Effects of Transcranial Pulse Stimulation on ASD

NCT05408793 | Completed DMC

• 1 other identifier: HongKongPU_HSEARS20220228005
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Autism Spectrum Disorder; High-functioning Autism

Keywords

efficacy and safety; transcranial pulse stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Changes in CARS scores from baseline at 3 months

Secondary Outcomes (8)

• Autistic traits

  Changes in AQ scores from baseline at 3 months

• Social deficits

  Changes in SRS from baseline at 3 months

• Asperger's Syndrome

  Changes in ASAS from baseline at 3 months

• Theory of Mind and Social Cognition

  Changes in FPRT from baseline at 3 months

• Executive Function

  Changes in Stroop test from baseline at 3 months

Study Arms (2)

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.

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.

Device: Transcranial Pulse Stimulation

Interventions

Transcranial Pulse Stimulation DEVICE

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.

Sham TPS Group; Transcranial Pulse Stimulation (TPS group)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing HongKongPolyU

Hong Kong, Hong Kong

Location

Related Publications (2)

• 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.

  PMID: 40841688 DERIVED

• Cheung 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.

  PMID: 36497688 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Teris Cheung, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind. Participants and interventionists will be blinded to the random allocation to either the verum TPS group or the sham TPS group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blinded, sham-controlled trial.

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 7, 2022
• Study Start: June 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 6, 2022
• Last Updated: March 13, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)