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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 To assess the safety of EMT by comparing the number of participants with adverse events, number of participants withdrawn and reasons of withdrawal in treatment group with those in the control group.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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 12
Healthy Volunteers: f
View:

• aged 3-12 years;

• have had a principal diagnosis of ASD according to the diagnostic criteria for ASD in the DSM-5;

• The score of CARS is 30-37 (mild to moderate ASD) at entry; and

• his/her parents or legal guardian give a written informed consent that indicates the permission to participate in the study.

Locations
Other Locations
Hong Kong Special Administrative Region
Clinical Services Centres, The School of Chinese Medicine, The University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Kwai Ching Lo, PHD
angelos@hku.hk
(852) 3917 6462
Backup
Zhang Jin Zhang, PHD
zhangzj@hku.hk
(852) 3917 6445
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Treatments
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).
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.
Related Therapeutic Areas
Sponsors
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov