Autism Spectrum DisorderNCT05408793
Effects of Transcranial Pulse Stimulation on ASD
A study testing Transcranial Pulse Stimulation in people with Autism Spectrum Disorder and High-functioning Autism, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The aim of this study is to evaluate the efficacy and tolerability of TPS on young adolescents with ASD. Methods: This is a two-armed, randomized, double-blinded, sham-controlled trial. Sampling: A total number of 36 subjects, aged between 12 to 17, diagnosed with ASD, will be recruited. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Autism Spectrum Disorder, High-functioning Autism
- What is being tested?
- Transcranial Pulse Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2022to 6 Dec 2022
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 12 -17 years of age
- Chinese ethnicity
- Diagnosis of Autistic Spectrum Disorder that meets the criteria of the 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- No change in their management including medications or non-pharmacological intervention
- Currently taking prescribed psychotropic medications for ≥ 3 months
Who cannot join
- A DSM-5 diagnosis other than ASD
- Concomitant major medical or neurological conditions, such as significant global developmental delay, skull defect, abnormal mass or tumor, or epilepsy
- A CARS score ≤ 30 (i.e., no ASD)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Efficacy of Transcranial Pulse Stimulation (TPS) on Individuals with Autism Spectrum Disorder (ASD)- a Double-blinded, Randomized, Sham-controlled Trial
The aim of this study is to evaluate the efficacy and tolerability of TPS on young adolescents with ASD. Methods: This is a two-armed, randomized, double-blinded, sham-controlled trial. Sampling: A total number of 36 subjects, aged between 12 to 17, diagnosed with ASD, will be recruited. Individuals with a Childhood of Autism Rating Scale (CARS) score ≤ 30 (i.e., no ASD) will be excluded. Recruitment: Subjects will be recruited from the community. Block randomization will be performed to allocate subjects to either the verum TPS group or the sham TPS group on a 1: 1 ratio. Interventionists and subjects will be blinded in the randomization process. Intervention: Intervention: Six 30-minures TPS sessions will be delivered to the verum TPS group (800 pulse in each session, total: 4800 pulse) in consecutive two weeks. The treatment brain region is targeted at the right temporoparietal junction (rTPJ). The sham- controlled group will be given 6 sham TPS sessions. Data collection: All participants are required to undertake pre-and-post fMRI and resting-MRI before the TPS procedures. Outcomes: Primary outcome of this study is CARS, and secondary outcomes include Autism Spectrum Quotient (AQ), Australian scale for Asperger's syndrome (ASAS), Social Responsive Scale (SRS), Faux Pas Recognition Test (FPRT), Stroop test, working memory, Clinical global impression - severity and improvement scale (CGI-S and CGI -I) and neuroimaging. All outcome measures will be assessed at baseline, two weeks immediately after intervention and at 1-month and 3-months follow-up.
Read the detailed description
Primary objective:
- Participants in the verum TPS group will have a significant reduction in CARS score at posttreatment compared with the sham TPS group. Secondary objectives:
- Participants in the verum TPS group will have significant improvement in Autism Spectrum Quotient (AQ), compared with the sham TPS group.
- Participants in the verum TPS group will have significant improvement in the Social Responsiveness Scale (SRS), compared with the sham TPS group.
- Participants in the verum TPS group will have significant improvement in Faux Pas Recognition Test, compared with the sham TPS group.
- Participants in the verum TPS group will have significant improvement in Stroop test, compared with the sham TPS group.
- Participants in the verum TPS group will have significant improvement in Clinical global impression - severity and improvement scale (CGI-S and CGI -I) compared with the sham TPS group.
- Participants in the verum TPS group will have significant brain function connectivity at posttreatment fMRI and resting-state MRI compared to the sham TPS group.
Sample size Based on an RCT with similar design, the estimated effect size of rTMS is 0.5. By adapting an ANOVA 2x2 repeated measures with 95% significance and a power of 0.8, a sample size of 36 will be required in total (18 subjects per group).
Research plan and Methodology Methods Trial Design: In this study, the investigators will use a double-blind randomized controlled trial design with two-armed repeated measures. The trial design complies with the Consolidated Standards of Reporting Trials (CONSORT) statement. In this two-armed design, investigators will use TPS as an intervention group and a waitlist control group. A sham-control group is appropriate for comparing the effect of the TPS on the intervention group to that of those not receiving the TPS treatment at the same timepoints Both groups will be measured at baseline (T1), immediately after the intervention (T2), at the 1-month (T3) and 3-month follow-up (T4). Based on the previous studies, a 3-month follow-up is sufficient to assess the long-term sustainability of the TPS intervention.
