Clinical trial NCT06085287: Electromagnetic Therapy for Autism Spectrum Disorder
Official title: Electromagnetic Therapy for Autism Spectrum Disorder: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism spectrum disorder
ASD
EMT
Electromagnetic therapy
Chinese Medicine
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 To assess the safety of EMT by comparing the number of participants with adverse events, number of participants withdrawn and reasons of withdrawal in treatment group with those in the control group.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

Primary outcomes:
measure: Childhood Autism Rating Scale（CARS）
timeFrame: The changes from baseline to week 12, week 24 and week 36.
Secondary outcomes:
measure: Autism Treatment Evaluation Scale (ATEC)
timeFrame: The changes from baseline, week 12, week 24 and week 36.
measure: Children's Sleep Habits Questionnaire (CSHQ)
timeFrame: The changes from baseline, week 12, week 24 and week 36.
measure: Clinical Global Impression-Severity (CGI-S)
timeFrame: The changes from baseline, week 12, week 24 and week 36.
measure: Clinical Global Impression Severity-Improvement (CGI-I)
timeFrame: The changes from baseline, week 12, week 24 and week 36.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Clinical Services Centres, The School of Chinese Medicine, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Kwai Ching Lo, PHD
role: PRINCIPAL_INVESTIGATOR
References: