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

NCT ID: NCT07333339

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 174 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-11-10

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

COGO + Methylphenidate

Children in this cohort receive a combined intervention consisting of a brain-computer interface (BCI)-based attention training program (COGO) together with methylphenidate prescribed as part of routine clinical care. The attention training is delivered through game-based computerized sessions that adapt to the child's attention-related brain signals. Methylphenidate dosing follows standard clinical practice and is determined by the treating clinician.

Brain-Computer Interface-Based Attention Training

Intervention Type: DEVICE

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

COGO + Citicoline

Children in this cohort receive the same BCI-based attention training program (COGO) combined with citicoline supplementation. Citicoline is administered in age-appropriate doses as part of usual clinical care. The BCI training consists of structured, game-based sessions designed to support sustained attention and cognitive control.

Brain-Computer Interface-Based Attention Training

Intervention Type: DEVICE

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

COGO Only

Children in this cohort participate only in the BCI-based attention training program (COGO), without concurrent stimulant medication or citicoline supplementation. The training is delivered through computerized, game-based sessions that adjust task demands based on real-time attention-related brain signals.

Brain-Computer Interface-Based Attention Training

Intervention Type: DEVICE

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

Citicoline Only

Children in this cohort receive citicoline supplementation alone, without participation in the BCI-based attention training program. Citicoline is administered in age-appropriate doses as part of routine clinical management for attention-related difficulties.

Brain-Computer Interface-Based Attention Training

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

School-age children (approximately 6-18 years)

Clinical diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)

Presence of attention or executive-function difficulties requiring clinical follow-up

Participation in one of the routine clinical interventions (BCI-based attention training, methylphenidate, citicoline, or their combination)

Completion of baseline and post-intervention assessments

Written informed consent obtained from a parent or legal guardian

Exclusion Criteria

Presence of a neurological disorder (e.g., epilepsy, traumatic brain injury)

Intellectual disability or severe developmental disorder that would prevent participation in computerized assessments

Current use of additional psychotropic medications other than methylphenidate

Significant sensory or motor impairment interfering with computer-based testing

Incomplete assessment data or inability to complete the intervention period

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uludag University

OTHER

Sponsor Role: lead

Responsible Party

Serkan Turan

Assoc Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Serkan Turan

Role: PRINCIPAL_INVESTIGATOR

Uludag University

Locations

Uludag University

Bursa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

1. da Silva, B. S., Grevet, E. H., Silva, L. C. F., Ramos, J. K. N., Rovaris, D. L., & Bau, C. H. D. (2023). An overview on neurobiology and therapeutics of attention-deficit/hyperactivity disorder. Discover mental health, 3(1), 2. https://doi.org/10.1007/s44192-022-00030-1 2. Hwang, S., Meffert, H., Parsley, I., Tyler, P. M., Erway, A. K., Botkin, M. L., Pope, K., & Blair, R. J. R. (2019). Segregating sustained attention from response inhibition in ADHD: An fMRI study. NeuroImage. Clinical, 21, 101677. https://doi.org/10.1016/j.nicl.2019.101677 3. Noah, A.A., Sedky, H.E. New frontiers in pharmacological treatment of attention-deficit hyperactivity disorder. Naunyn-Schmiedeberg's Arch Pharmacol 398, 15025-15035 (2025). https://doi.org/10.1007/s00210-025-04328-z 4. Levy, F., Pipingas, A., Harris, E. V., Farrow, M., & Silberstein, R. B. (2018). Continuous performance task in ADHD: Is reaction time variability a key measure?. Neuropsychiatric disease and treatment, 14, 781-786. https://doi.org/10.2147/NDT.S158308 5. Kansakar, U., Trimarco, V., Mone, P., Varzideh, F., Lombardi, A., & Santulli, G. (2023). Choline supplements: An update. Frontiers in endocrinology, 14, 1148166. https://doi.org/10.3389/fendo.2023.1148166 6. Hübner, I. B., Scheibe, D. B., Marchezan, J., & Bücker, J. (2024). Use of Citicoline in Attention-Deficit/Hyperactivity Disorder: A Pilot Study. Clinical neuropharmacology, 47(5), 146-149. https://doi.org/10.1097/WNF.0000000000000602 7. Ölçüoğlu R. (2025). Neurofeedback for ADHD: Exploring the Role of Quantitative EEG and Brainwave Modulation. Brain and behavior, 15(8), e70714. https://doi.org/10.1002/brb3.70714 8. Jeunet, C., Glize, B., McGonigal, A., Batail, J. M., & Micoulaud-Franchi, J. A. (2019). Using EEG-based brain computer interface and neurofeedback targeting sensorimotor rhythms to improve motor skills: Theoretical background, applications and prospects. Neurophysiologie clinique = Clinical neurophysiology, 49(2), 125-136. https://doi.org/10.

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

THIZ-2023-1670

Identifier Type: -

Identifier Source: org_study_id