Intervention (Transcranial Pulse Stimulation) Purpose of the intervention: The key tenets of the TPS intervention is neuromodulation, i.e., using ultrasound-based brain stimulation techniques to modulate the human brain in a focal and targeted manner. Intervention dose: Each participant should have the pre-treatment MRI scan performed in the University Research Facility in Behavioural and Systems Neuroscience, PolyU prior coming to the first intervention session. All participants (both TPS group and the sham-control group) will receive six 30 minute-TPS sessions (800 pulse in each session, total: 4800 pulse) in 2 weeks' time. Participants will be followed up immediately after post-stimulation in Week 2, and at 1-month and 3- month period after the intervention. The investigators believe that a 2-week TPS intervention is sufficient enough to test the effects of TPS on autism symptoms.
- Conditions
- Autism Spectrum Disorder, High-functioning Autism
- Being tested
- Transcranial Pulse Stimulation
- Keywords
- efficacy and safety, transcranial pulse stimulation
- 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.
Transcranial Pulse StimulationDevice
A total of 36 participants (both TPS group and the sham-control group) will receive six 30 minute-TPS sessions (800 pulse in each session, total: 4800 pulse) in 2 weeks' time (i.e., 3 sessions (Monday, Wednesday, Friday) per week, total: 3 hours), on a 1: 1 allocation ratio. Participants will be followed up immediately after the post-stimulation and at 1-month and 3-month period after the intervention. A 2-week TPS intervention alongside with 3-month follow-up is sufficient enough to test the effects of TPS on autism symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Pulse Stimulation (TPS group) | Experimental | Subjects in the TPS group will be given 6 verum TPS sessions (Pulse: 800 / session) across two weeks time, with 3 sessions per week. Receives: Device: Transcranial Pulse Stimulation |
| Sham TPS Group | Sham comparator | Subjects in the Sham TPS group will be given 6 sham TPS sessions across two weeks time, with 3 sessions per week. Receives: Device: Transcranial Pulse Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism severity
The Childhood Autism Rating Scale (CARS) is a 15-item behavioral rating scale developed to identify autism and examine its severity. Total scores range from a low of 15 to a high of 60; scores below 30 indicate that the individual is in the non-autistic range, scores between 30 and 36.5 indicate mild to moderate autism, and scores from 37 to 60 indicate severe autism.
Measured: Changes in CARS scores from baseline at 3 months
Secondary outcomes (8)
Autistic traits
Autism Spectrum Quotient (AQ) - adolescent version is a quick and quantitative self-report instrument for assessing how many autistic traits any adult has. The minimum score on the AQ is 0 and the maximum 50.
Measured: Changes in AQ scores from baseline at 3 months
Social deficits
The Social Responsiveness Scale (SRS) is an instrument measuring the continuum of autism symptom severity which is commonly used in children and adolescents between the ages of 4 and 18 years. Parents rate on each item on a 4-item Likert scale (0-4). The higher the scores, the more severe the social deficits.
Measured: Changes in SRS from baseline at 3 months
Asperger's Syndrome
Australian scale for Asperger's syndrome (ASAS) is a scale used to screen the behaviours and abilities indicative of Asperger's Syndrome in subjects older than 6 years old. It has 25 item and can be rated by parents/teachers/professionals who know the child.
Measured: Changes in ASAS from baseline at 3 months
Theory of Mind and Social Cognition
Faux Pas Recognition Test (FPRT) is a very common advanced test to measure the theory of mind and social cognition
Measured: Changes in FPRT from baseline at 3 months
Executive Function
Stroop test is commonly used to assess the inhibition control component of executive function. It is testing the subject's ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute.
Measured: Changes in Stroop test from baseline at 3 months
Working memory
Working Memory Test Battery (WMTB), which includes two verbal storage-only tasks (i.e. digital recall and word list recall), two complex memory span tasks (i.e. backward digit recall and counting recall), and two visuospatial storage tasks (block recall and variant- visual-pattern test).
Measured: Changes in WMTB from baseline at 3 months
Clinical Global Impression
CGI-S is a 7-point clinician rating scale is based upon observed and reported symptoms, behaviour, and function in the past seven days. CGI-I is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Measured: Changes in WMTB from baseline at 3 months
Neuroimaging
Participants will receive pre and post treatment MRI scan to measure any changes in structural and functional connectivity changes in the brain.
Measured: MRI will be assessed at baseline at immediately and 2 weeks after post-stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Jun 2022
- Primary completion30 Nov 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Model description
- This is a randomized, double-blinded, sham-controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teris Cheung, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408793
- Sponsor's protocol ID
- HongKongPU_HSEARS20220228005
- Status last verified
- Sep 2024
- First submitted
- 31 May 2022
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsu CL, Matt E, Fong TKH, Lam JYT, Chau B, Cheng CPW, Beisteiner R, Cheung T. Associations Between Brain Network Connectivity and Cognitive Measures in Autism Spectrum Disorder: A Post Hoc Analysis of a Parent Study "Evaluating the Safety and Efficacy of Transcranial Pulse Stimulation on Autism Spectrum Disorder". Autism Res. 2025 Oct;18(10):1965-1977. doi: 10.1002/aur.70093. Epub 2025 Aug 21.
