Electromagnetic Therapy for Autism Spectrum Disorder

Study Overview
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Brief Summary
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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 To assess the safety of EMT by comparing the number of participants with adverse events, number of participants withdrawn and reasons of withdrawal in treatment group with those in the control group.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.

Official Title
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Electromagnetic Therapy for Autism Spectrum Disorder: a Pilot Randomized Controlled Trial

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Device: Electromagnetic therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAU+EMT groups<br>CAU+EMT group will continue their current interventions and medications as usual. The existing interventions and medications will be recorded and serve as covariates included in outcome analysis. Besides, CAU+EMT group will receive a total of 30 sessions of EMT within 12 weeks (2 - 3 sessions/week). | Device: Electromagnetic therapy<br>* Electromagnetic therapy will be performed using an electromagnetic stimulator (Smart Cap). Chinese medicine practitioners who have at least 3 years of experience will conduct EMT after training. Each session of EMT will take 20-25 min, with 2-3 sessions per week, total of 30 sessions finished within 12 weeks.<br>|
| No Intervention: CAU Group<br>CAU group will continue their current interventions and medications as usual. The existing interventions and medications will be recorded and serve as covariates included in outcome analysis.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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Childhood Autism Rating Scale（CARS） | 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. | The changes from baseline to week 12, week 24 and week 36. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autism Treatment Evaluation Scale (ATEC) | Autism Treatment Evaluation Scale is evaluated by a parent and serve as supplementary to CARS.The minimum vale of ATEC is 0 and the maximum value is 197, the higher the score the worse the outcome. | The changes from baseline, week 12, week 24 and week 36. | 
| Children's Sleep Habits Questionnaire (CSHQ) | The minimum vale of CSHQ is 0 and the maximum value is 66, the higher the score the worse the outcome. | The changes from baseline, week 12, week 24 and week 36. | 
| Clinical Global Impression-Severity (CGI-S) | The minimum vale of CGI-S is 0 and the maximum value is 7, the higher the score the worse the outcome. | The changes from baseline, week 12, week 24 and week 36. | 
| Clinical Global Impression Severity-Improvement (CGI-I) | The minimum vale of CGI-I is 0 and the maximum value is 7, the higher the score the worse the outcome. | The changes from baseline, week 12, week 24 and week 36. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASD, Autism spectrum disorder, EMT, Electromagnetic therapy, Chinese Medicine