Autism Spectrum DisorderNCT06982586
A Prospective, Single-Center, Single-Arm, Investigator-Initiated Exploratory Clinical Trial to Assess the Safety of Repetitive Transcranial Magnetic Stimulation for Children and Adolescents With Autism Spectrum Disorder
A study testing Repetitive transcranial magentic stimulation in people with Autism Spectrum Disorder, run by Bundang CHA Hospital.
Trial summary
This is a prospective, single-center, single-arm, investigator-initiated exploratory clinical trial aimed at evaluating the safety and exploring the efficacy of a medical electromagnetic stimulator delivering low-frequency repetitive transcranial magnetic stimulation (rTMS) in children and adolescents with Autism… Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Repetitive transcranial magentic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 3 and 17 years at the time of enrollment
- Clinically diagnosed with Autism Spectrum Disorder (ASD), including assessment using the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
- Currently receiving outpatient care for ASD at the Department of Rehabilitation Medicine, CHA Bundang Medical Center
- The participant and their legal guardian have been fully informed of the study and have voluntarily provided written informed consent
Who cannot join
- Diagnosed with a major neurological condition other than ASD
- Epileptiform discharges detected on EEG screening requiring initiation or adjustment of antiepileptic medication
- Diagnosed with other psychiatric disorders, such as schizophrenia or major depressive disorder
- History of traumatic brain injury, brain tumor, or other significant brain conditions
- Deemed unsuitable for participation by the principal investigator
- Currently participating in another interventional clinical trial, or has participated in one within the past 30 days (excluding observational studies)
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- Any of the following contraindications to rTMS:
- Implanted electronic medical devices (e.g., pacemaker)
- Presence of metal implants in the skull
- Skin lesions at the stimulation site
- History of epilepsy
- Cervical spine pain or musculoskeletal disorders
- Pregnancy or currently breastfeeding
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This is a prospective, single-center, single-arm, investigator-initiated exploratory clinical trial aimed at evaluating the safety and exploring the efficacy of a medical electromagnetic stimulator delivering low-frequency repetitive transcranial magnetic stimulation (rTMS) in children and adolescents with Autism Spectrum Disorder (ASD). ASD is a neurodevelopmental disorder characterized by deficits in social interaction and communication and restricted, repetitive behaviors. Despite increasing prevalence, effective treatment options remain limited, and the demand for non-invasive, safe interventions continues to grow.
In this study, a total of 18 participants aged 3 to 17 years with a clinical diagnosis of ASD will be enrolled. Participants will receive rTMS using a medically approved electromagnetic stimulator applied to the dorsolateral prefrontal cortex (DLPFC) - five sessions per week for two consecutive weeks (total of 10 sessions). The first 5 sessions will target the left DLPFC, and the remaining 5 will target the right DLPFC. Each session includes 18 trains of 10-second stimulations at 1Hz frequency with 20-second inter-train intervals. The stimulation intensity is set at 90% of the resting motor threshold (rMT), determined individually using motor evoked potential testing.
Read more
The primary objective of this trial is to assess the safety of low-frequency rTMS in this population, with adverse events such as seizures, headaches, dizziness, and mood changes monitored throughout the trial. Vital signs will also be checked before and after each session. Secondary objectives include exploratory evaluation of rTMS effects on sensory processing (SP), social communication (SCQ), autism severity (K-CARS), behavioral symptoms (CBCL), brain activity changes (fNIRS), and electrophysiological responses (EEG), assessed at baseline, immediately after intervention, and at 1- and 3-month follow-ups.
All participants will undergo baseline assessments including EEG, SP, SCQ, K-CARS, CBCL, fNIRS, and vital signs. These measures will be repeated after the final rTMS session, and again at 1 and 3 months post-intervention. The trial will be conducted at CHA Bundang Medical Center, led by Principal Investigator Professor Minyoung Kim, Department of Rehabilitation Medicine.
This exploratory study is designed to provide preliminary evidence for the safety of low-frequency rTMS in ASD and to gather pilot data on its potential therapeutic effects, which may support future randomized controlled trials and clinical applications.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Repetitive transcranial magentic 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.
Repetitive transcranial magentic stimulationDevice
Low frequencey repetitive transcranial magentic stimulation
| Study group | Role | What they receive |
|---|---|---|
| Repetitive transcranial magnetic stimulation | Experimental | Repetitive transcranial magnetic stimulation Receives: Device: Repetitive transcranial magentic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Characteristics of Adverse Events Related to rTMS Treatment in Children and Adolescents with Autism Spectrum Disorder
This outcome measure assesses the safety of applying low-frequency repetitive transcranial magnetic stimulation (rTMS) using a medical electromagnetic stimulator in children and adolescents diagnosed with Autism Spectrum Disorder (ASD). All adverse events (AEs), including seizures, syncope, headaches, local pain, hearing problems, dizziness, mood disturbances, or other subjective discomforts, will be recorded during the study period. The severity and relationship of AEs to the intervention will be classified using standardized criteria (e.g., CTCAE v5.0). Vital signs will be monitored before and after each session to support safety evaluation.
