Transcranial Electrical Stimulation Modalities for the Treatment of Clinical Symptoms and Cognitive Deficits in Attention-deficit Hyperactivity Disorder Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- ADHD symptoms- Clinical rating scale
研究概览
简要总结
This project investigates the efficacy of transcranial electrical stimulation (tES) modalities, specifically transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS), for treating Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents.
详细描述
This project aims to evaluate the therapeutic potential of transcranial electrical stimulation (tES) modalities, specifically transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS), as innovative, non-invasive interventions for managing Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. ADHD is a neurodevelopmental disorder characterized by persistent inattention, hyperactivity, and impulsivity that impair daily functioning. Conventional treatments, such as pharmacological interventions and behavioral therapies, may have limitations, including side effects or variable efficacy, prompting the exploration of neuromodulation techniques like tES.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ADHD by a licensed psychiatrist and a behavioral checklist
- •being 7-18 years old
- •providing written informed consent signed by parents
排除标准
- •comorbidity with other neurodevelopmental disorders
- •Comorbidity with other neurological disorders
- •previous history of neurosurgery
- •Presence of any ferromagnetic metal in the head
- •implanted medical devices in the head or neck region
- •history of non-controlled epilepsy with seizures in the last year
研究组 & 干预措施
active tDCS group
This group receives Transcranial Direct Current Stimulation (tDCS). tDCS delivers a constant, low-intensity direct current (typically 1-2 mA) through electrodes placed on the scalp. The anode (positive electrode) increases cortical excitability by depolarizing neurons, while the cathode (negative electrode) decreases excitability by hyperpolarizing neurons.
干预措施: transcranial electrical stimulation (Device)
active tACS group
This group receives Transcranial Alternating Current Stimulation (tACS). tACS applies an oscillating current at specific frequencies (e.g., 1-100 Hz) to entrain or synchronize neural oscillations. By aligning the stimulation frequency with endogenous brain rhythms (e.g., theta or gamma bands), tACS can modulate network dynamics, potentially normalizing aberrant oscillatory patterns associated with disorders like ADHD.
干预措施: transcranial electrical stimulation (Device)
sham group
This group receives sham stimulation. The stimulation duration is for 1 minuetand the device will be turned off after the stimulation
干预措施: transcranial electrical stimulation (Device)
结局指标
主要结局
ADHD symptoms- Clinical rating scale
时间窗: Baseline, week 2, up to 1 month after the intervention
ADHD symptoms will be assessed using a DSM-based structured interview. This approach involves a systematic, standardized method to evaluate the presence and severity of ADHD symptoms based on the diagnostic criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders (DSM), likely the DSM-5, which is widely used for diagnosing ADHD.
次要结局
- electroencephalogram (EEG) functional connectivity(Baseline, week 2)
- Executive function- Performance accuracy and reaction time(Baseline, week 2, up to 1 month after the intervention)
- electroencephalogram (EEG) power(Baseline, week 2)
研究者
Mohammad Ali Salehinejad
Principal Investigator
The National Brain Mapping Laboratory (NBML)