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

NCT07333339 | Completed

• 1 other identifier: THIZ-2023-1670
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Computer Interface; Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

Brain-computer interface; attention training; methylphenidate; citicoline; cognitive training; executive functions

Outcome Measures

Primary Outcomes (1)

• Conners Continuous Performance Test-Third Edition (CPT-3)

  Outcome Measure 1:Conners Continuous Performance Test-Third Edition CPT-3)-Omission Errors.Number of omission errors reflecting inattention, reported as standardized T-scores based on CPT-3 normative data.Unit of Measure: T-score. Outcome Measure 2:CPT-3-Commission Errors. Number of commission errors reflecting impulsivity (standardized T-scores derived from CPT-3 normative data).Unit of Measure: T-score. Outcome Measure 3:CPT-3-Perseverations.Number of perseverative responses reflecting response control difficulties, reported as standardized T-scores based on CPT-3 normative data.Unit of Measure: T-score. Outcome Measure 4:CPT-3-Hit Reaction Time(HRT).Mean reaction time for correct responses (standardized T-scores derived from CPT-3 normative data).Unit of Measure: T-score. Outcome Measure 5:CPT-3-Hit Reaction Time Standard Deviation(HRT SD).Variability of reaction time across correct responses, reported as standardized T-scores based on CPT-3 normative data.Unit of Measure: T-score.

  8 weeks

Secondary Outcomes (5)

• 1. Swanson, Nolan, and Pelham Rating Scale-Fourth Edition (SNAP-IV)

  8 weeks

• 2. Barkley Sluggish Cognitive Tempo Scale

  8 weeks

• 3. Revised Child Anxiety and Depression Scale (RCADS), Parent Version

  8 weeks

• 4. Strengths and Difficulties Questionnaire (SDQ)

  8 weeks

• 5. Behavior Rating Inventory of Executive Function (BRIEF)

  8 weeks

Study Arms (4)

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.

Device: Brain-Computer Interface-Based Attention Training

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.

Device: Brain-Computer Interface-Based Attention Training

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.

Device: Brain-Computer Interface-Based Attention Training

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.

Device: Brain-Computer Interface-Based Attention Training

Interventions

Brain-Computer Interface-Based Attention Training 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; COGO + Methylphenidate; COGO Only; Citicoline Only

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of school-age children referred to a child and adolescent psychiatry outpatient clinic due to attention-related difficulties. All participants have a clinical diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD) and were receiving routine clinical care at the time of enrollment. The population reflects a real-world clinical sample, including children with varying levels of attentional, executive-function, and emotional difficulties commonly observed in pediatric ADHD. Treatment selection was based on usual clinical decision-making rather than random assignment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Uludag University

Bursa, 16440, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Serkan Turan

  Uludag University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 8 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof.

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 12, 2026
• Study Start: February 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 10, 2025
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)