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临床试验/NCT07333339
NCT07333339已完成不适用

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

Uludag University1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2025年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
174
试验地点
1
主要终点
Conners Continuous Performance Test-Third Edition (CPT-3)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Brain-Computer Interface-Based Attention Training (Device)

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.

干预措施: Brain-Computer Interface-Based Attention Training (Device)

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.

干预措施: Brain-Computer Interface-Based Attention Training (Device)

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.

干预措施: Brain-Computer Interface-Based Attention Training (Device)

结局指标

主要结局

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

时间窗: 8 weeks

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.

次要结局

  • 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)

研究者

发起方
Uludag University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Serkan Turan

Assoc Prof.

Uludag University

研究点 (1)

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