time to the participant's attention-related brain activity recorded via EEG. Task difficulty and progression are dynamically adjusted based on neural markers of attentional engagement, creating a closed-loop training environment designed to support sustained attention, response control, and executive functioning. In some participants, this training is used in combination with pharmacological or nutraceutical support as part of routine clinical care. Methylphenidate is prescribed according to standard pediatric clinical guidelines and individualized clinical judgment. Citicoline is administered in age-appropriate doses as a nutritional supplement intended to support cognitive and neural functioning. No experimental dosing or protocol-driven medication adjustments are applied. All interventions are delivered in a naturalistic

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-11-01
• Completion: 2025-11-10
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

1 site across 1 country: Turkey (Türkiye)