RECRUITINGINTERVENTIONAL

Electromagnetic Therapy for Autism Spectrum Disorder

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

About This Trial

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: 1. 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. 2. To assess the safety of EMT by comparing the number of participants with adverse events, number of participants withdrawn and reasons of withdrawal in treatment group with those in the control group.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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. aged 3-12 years; 2. have had a principal diagnosis of ASD according to the diagnostic criteria for ASD in the DSM-5; 3. The score of CARS is 30-37 (mild to moderate ASD) at entry; and 4. his/her parents or legal guardian give a written willing to sign a consent form that indicates the permission to participate in the study. Who Should NOT Join This Trial: 1. Children suffer a significant comorbid congenital disease or brain injury, such as Down syndrome, mental retardation, and cerebral palsy; 2. Children have been suffering uncontrolled epilepsy or seizure; 3. Children have heart diseases; 4. Children have participated in other investigational studies in previous 3 months; 5. Children have pediatric massage or acupuncture in previous 2 months; or 6. they have severe skin lesions or scar on the areas the treatment will be performed. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. aged 3-12 years; 2. have had a principal diagnosis of ASD according to the diagnostic criteria for ASD in the DSM-5; 3. The score of CARS is 30-37 (mild to moderate ASD) at entry; and 4. his/her parents or legal guardian give a written informed consent that indicates the permission to participate in the study. Exclusion Criteria: 1. Children suffer a significant comorbid congenital disease or brain injury, such as Down syndrome, mental retardation, and cerebral palsy; 2. Children have been suffering uncontrolled epilepsy or seizure; 3. Children have heart diseases; 4. Children have participated in other investigational studies in previous 3 months; 5. Children have pediatric massage or acupuncture in previous 2 months; or 6. they have severe skin lesions or scar on the areas the treatment will be performed.

Treatments Being Tested

DEVICE

Electromagnetic therapy

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.

Locations (1)

Clinical Services Centres, The School of Chinese Medicine, The University of Hong Kong

Hong Kong, Hong Kong