Effects of iTBS on Cognitive Control in Children With ADHD: A Randomized, Sham-Controlled Study Integrating EEG During ANT, fNIRS, MRI, and Genetic Markers
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Change in Executive Attention Efficiency as Measured by the Attention Network Test (ANT)
研究概览
简要总结
The goal of this clinical trial is to learn if brain stimulation can help children ages 6 to 12 with attention-deficit/hyperactivity disorder (ADHD) improve their attention and self-control. The main questions it aims to answer are:
Does intermittent theta burst stimulation (iTBS) improve performance on a task that tests attention and reaction times? Can brain activity and genetics help predict who benefits most from this treatment?
Researchers will compare randomly assigned active iTBS to sham (inactive) stimulation groups to see if the treatment helps.
Participants will:
Receive 10 sessions of either active or sham iTBS over 2 weeks Complete a computer task measuring attention before and after stimulation Wear a brain cap during the task to record EEG signals, also take part in resting-state brain scans, namely magnetic resonance imaging (MRI) and functional near-infrared spectroscopy (fNIRS), and provide a saliva sample for genetic testing
详细描述
This study explores whether noninvasive brain stimulation can improve attention control in children diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD), and how biological factors such as brain activity, brain structure, and genetics may predict individual differences in response. The primary focus is on executive attention-the ability to focus on relevant information, ignore distractions, and resolve conflicts between competing signals. These skills are often impaired in children with ADHD and closely linked to underlying differences in brain function.
To address this, the study uses intermittent theta burst stimulation (iTBS), a specialized form of transcranial magnetic stimulation (TMS). This method delivers rapid bursts of magnetic energy in intervals that are designed to increase the excitability of the targeted brain region. The stimulation is applied to the right dorsolateral prefrontal cortex (DLPFC), a key area involved in attention regulation, response inhibition, and cognitive control-functions that are often altered in ADHD.
A total of 40 children between the ages of 6 and 12 will participate. All must have a confirmed diagnosis of ADHD, verified through structured clinical evaluation. To ensure task comprehension and protocol tolerance, all participants must meet a minimum cognitive ability threshold based on a brief IQ screening.
Participants are randomly assigned to receive either active iTBS or sham stimulation. In the sham condition, the procedures and equipment appear identical, but the stimulation coil is positioned in a way that does not affect brain activity. This ensures that results can be attributed to the stimulation itself rather than expectations or placebo effects. Both participants and researchers conducting assessments are unaware of group assignments to maintain blinding.
Each participant undergoes ten sessions of either active or sham iTBS, typically spaced across two weeks. The stimulation protocol is brief-each session lasting only a few minutes-and individualized according to motor threshold testing, which ensures the intensity is appropriate and safe for each child. All procedures are delivered under professional supervision in a child-friendly environment with appropriate hearing protection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, care providers, investigators, and outcome assessors are all blinded to group assignment (active vs. sham TMS). The sham condition mimics the sound and sensation of stimulation without delivering active magnetic pulses, using an identical setup. Randomization and group codes are maintained by an independent administrator and not revealed until after final data analysis. Blinding is used to reduce bias in behavioral, neurophysiological, and questionnaire-based outcomes.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-12 years at the time of enrollment.
- •Clinical diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD), any presentation type, confirmed using the Vanderbilt ADHD Diagnostic Parent Rating Scale and clinical interview.
- •Intelligence quotient (IQ) ≥ 70 as measured by the General Ability Index (GAI) from the Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V).
- •Ability to understand and follow instructions for the Attention Network Test (ANT) and stimulation procedure.
- •Stable medication regimen for ADHD (if any) for at least 4 weeks before the start of the study.
- •Written informed consent from a parent or legal guardian, and assent from the child when appropriate.
排除标准
- •History of epilepsy, seizures, or abnormal EEG suggestive of seizure risk.
- •Presence of metal implants, devices, or foreign bodies in or near the head (except dental fillings) that are contraindicated for TMS or MRI.
- •Serious neurological disorders other than ADHD (e.g., cerebral palsy, brain injury, neurodegenerative disease).
- •Severe psychiatric disorders requiring hospitalization or urgent intervention.
- •Current or past history of significant head trauma with loss of consciousness > 5 minutes.
- •Uncorrected hearing or vision problems that could interfere with task performance.
结局指标
主要结局
Change in Executive Attention Efficiency as Measured by the Attention Network Test (ANT)
时间窗: Baseline and post-intervention (within 7 days of final TMS session)
Executive attention is measured as the conflict effect (reaction time in incongruent flanker trials - reaction time in congruent flanker trials). Smaller values of reaction time difference (milliseconds, ms) reflect improved conflict resolution and executive control.
次要结局
- Change in Event-Related Potentials During ANT (EEG - N2 Component)(Baseline and up to 7 days after the final TMS session.)
- Change in Event-Related Potentials During ANT (EEG - P3 Component)(Baseline and up to 7 days after the final TMS session.)
- Change in Oscillatory EEG Power During ANT (Theta Band)(Baseline and up to 7 days after the final TMS session.)
- Change in Resting-State Prefrontal Activity - Mean Oxygenation (fNIRS)(Baseline and up to 7 days after the final TMS session.)
- Change in Resting-State Prefrontal Activity - Functional Connectivity (fNIRS)(Baseline and up to 7 days after the final TMS session.)
- Change in ADHD Symptom Severity (Vanderbilt ADHD Diagnostic Parent Rating Scale, VADPRS)(Baseline and up to 7 days after the final TMS session.)