Evaluating the Efficacy and Safety of Transcranial Pulse Stimulation on Young Adolescents with Attention-Deficit-Hyperactivity Disorder- a Pilot Randomized, Double-blinded, Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Attention deficit, hyperactivity impulse and oppositional defiance
研究概览
简要总结
This is the first nationwide study using Transcranial Pulse Stimulation to evaluate its efficacy and safety on 30 young adolescents with ADHD. Six verum/ shamTPS sessions will be delivered to all subjects on a 1: 1 ratio, balanced by gender and age. Attention deficit, hyperactivity, impulsivity, and oppositional defiance will be the primary outcome. Secondary outcomes include ADHD severity, frequency of inattention, hyperactivity, impulsivity, executive function and neural connectivity changes via neuroimaging. Results emerging from this study will generate new knowledge to ascertain whether TPS can be used as a top-on treatment in ADHD.
详细描述
Objectives of the study
- To evaluate the efficacy and safety of TPS on young adolescents (12-17 years) with ADHD in Hong Kong.
- To examine the association between TPS and ADHD core symptom severity, executive function, inattention, hyperactivity, impulsivity, and oppositional defiance.
- To examine the brain functional connectivity changes immediately after the 2-week TPS treatment via neuroimaging.
Expected outcomes/Hypotheses:
- Participants in the verum TPS group or the sham TPS group will have <5% somatic discomfort in the 2-week TPS intervention and that TPS is a safe intervention on young adolescents with ADHD.
- Participants in the verum TPS group will have 30% reduction in the Swanson, Nolan, and Pelham Rating Scale (SNAP IV score) (i.e., attention deficit, hyperactivity impulse and oppositional defiance) after 2-weeks TPS treatment compared with the sham TPS group and be maintained at the 1- month & 3-month follow-up.
- Participants in the verum TPS group will have 30% improvement in the ADHD symptoms and behaviour compared with the sham TPS group after 2-weeks TPS treatment and be maintained at the 1-month & 3-month follow-up.
- Participants in the verum TPS group will have 30% improvement in executive function after 2 weeks TPS treatment compared with the sham TPS group and be maintained at the 1-month & 3-month follow-up.
- Participants in the verum TPS group will have 30% improvement in both attention deficit & reduction in hyperactivity, impulsivity after 2 weeks TPS treatment compared with the sham TPS group, and be maintained at the 1 month & 3-month follow-up.
- Participants in the verum TPS group will have more brain connectivity changes after 2-weeks TPS compared with the sham TPS group and be maintained at the 1 month & 3-month follow-up.
Design: This is a two-armed, randomized, double-blind, sham-controlled trial.
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
- Double (Participant, Investigator)
盲法说明
Double-blind. Participants and interventionists will be blinded to the random allocation to either the verum TPS group or the sham TPS group.
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have a confirmed diagnosis of ADHD according to the 5th edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) of the American Psychiatric Association;
- •ethic Chinese, aged 12-17, with no co-morbidity of other mental disorders (e.g., Intellectual Disability Disorder) and organic brain diseases that affected cognitive functions;
- •no severe systemic diseases including heart, liver, lung, and kidney diseases;
- •have an IQ >80 by Stanford-Binet Intelligence Scales, 5th Edition (SB-5);
- •written consent by parents.
排除标准
- •SNAP IV score <1;
- •not taking ADHD medications in the past 2-4 weeks;
- •treated with TMS/rTMS/tDCS or electroconvulsive therapy in the past 12 months;
- •taking monoamine oxidase inhibitors in the past 14 days;
- •have a history of epilepsy, brain trauma, brain surgery/brain tumour, brain aneurysm or other concomitant unstable major medical conditions like haemophilia or other blood clotting disorders or thrombosis;
- •significant communicative impairments;
- •having metal implants in the brain treatment region /artificial cardiac pacemaker in-situ;
- •taking corticosteroid treatment within the last six weeks before the first TPS treatment;
- •have a history of micro-cavernomas.
结局指标
主要结局
Attention deficit, hyperactivity impulse and oppositional defiance
时间窗: Changes in SNAP-IV scores from baseline at 3 months
The Swanson, Nolan, and Pelham Rating Scale (SNAP IV) will be used to measure participants' attention deficit, hyperactivity impulse and oppositional defiance. SNAP IV consists of 26 items summarized into three factors: attention deficit, hyperactivity impulse, and oppositional defiance. Parents based on their general impressions on their children and rate the severity of symptoms on a Likert scale (0-3). Mean score \<1 indicate "normal" or "remission"; Mean score of 1 is defined as the demarcation for attention deficit and hyperactivity impulsivity; mean score \>2 indicated "abnormal". SNAP-IV is a reliable and valid scale used in RCTs and has good psychometric properties in the Chinese population.
次要结局
- Clinical global impression(Changes in CGI from baseline at 3 months)
- Executive function(Changes in Stroop test from baseline at 3 months)
- The ADHD Rating Scale-IV(Changes in ADHD RS-IV from baseline at 3 months)
- Neuroimaging(MRI will be assessed at baseline at immediately and 2 weeks after post-stimulation)