PubMed 40841688Cheung T, Ho YS, Fong KH, Lam YTJ, Li MH, Tse AC, Li CT, Cheng CP, Beisteiner R. Evaluating the Safety and Efficacy of Transcranial Pulse Stimulation on Autism Spectrum Disorder: A Double-Blinded, Randomized, Sham-Controlled Trial Protocol. Int J Environ Res Public Health. 2022 Nov 24;19(23):15614. doi: 10.3390/ijerph192315614.
PubMed 36497688
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Transcranial Pulse Stimulation (TPS) on Individuals with Autism Spectrum Disorder (ASD)- a Double-blinded, Randomized, Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT05408793
- Acronym / sponsor ID
- HongKongPU_HSEARS20220228005
- Conditions
- Autism Spectrum Disorder, High-functioning Autism
- Keywords
- efficacy and safety, transcranial pulse stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 7 Jun 2022 (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 aim of this study is to evaluate the efficacy and tolerability of TPS on young adolescents with ASD. Methods: This is a two-armed, randomized, double-blinded, sham-controlled trial. Sampling: A total number of 36 subjects, aged between 12 to 17, diagnosed with ASD, will be recruited. Individuals with a Childhood of Autism Rating Scale (CARS) score ≤ 30 (i.e., no ASD) will be excluded. Recruitment: Subjects will be recruited from the community. Block randomization will be performed to allocate subjects to either the verum TPS group or the sham TPS group on a 1: 1 ratio. Interventionists and subjects will be blinded in the randomization process. Intervention: Intervention: Six 30-minures TPS sessions will be delivered to the verum TPS group (800 pulse in each session, total: 4800 pulse) in consecutive two weeks. The treatment brain region is targeted at the right temporoparietal junction (rTPJ). The sham- controlled group will be given 6 sham TPS sessions. Data collection: All participants are required to undertake pre-and-post fMRI and resting-MRI before the TPS procedures. Outcomes: Primary outcome of this study is CARS, and secondary outcomes include Autism Spectrum Quotient (AQ), Australian scale for Asperger's syndrome (ASAS), Social Responsive Scale (SRS), Faux Pas Recognition Test (FPRT), Stroop test, working memory, Clinical global impression - severity and improvement scale (CGI-S and CGI -I) and neuroimaging. All outcome measures will be assessed at baseline, two weeks immediately after intervention and at 1-month and 3-months follow-up.
Detailed description
Primary objective:
- Participants in the verum TPS group will have a significant reduction in CARS score at posttreatment compared with the sham TPS group. Secondary objectives:
- Participants in the verum TPS group will have significant improvement in Autism Spectrum Quotient (AQ), compared with the sham TPS group.
- Participants in the verum TPS group will have significant improvement in the Social Responsiveness Scale (SRS), compared with the sham TPS group.
- Participants in the verum TPS group will have significant improvement in Faux Pas Recognition Test, compared with the sham TPS group.
- Participants in the verum TPS group will have significant improvement in Stroop test, compared with the sham TPS group.
- Participants in the verum TPS group will have significant improvement in Clinical global impression - severity and improvement scale (CGI-S and CGI -I) compared with the sham TPS group.
- Participants in the verum TPS group will have significant brain function connectivity at posttreatment fMRI and resting-state MRI compared to the sham TPS group.
Sample size Based on an RCT with similar design, the estimated effect size of rTMS is 0.5. By adapting an ANOVA 2x2 repeated measures with 95% significance and a power of 0.8, a sample size of 36 will be required in total (18 subjects per group).
Research plan and Methodology Methods Trial Design: In this study, the investigators will use a double-blind randomized controlled trial design with two-armed repeated measures. The trial design complies with the Consolidated Standards of Reporting Trials (CONSORT) statement. In this two-armed design, investigators will use TPS as an intervention group and a waitlist control group. A sham-control group is appropriate for comparing the effect of the TPS on the intervention group to that of those not receiving the TPS treatment at the same timepoints Both groups will be measured at baseline (T1), immediately after the intervention (T2), at the 1-month (T3) and 3-month follow-up (T4). Based on the previous studies, a 3-month follow-up is sufficient to assess the long-term sustainability of the TPS intervention.