Measured: From baseline (Day 1) through end of follow-up at 3 months after the final rTMS session (approximately 90 days)
Secondary outcomes (6)
Change in Sensory Profile (SP) Score
This outcome evaluates changes in sensory processing characteristics before and after the rTMS intervention using the Sensory Profile questionnaire. The aim is to explore whether low-frequency rTMS modulates sensory regulation in children and adolescents with ASD.
Measured: Baseline (Day 1), Post-intervention (Day 12), 1-month follow-up (Day ~30), 3-month follow-up (Day ~90)
Change in Social Communication Questionnaire (SCQ) Score
This measure assesses changes in social communication behaviors following rTMS intervention. The SCQ evaluates communication skills and social functioning relevant to autism characteristics.
Measured: Baseline (Day 1), Post-intervention (Day 12), 1-month follow-up (Day ~30), 3-month follow-up (Day ~90)
Change in Korean-Childhood Autism Rating Scale, 2nd Edition (K-CARS-2) Score
This outcome examines changes in autism severity by comparing K-CARS-2 scores across time points, investigating whether rTMS reduces core ASD symptoms.
Measured: Baseline (Day 1), Post-intervention (Day 12), 3-month follow-up (Day ~90)
Change in Child Behavior Checklist (CBCL) Score
This measure explores changes in emotional and behavioral functioning post-rTMS, using the CBCL, a parent-reported instrument capturing internalizing and externalizing problems.
Measured: Baseline (Day 1), Post-intervention (Day 12), 1-month follow-up (Day ~30), 3-month follow-up (Day ~90)
Change in Functional Near-Infrared Spectroscopy (fNIRS) Signals
This neuroimaging-based outcome assesses changes in cortical hemodynamic responses during cognitive and social tasks using fNIRS, particularly targeting the prefrontal cortex before and after rTMS.
Measured: Baseline (Day 1), 3-month follow-up (Day ~90)
Change in Electroencephalography (EEG) Patterns
Electroencephalography (EEG) will be recorded using a standard 10-20 electrode placement system. The power spectral density (PSD) will be computed for the following frequency bands:
- Delta (1-4 Hz)
- Theta (4-8 Hz)
- Alpha (8-13 Hz)
- Beta (13-30 Hz) Mean absolute and relative band power within these bands will be calculated for frontal, central, and parietal electrodes. Changes from baseline to post-intervention and follow-up periods will be analyzed to assess neuromodulatory effects of rTMS. Artifacts will be removed using independent component analysis (ICA).
Measured: Baseline (Day 1), 3-month follow-up (Day ~90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bundang CHA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MinYoung Kim, MD, PhD, Bundang CHA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982586
- Sponsor's protocol ID
- 2025-02-028
- Status last verified
- May 2025
- First submitted
- 11 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Single-Arm, Investigator-Initiated Exploratory Clinical Trial to Assess the Safety of Repetitive Transcranial Magnetic Stimulation for Children and Adolescents With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06982586
- Acronym / sponsor ID
- 2025-02-028
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Bundang CHA HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 May 2025 (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.
This is a prospective, single-center, single-arm, investigator-initiated exploratory clinical trial aimed at evaluating the safety and exploring the efficacy of a medical electromagnetic stimulator delivering low-frequency repetitive transcranial magnetic stimulation (rTMS) in children and adolescents with Autism Spectrum Disorder (ASD). ASD is a neurodevelopmental disorder characterized by deficits in social interaction and communication and restricted, repetitive behaviors. Despite increasing prevalence, effective treatment options remain limited, and the demand for non-invasive, safe interventions continues to grow.
In this study, a total of 18 participants aged 3 to 17 years with a clinical diagnosis of ASD will be enrolled. Participants will receive rTMS using a medically approved electromagnetic stimulator applied to the dorsolateral prefrontal cortex (DLPFC) - five sessions per week for two consecutive weeks (total of 10 sessions). The first 5 sessions will target the left DLPFC, and the remaining 5 will target the right DLPFC. Each session includes 18 trains of 10-second stimulations at 1Hz frequency with 20-second inter-train intervals. The stimulation intensity is set at 90% of the resting motor threshold (rMT), determined individually using motor evoked potential testing.
