The Efficacy of Dual-target iTBS in Youth With Attention-Deficit/Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Effectiveness as measured by SNAP-IV Parent Rating Scale (assessing inattention/hyperactivity-impulsivity)
研究概览
简要总结
This study will employ accelerated intermittent theta burst stimulation (aiTBS) targeting two transcranial magnetic stimulation (TMS) sites: the right inferior frontal gyrus and left inferior parietal lobule.
详细描述
ADHD is the most common neurodevelopmental disorder in childhood. First-line clinical treatments primarily rely on psychostimulants, yet approximately 30% of adolescents with ADHD show inadequate response to current therapies. There is an urgent need to develop novel, practical, and sensitive intervention strategies.
Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive technique that modulates neural activity via magnetic fields applied to brain regions beneath the skull, can induce long-lasting positive changes in neuroplasticity. This provides an alternative therapeutic approach for ADHD. In clinical research, rTMS has demonstrated potential value in treating children with ADHD. Notably, current studies have limitations: lack of control groups makes it difficult to exclude placebo effects, and the commonly used DLPFC target shows suboptimal efficacy in improving both clinical symptoms and cognitive functions, indicating room for improvement.
This study will be conducted in two phases:
- Phase 1 is an open-label, single-arm study to explore the preliminary efficacy, safety, and acceptability of aiTBS for youth with ADHD.
- Phase 2 is a randomized, double-masked, controlled trial that will rigorously validate the efficacy and safety of dual-target aiTBS and establish causal conclusions through a controlled design.
The decision to proceed depends on Phase 1 results:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Phase 1：open label；Phase 2: double-blind masking
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ADHD Diagnosis: Meets the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
- •Inadequate Response to Medication: After a full course of pharmacological treatment, the SNAP-IV Parent Rating Scale (first 18 items, assessing inattention/hyperactivity-impulsivity) score >1, and the Clinical Global Impression-Severity Scale (CGI-S) score >2;
- •Age and Gender: 10-18 years old; males or females;
- •Intellectual Functioning: Full-scale intelligence quotient (IQ) >70 on the China-Wechsler Intelligence Scale for Children (C-WISC) (excluding participants with intellectual disability);
- •Symptom Severity: A score of ≥1.6 on either the Inattention or Hyperactivity/Impulsivity subscale of the SNAP-IV Parent Rating Scale;
- •Medication Requirements:
- •Medication-naïve or currently off medication; 2) If currently on medication, must be on a stable medication regimen for at least 4 weeks prior to the baseline visit and throughout the study duration; 3) Prohibited medications: Psychostimulants;
- •Right-handed.
排除标准
- •Contraindications for TMS therapy include epilepsy, cardiac pacemakers, cochlear implants, and metal implants.
- •Contraindications for MRI include metal implants in the body, claustrophobia, and tattoos.
- •Significant medical history: history of epilepsy, organic brain disorders, traumatic brain injury (TBI), or severe physical illnesses.
- •Behavioral risks: history of violent or suicidal behavior.
- •Comorbid neurodevelopmental disorders, such as autism spectrum disorder (ASD), tic disorders, etc.
- •Comorbid psychiatric disorders: any other primary psychiatric disorders, except conduct disorder/oppositional defiant disorder, mild anxiety, or depression.
- •Substance abuse.
- •Currently receiving any non-medical treatments, such as cognitive behavioral therapy (CBT), neurofeedback, etc.
- •Female participants must not be pregnant or breastfeeding.
结局指标
主要结局
Effectiveness as measured by SNAP-IV Parent Rating Scale (assessing inattention/hyperactivity-impulsivity)
时间窗: ADHD symptoms will be measured before the TMS treatment, immediately after completion of the TMS treatment.
SNAP-IV is used to assess the core symptoms of ADHD (inattention, hyperactivity/impulsivity) and symptoms of oppositional defiant disorder; the total score or subscale mean scores indicate symptom severity, with higher scores reflecting more pronounced symptoms.
Clinical Global Impression-Severity Scale (CGI)
时间窗: GCI will be measured before the TMS treatment, immediately after completion of the TMS treatment.
CGI is used to evaluate disease severity and treatment response.
次要结局
- Safety as measured by number of participants with Adverse Events(Each afternoon after treatment during the 5 days of treatment)
- Acceptability as assessed by treatment-related dropout rates(Each afternoon after treatment during the 5 days of treatment)
- BRIEF（Behavior Rating Inventory of Executive Function）(Will be measured before the TMS treatment, immediately after completion of the TMS treatment.)
- A cognitive task battery(Will be measured before the TMS treatment, immediately after completion of the TMS treatment.)
- PedsQL（Pediatric Quality of Life Inventory）(Will be measured before the TMS treatment, immediately after completion of the TMS treatment.)
- Cortical excitability and cortical inhibition function indicators(Will be measured before the TMS treatment, immediately after completion of the TMS treatment.)