Electromagnetic Therapy for Autism Spectrum Disorder

NCT ID: NCT06085287

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-12-31

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 To assess the safety of EMT by comparing the number of participants with adverse events, number of participants withdrawn and reasons of withdrawal in treatment group with those in the control group.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

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Electromagnetic therapy

Intervention Type: DEVICE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Lo Kwai Ching

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kwai Ching Lo, PHD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Kwai Ching Lo, PHD

Role: CONTACT

angelos@hku.hk

(852) 3917 6462

Zhang Jin Zhang, PHD

Role: CONTACT

zhangzj@hku.hk

(852) 3917 6445

Facility Contacts

Kwai Ching Lo, PHD

Role: primary

angelos@hku.hk

(852) 3917 6462

Other Identifiers

UW 23-273

Identifier Type: -

Identifier Source: org_study_id