The primary objective of this trial is to assess the safety of low-frequency rTMS in this population, with adverse events such as seizures, headaches, dizziness, and mood changes monitored throughout the trial. Vital signs will also be checked before and after each session. Secondary objectives include exploratory evaluation of rTMS effects on sensory processing (SP), social communication (SCQ), autism severity (K-CARS), behavioral symptoms (CBCL), brain activity changes (fNIRS), and electrophysiological responses (EEG), assessed at baseline, immediately after intervention, and at 1- and 3-month follow-ups.
All participants will undergo baseline assessments including EEG, SP, SCQ, K-CARS, CBCL, fNIRS, and vital signs. These measures will be repeated after the final rTMS session, and again at 1 and 3 months post-intervention. The trial will be conducted at CHA Bundang Medical Center, led by Principal Investigator Professor Minyoung Kim, Department of Rehabilitation Medicine.
This exploratory study is designed to provide preliminary evidence for the safety of low-frequency rTMS in ASD and to gather pilot data on its potential therapeutic effects, which may support future randomized controlled trials and clinical applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Repetitive transcranial magnetic stimulation | Experimental | Device: Repetitive transcranial magentic stimulationRepetitive transcranial magnetic stimulation |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged between 3 and 17 years at the time of enrollment
- Clinically diagnosed with Autism Spectrum Disorder (ASD), including assessment using the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
- Currently receiving outpatient care for ASD at the Department of Rehabilitation Medicine, CHA Bundang Medical Center
- The participant and their legal guardian have been fully informed of the study and have voluntarily provided written informed consent
Key exclusion criteria (13 listed)
- Diagnosed with a major neurological condition other than ASD
- Epileptiform discharges detected on EEG screening requiring initiation or adjustment of antiepileptic medication
- Diagnosed with other psychiatric disorders, such as schizophrenia or major depressive disorder
- History of traumatic brain injury, brain tumor, or other significant brain conditions
- Deemed unsuitable for participation by the principal investigator
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 |
|---|---|---|
| Repetitive transcranial magentic stimulationLow frequencey repetitive transcranial magentic stimulation | Device | Repetitive transcranial magnetic stimulation |
Primary outcome
Incidence and Characteristics of Adverse Events Related to rTMS Treatment in Children and Adolescents with Autism Spectrum Disorder
Time frame: From baseline (Day 1) through end of follow-up at 3 months after the final rTMS session (approximately 90 days)
This outcome measure assesses the safety of applying low-frequency repetitive transcranial magnetic stimulation (rTMS) using a medical electromagnetic stimulator in children and adolescents diagnosed with Autism Spectrum Disorder (ASD). All adverse events (AEs), including seizures, syncope, headaches, local pain, hearing problems, dizziness, mood disturbances, or other subjective discomforts, will be recorded during the study period. The severity and relationship of AEs to the intervention will be classified using standardized criteria (e.g., CTCAE v5.0). Vital signs will be monitored before and after each session to support safety evaluation.
6 secondary outcomes
Change in Sensory Profile (SP) Score
Time frame: Baseline (Day 1), Post-intervention (Day 12), 1-month follow-up (Day ~30), 3-month follow-up (Day ~90)
Change in Social Communication Questionnaire (SCQ) Score
Time frame: Baseline (Day 1), Post-intervention (Day 12), 1-month follow-up (Day ~30), 3-month follow-up (Day ~90)
Change in Korean-Childhood Autism Rating Scale, 2nd Edition (K-CARS-2) Score
Time frame: Baseline (Day 1), Post-intervention (Day 12), 3-month follow-up (Day ~90)
Change in Child Behavior Checklist (CBCL) Score
Time frame: Baseline (Day 1), Post-intervention (Day 12), 1-month follow-up (Day ~30), 3-month follow-up (Day ~90)
Change in Functional Near-Infrared Spectroscopy (fNIRS) Signals
Time frame: Baseline (Day 1), 3-month follow-up (Day ~90)
Change in Electroencephalography (EEG) Patterns
Time frame: Baseline (Day 1), 3-month follow-up (Day ~90)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magentic stimulation in people with Autism Spectrum Disorder, run by Bundang CHA Hospital.
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 13 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: opening soon, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yubin KIM (82 031 780 6003 ext. 6003, a240285@chamc.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Characteristics of Adverse Events Related to rTMS Treatment in Children and Adolescents with Autism Spectrum Disorder (time frame: From baseline (Day 1) through end of follow-up at 3 months after the final rTMS session (approximately 90 days)). 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 21 May 2025.