Electromagnetic Therapy for Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06085287
• Other study ID #: UW 23-273
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: The University of Hong Kong
• Contact: Kwai Ching Lo, PHD
• Phone: (852) 3917 6462
• Email: angelos[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 To assess the safety of EMT by comparing the number of participants with adverse events, number of participants withdrawn and reasons of withdrawal in treatment group with those in the control group.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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

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

Country	Name	City	State
Hong Kong	Clinical Services Centres, The School of Chinese Medicine, The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.