Electromagnetic Therapy for Autism Spectrum Disorder

Electromagnetic Therapy for Autism Spectrum Disorder: a Pilot Randomized Controlled 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 To assess the safety of EMT by comparing the number of participants with adverse events, number of participants withdrawn and reasons of withdrawal in treatment group with those in the control group.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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Device: Electromagnetic therapy

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAU+EMT groups; 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; 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.
No Intervention: CAU Group; 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?

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.

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Kwai Ching Lo, PHD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Actual): December 5, 2024
• Study Completion (Actual): December 5, 2024

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: ASD; EMT; Chinese Medicine; Autism spectrum disorder; Electromagnetic therapy
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Therapeutics; Magnetic Field Therapy
• Other Study ID Numbers: UW 23-273

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No