Intervention (Transcranial Pulse Stimulation) Purpose of the intervention: The key tenets of the TPS intervention is neuromodulation, i.e., using ultrasound-based brain stimulation techniques to modulate the human brain in a focal and targeted manner. Intervention dose: Each participant should have the pre-treatment MRI scan performed in the University Research Facility in Behavioural and Systems Neuroscience, PolyU prior coming to the first intervention session. All participants (both TPS group and the sham-control group) will receive six 30 minute-TPS sessions (800 pulse in each session, total: 4800 pulse) in 2 weeks' time. Participants will be followed up immediately after post-stimulation in Week 2, and at 1-month and 3- month period after the intervention. The investigators believe that a 2-week TPS intervention is sufficient enough to test the effects of TPS on autism symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a randomized, double-blinded, sham-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Transcranial Pulse Stimulation (TPS group) | Experimental | Device: Transcranial Pulse StimulationSubjects in the TPS group will be given 6 verum TPS sessions (Pulse: 800 / session) across two weeks time, with 3 sessions per week. |
| Sham TPS Group | Sham comparator | Device: Transcranial Pulse StimulationSubjects in the Sham TPS group will be given 6 sham TPS sessions across two weeks time, with 3 sessions per week. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 12 -17 years of age
- Chinese ethnicity
- Diagnosis of Autistic Spectrum Disorder that meets the criteria of the 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- No change in their management including medications or non-pharmacological intervention
- Currently taking prescribed psychotropic medications for ≥ 3 months
Key exclusion criteria (3 listed)
- A DSM-5 diagnosis other than ASD
- Concomitant major medical or neurological conditions, such as significant global developmental delay, skull defect, abnormal mass or tumor, or epilepsy
- A CARS score ≤ 30 (i.e., no ASD)
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 |
|---|---|---|
| Transcranial Pulse StimulationA total of 36 participants (both TPS group and the sham-control group) will receive six 30 minute-TPS sessions (800 pulse in each session, total: 4800 pulse) in 2 weeks' time (i.e., 3 sessions (Monday, Wednesday, Friday) per week, total: 3 hours), on a 1: 1 allocation ratio. Participants will be followed up immediately after the post-stimulation and at 1-month and 3-month period after the intervention. A 2-week TPS intervention alongside with 3-month follow-up is sufficient enough to test the effects of TPS on autism symptoms. | Device | Sham TPS Group, Transcranial Pulse Stimulation (TPS group) |
Primary outcome
Autism severity
Time frame: Changes in CARS scores from baseline at 3 months
The Childhood Autism Rating Scale (CARS) is a 15-item behavioral rating scale developed to identify autism and examine its severity. Total scores range from a low of 15 to a high of 60; scores below 30 indicate that the individual is in the non-autistic range, scores between 30 and 36.5 indicate mild to moderate autism, and scores from 37 to 60 indicate severe autism.
8 secondary outcomes
Autistic traits
Time frame: Changes in AQ scores from baseline at 3 months
Social deficits
Time frame: Changes in SRS from baseline at 3 months
Asperger's Syndrome
Time frame: Changes in ASAS from baseline at 3 months
Theory of Mind and Social Cognition
Time frame: Changes in FPRT from baseline at 3 months
Executive Function
Time frame: Changes in Stroop test from baseline at 3 months
Working memory
Time frame: Changes in WMTB from baseline at 3 months
Clinical Global Impression
Time frame: Changes in WMTB from baseline at 3 months
Neuroimaging
Time frame: MRI will be assessed at baseline at immediately and 2 weeks after post-stimulation
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 13 Mar 2025.
- Derived from this study: PubMed 40841688Hsu CL, Matt E, Fong TKH, Lam JYT, Chau B, Cheng CPW, Beisteiner R, Cheung T. Associations Between Brain Network Connectivity and Cognitive Measures in Autism Spectrum Disorder: A Post Hoc Analysis of a Parent Study "Evaluating the Safety and Efficacy of Transcranial Pulse Stimulation on Autism Spectrum Disorder". Autism Res. 2025 Oct;18(10):1965-1977. doi: 10.1002/aur.70093. Epub 2025 Aug 21.
- Derived from this study: PubMed 36497688Cheung T, Ho YS, Fong KH, Lam YTJ, Li MH, Tse AC, Li CT, Cheng CP, Beisteiner R. Evaluating the Safety and Efficacy of Transcranial Pulse Stimulation on Autism Spectrum Disorder: A Double-Blinded, Randomized, Sham-Controlled Trial Protocol. Int J Environ Res Public Health. 2022 Nov 24;19(23):15614. doi: 10.3390/ijerph192315614.
- Individual participant dataSharing planned: No
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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.
Teris Cheung, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Pulse Stimulation in people with Autism Spectrum Disorder and High-functioning Autism, run by The Hong Kong Polytechnic University 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 5 inclusion and 3 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 13 Mar 2025. 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. Some participants in this study may receive a placebo. 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?
Autism severity (time frame: Changes in CARS scores from baseline at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05408793, which also lists 2 linked publications.
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 13 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.