Autism Spectrum DisorderNCT06085287
Electromagnetic Therapy for Autism Spectrum Disorder
A study testing Electromagnetic therapy in people with Autism Spectrum Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Electromagnetic therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 4 Mar 2024to 5 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Children suffer a significant comorbid congenital disease or brain injury, such as Down syndrome, mental retardation, and cerebral palsy;
- Children have been suffering uncontrolled epilepsy or seizure;
- Children have heart diseases;
- Children have participated in other investigational studies in previous 3 months;
- Children have pediatric massage or acupuncture in previous 2 months; or
- they have severe skin lesions or scar on the areas the treatment will be performed.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Clinical Services Centres, The School of Chinese Medicine, The University of Hong Kong
Hong Kong
About this study
Official title: Electromagnetic Therapy for Autism Spectrum Disorder: a Pilot Randomized Controlled Trial
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:
- 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.
- 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
- Being tested
- Electromagnetic therapy
- Keywords
- Autism spectrum disorder, ASD, EMT, Electromagnetic therapy, Chinese Medicine
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CAU+EMT groups | Experimental | 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). Receives: Device: Electromagnetic therapy |
| CAU Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The changes from baseline to week 12, week 24 and week 36.
Secondary outcomes (4)
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.
Measured: The changes from baseline, week 12, week 24 and week 36.
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.
Measured: The changes from baseline, week 12, week 24 and week 36.
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.
Measured: The changes from baseline, week 12, week 24 and week 36.
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.
Measured: The changes from baseline, week 12, week 24 and week 36.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start4 Mar 2024
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lo Kwai Ching, The University of Hong Kong
- Investigators
- Kwai Ching Lo, PHD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085287
- Sponsor's protocol ID
- UW 23-273
- Status last verified
- Apr 2026
- First submitted
- 6 Jul 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromagnetic Therapy for Autism Spectrum Disorder: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06085287
- Acronym / sponsor ID
- UW 23-273
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism spectrum disorder, ASD, EMT, Electromagnetic therapy, Chinese Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAU+EMT groups | Experimental | Device: Electromagnetic therapyCAU+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). |
| CAU Group | No intervention | –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. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Children suffer a significant comorbid congenital disease or brain injury, such as Down syndrome, mental retardation, and cerebral palsy;
- Children have been suffering uncontrolled epilepsy or seizure;
- Children have heart diseases;
- Children have participated in other investigational studies in previous 3 months;
- Children have pediatric massage or acupuncture in previous 2 months; or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromagnetic therapyElectromagnetic 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. | Device | CAU+EMT groups |
Primary outcome
Childhood Autism Rating Scale（CARS）
Time frame: The changes from baseline to week 12, week 24 and week 36.
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.
4 secondary outcomes
Autism Treatment Evaluation Scale (ATEC)
Time frame: The changes from baseline, week 12, week 24 and week 36.
Children's Sleep Habits Questionnaire (CSHQ)
Time frame: The changes from baseline, week 12, week 24 and week 36.
Clinical Global Impression-Severity (CGI-S)
Time frame: The changes from baseline, week 12, week 24 and week 36.
Clinical Global Impression Severity-Improvement (CGI-I)
Time frame: The changes from baseline, week 12, week 24 and week 36.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwai Ching Lo, PHD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromagnetic therapy in people with Autism Spectrum Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childhood Autism Rating Scale（CARS） (time frame: The changes from baseline to week 12, week 24 and week 36.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.