Electromagnetic Therapy for Autism Spectrum Disorder

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Device: Electromagnetic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06085287

UW 23-273

Details and patient eligibility

About

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 To assess the safety of EMT by comparing the number of participants with adverse events, number of participants withdrawn and reasons of withdrawal in treatment group with those in the control group.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

Enrollment: 30 estimated patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

CAU+EMT groups

Experimental group

Description:

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).

Treatment:

Device: Electromagnetic therapy

CAU Group

No Intervention group

Description:

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.