Electromagnetic Therapy for Autism Spectrum Disorder: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Childhood Autism Rating Scale（CARS）
研究概览
简要总结
The investigators hypothesize that electromagnetic therapy (EMT) could produce greater improvement on Autism spectrum disorder (ASD) compared to the waitlist control. To test this hypothesis, a pilot randomized waitlist-controlled trial is designed to achieve the 2 aims:
- To evaluate the efficacy of EMT in improving children with ASD as measured by Childhood Autism Rating Scale (CARS) by comparing the change in CARS scores from baseline to week 12 between the two groups.
- To assess the safety of EMT by comparing the number of participants with adverse events, number of participants withdrawn and reasons of withdrawal in treatment group with those in the control group.
A pilot randomized waitlist-controlled trial is designed. A total of 30 children aged 3-12 years with a principal diagnosis of ASD will be recruited. They will be randomly assigned to Care-As Usual (CAU) and CAU+EMT groups (n = 15 each group). Participants on the CAU+EMT group will receive a total of 30 sessions of EMT within 12 weeks (2 - 3 sessions/week).Those who are initially assigned to CAU group will receive EMT for 12 weeks after they complete the trial. The post-trial treatment will serve as a compensation for their participation.
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
- None
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 3-12 years;
- •have had a principal diagnosis of ASD according to the diagnostic criteria for ASD in the DSM-5;
- •The score of CARS is 30-37 (mild to moderate ASD) at entry; and
- •his/her parents or legal guardian give a written informed consent that indicates the permission to participate in the study.
排除标准
- •Children suffer a significant comorbid congenital disease or brain injury, such as Down syndrome, mental retardation, and cerebral palsy;
- •Children have been suffering uncontrolled epilepsy or seizure;
- •Children have heart diseases;
- •Children have participated in other investigational studies in previous 3 months;
- •Children have pediatric massage or acupuncture in previous 2 months; or
- •they have severe skin lesions or scar on the areas the treatment will be performed.
结局指标
主要结局
Childhood Autism Rating Scale（CARS）
时间窗: The changes from baseline to week 12, week 24 and week 36.
CARS consists of 15 items that cover all domains of ASD symptoms: 1, relationship to people; 2, Imitation; 3, emotional response; 4, body use; 5, object use; 6, adaptation to change; 7, visual response; 8, listening response; 9, taste-smell-touch response and use; 10, fear and nervousness; 11, verbal communication; 12. non-verbal communication; 13. Activity level; 14. Level and consistency of intellectual response; 15, general impressions. Each item is scored from "1" (normal behavior) to "4" (severely abnormal behavior), with a total score ranging from 15 to 60. Scores 30-37 indicate mild to moderate ASD; 38-60 indicate severe.
次要结局
- Clinical Global Impression-Severity (CGI-S)(The changes from baseline, week 12, week 24 and week 36.)
- Clinical Global Impression Severity-Improvement (CGI-I)(The changes from baseline, week 12, week 24 and week 36.)
- Autism Treatment Evaluation Scale (ATEC)(The changes from baseline, week 12, week 24 and week 36.)
- Children's Sleep Habits Questionnaire (CSHQ)(The changes from baseline, week 12, week 24 and week 36.)
研究者
Dr. Lo Kwai Ching
Assistant Lecturer
The University of Hong Kong