Electromagnetic Therapy for Autism Spectrum Disorder

Last updated: May 7, 2024
Sponsor: The University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asperger's Disorder

Autism

Autism Spectrum Disorder (Asd)

Treatment

Electromagnetic therapy

Clinical Study ID

NCT06085287
UW 23-273
  • Ages 3-12
  • All Genders

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 To assess the safety of EMT by comparing the number of participants with adverse events, number of participants withdrawn and reasons of withdrawal in treatment group with those in the control group.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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. aged 3-12 years;
  2. have had a principal diagnosis of ASD according to the diagnostic criteria for ASD inthe 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 thepermission to participate in the study.

Exclusion

Exclusion Criteria:

  1. Children suffer a significant comorbid congenital disease or brain injury, such asDown 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 Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Electromagnetic therapy
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

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

    Hong Kong,
    Hong Kong

    Active - Recruiting

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