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Autism Spectrum DisorderPhase 2/3NCT05927792

Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorders

A Phase 2/3 study testing repeated transcranial magnetic stimulation (continuous theta-burst stimulation) in people with Autism Spectrum Disorder, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a prospective, multicenter, randomized, single-blind controlled trial to enroll 200 children with autism spectrum disorders (ASD). The investigators hope to further explore the effectiveness of accelerated continuous theta-burst stimulation (a-cTBS) over the left primary motor cortex (M1) to improve core… Read more about this study

Who is it for?
Ages 4 to 10 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
repeated transcranial magnetic stimulation (continuous theta-burst stimulation)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
3 sitesChina
Study dates
4 Jul 2023to 31 Oct 2024
Phase
Phase 2/3
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 4 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children aged 4-10 years old
  • Meet the diagnostic criteria for ASD of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
  • ASD Diagnosis confirmed by the Autism Diagnostic Observation Schedule (ADOS) or Autism Diagnostic Interview, Revised (ADI-R)
  • IQ of 50 or above
  • Provide written informed consents

Who cannot join

  • With metal implants in the body
  • History of epilepsy or other neurological disease
  • Require surgical treatment due to structural abnormalities indicated by brain MRI
  • Diagnosed with genetic and chromosomal abnormalities
  • With psychiatric/mental disorder (e.g., very early-onset schizophrenia) other than ASD
  • Suffer from serious heart disease and/or severe hearing impairment
Show all 9Show fewer
  • Intracranial hypertension
  • Participating in other clinical trials
  • Participants who received other interventions within 4 weeks prior to enrollment.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Qilu Hospital of Shandong University

    Qilu, Shandong, 250000

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

  • Henan Children's Hospital

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorders: a Multicenter, Randomized Controlled Trial

This study is a prospective, multicenter, randomized, single-blind controlled trial to enroll 200 children with autism spectrum disorders (ASD). The investigators hope to further explore the effectiveness of accelerated continuous theta-burst stimulation (a-cTBS) over the left primary motor cortex (M1) to improve core symptoms in ASD children based on a previous open-label clinical trial.

Read the detailed description

This study is a prospective, multicenter, randomized, single-blind controlled trial. Shanghai Xinhua hospital, Qilu hospital and Zhengzhou Children's hospital expect to enroll a total of 200 children with autism spectrum disorders (ASD) to participate in this trial.

The children seen at Department of Developmental Behavioral Child Health, who meet the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5) ASD diagnostic criteria and strict inclusion/exclusion criteria, can be enrolled for the intervention after informed consent.

At each study center, participants will be randomized into intervention group and sham group stratified by IQ level. The participants, their legal guardians, and the assessors were unaware of the grouping except for the intervention operator (single-blind).

During the trial, participants in intervention group will receive accelerated continuous theta-burst stimulation (a-cTBS) on the left primary motor cortex (M1) for 5 consecutive days. The sham group will be stimulated with a pseudo-stimulation coil, which emitted sounds with the same intensity, rhythm and vibratory sensation as the real stimulation, and the intervention target, duration and frequency are the same as the real intervention group.

All participants need to complete clinical assessments within 2 weeks before the cTBS intervention (pre-cTBS), repeated within 3 days after the completion of the cTBS course (post-cTBS) and 1 month following the last cTBS session (one month follow-up), respectively.

The investigators hope to further explore the effectiveness of accelerated continuous theta-burst stimulation (a-cTBS) over the left primary motor cortex (M1) to improve core symptoms in ASD children based on a previous open-label clinical trial and investigate the appropriate intervention model, effective adaptation population and underlying neurological mechanisms.

Being tested
repeated transcranial magnetic stimulation (continuous theta-burst stimulation), sham repeated transcranial magnetic stimulation
Keywords
Repetitive Transcranial Magnetic Stimulation（rTMS）, Autism Spectrum Disorder, Intervention, Social Deficits, Language Function, Children
Medical subject headings
Autism Spectrum Disorder, Language

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • repeated transcranial magnetic stimulation (continuous theta-burst stimulation)Device

    Participants in intervention group will receive cTBS over the left M1for 5 consecutive days. The detailed parameters as follows: 80% of resting motor threshold (RMT), 60 cycles of 10 bursts of three pulses at 50 Hz were delivered in 2-second trains (5 Hz) with no intertrain interval (i.e. triplet standard cTBS, 1800 pulses, 120s). Stimulation sessions were delivered hourly, 10 sessions were applied per day (18,000 pulses/day).

  • sham repeated transcranial magnetic stimulationDevice

    The sham group will be stimulated with a pseudo-stimulation coil, which emitted sounds with the same intensity, rhythm and vibratory sensation as the real stimulation, and the intervention target, duration and frequency are the same as the real intervention group.

Study groups in NCT05927792
Study groupRoleWhat they receive
Intervention GroupExperimentalparticipants in intervention group will receive accelerated continuous theta-burst stimulation (a-cTBS) on the left primary motor cortex (M1) for 5 consecutive days.
Receives: Device: repeated transcranial magnetic stimulation (continuous theta-burst stimulation)
Sham GroupSham comparatorThe sham group will be stimulated with a pseudo-stimulation coil, which emitted sounds with the same intensity, rhythm and vibratory sensation as the real stimulation, and the intervention target, duration and frequency are the same as the real intervention group.
Receives: Device: sham repeated transcranial magnetic stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of Social Responsiveness Scale, Second Edition (SRS-2) scores from pre-intervention to post-intervention

    SRS provides the multi-dimensional measure of social interaction allowing the rating of social impairment in ASD. SRS generates a total score and five theoretical subscale scores (labeled social awareness, social cognition, social communication, social motivation, restricted interests and repetitive behavior), and higher scores are indicative of greater social impairment.

    Measured: within 2 weeks before the intervention (pre-intervention), within 3 days after the completion of the intervention course (post-intervention)

  2. Changes of Social Responsiveness Scale, Second Edition (SRS-2) scores from pre-intervention to 1 month follow-up

    SRS provides the multi-dimensional measure of social interaction allowing the rating of social impairment in ASD. SRS generates a total score and five theoretical subscale scores (labeled social awareness, social cognition, social communication, social motivation, restricted interests and repetitive behavior), and higher scores are indicative of greater social impairment.

    Measured: within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up)

Secondary outcomes (6)

  1. Chinese Communicative Development Inventory (CCDI)

    a parent questionnaire serves as a powerful tool to evaluate the early vocabulary development and language skills of older children with developmental disorders and the effectiveness of their interventions. CCDI yields two subscale scores, including words produced score and sentence complexity score.Higher scores suggest better language level.

    Measured: within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up)

  2. Language Comprehension Test

    Peabody Picture Vocabulary Test (PPVT) is a standard assessment tool for measuring single-word comprehension, to objectively evaluate the language ability of the children involved in our study. Higher scores suggest better language level.

    Meanwhile, a sentence-picture matching test will be administered to test children's language comprehension abilities in the syntactic domain.

    Measured: within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up)

  3. Multilingual Assessment Instrument for Narratives (MAIN)

    assess narrative comprehension and production skills of children who exhibited a certain level of expressive ability (at least can use flexible phrases).In this test, children tell or retell the stories and answer some questions, with assessors evaluating performance across four dimensions: story structure, structural complexity, internal state terms, and comprehension questions. Higher scores suggest better language level.

    Measured: within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up)

  4. Clinical Global Impression Scale (CGI)

    we used CGI-I to rate how much the patient's illness has improved or worsened relative to a baseline measurement (a seven-point scale: 1 = "very much improved" to 7 = "very much worse")

    Measured: within 3 days after the completion of the intervention course (post-intervention), 1 month following the last intervention session (one month follow-up)

  5. Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)

    The Vineland Adaptive Behavior Scales were designed to address adaptive behavior, or the personal and social skills necessary for everyday independent living. For individuals with ASDs, the Vineland can be used for tracking and reporting progress of intervention or treatment. Domains of adaptive functioning assessed with the Vineland include: Communication, Daily Living Skills, Socialization, Motor Skills. The higher scores suggest better adaptive level.

    Measured: within 2 weeks before the intervention (pre-intervention), 1 month following the last intervention session (one month follow-up)

  6. Electroencephalography (EEG)

    Electroencephalography (EEG): We plan to collect resting-state and task-related EEG data from children with ASD at baseline, after 5 days of intervention after intervention to evaluate changes in power spectrum and inter-trial phase coherence (ITPC) in the alpha and theta frequency bands at different time points. The EEG data will be collected using a 128-channel EEG system with a sampling rate of 1000 Hz and a reference electrode at Cz (central zero). Prior to data collection, we will ensure that the resistance of each channel is below 100 kΩ.

    Measured: within 2 weeks before the intervention (pre-intervention), within 2 days after the completion of the intervention course (post-intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start4 Jul 2023
  3. Primary completion25 Oct 2024
  4. Study completion31 Oct 2024

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05927792
Sponsor's protocol ID
XHEC-C-2023-043
Status last verified
May 2026
First submitted
13 Jun 2023
Last updated
19 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Study Protocol, Statistical Analysis Plan, Informed Consent Form (ICF), etc are available through contacting researchers if required.

Publications

  • Tan H, Ren T, Cao A, Fang S, Deng L, Hu B, Wang M, Cheng Y, Zhang X, Li Y, Zhang Y, Zhang L, Chen L, Zhou W, Zhang Q, Li J, Zhou X, Langley C, Luo Q, Zhang J, Sahakian BJ, Yuan TF, Li F. Accelerated continuous theta burst stimulation targeting left primary motor cortex for children with autism spectrum disorder: multicentre randomised sham controlled trial. BMJ. 2026 Apr 29;393:e086295. doi: 10.1136/bmj-2025-086295.

    PubMed 42055586

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing repeated transcranial magnetic stimulation (continuous theta-burst stimulation) in people with Autism Spectrum Disorder, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 3 sites in China.

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 9 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 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Changes of Social Responsiveness Scale, Second Edition (SRS-2) scores from pre-intervention to post-intervention (time frame: within 2 weeks before the intervention (pre-intervention), within 3 days after the completion of the intervention course (post-intervention)). The study lists 2 primary outcomes in all. 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 NCT05927792, which also lists 1 linked publication.

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 19 May 2026.

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