Autism Spectrum DisorderTMS for ASDNCT04532424
Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD
A study testing Transcranial magnetic stimulation in people with Autism Spectrum Disorder and Autism, run by Stanford University at 1 site in United States.
Trial summary
Investigating the efficacy of a form of TMS called theta-burst stimulation for restricted and repetitive behavior in ASD. Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Autism Spectrum Disorder, Autism, Asperger Syndrome
- What is being tested?
- Transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 1 Dec 2029
- 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 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of Autism Spectrum Disorder (ASD)
- Meet criteria for Autism Spectrum Disorder (ASD) on clinical assessments (ADOS-2 or CARS if conducted remotely \& ADI-R)
- Aged between 12-45 years old
- Have a reliable informant who can complete relevant questionnaires
- Have DARB scores which indicate high levels (50% or above) of RRB on one of the following domains: Insistence on Sameness, Obsessive Compulsive Behaviors, and Unusual Interests
Who cannot join
- Any contraindications for TMS e.g. history of seizures other than clear substance-induced/fever-induced seizures with neurologist note or normal clean EEG and no seizure in at least 12 months prior to enrollment.
- Pregnancy.
- Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
- Active substance use (<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines.
- Showing symptoms of withdrawal from alcohol or benzodiazepines.
- DSM-5 diagnosis of bipolar disorder or a psychotic disorder e.g. schizophrenia.
Show all 12Show fewer
- Significant sensory impairments such as blindness or deafness.
- Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation).
- Not willing to cooperate with the TMS procedures.
- Currently taking Clozapine or another medication that the PI determines increases the risk of TMS or may disrupt the efficacy.
- A motor threshold that is too high to allow safe/tolerable treatment.
- Conditions that increase the risk for COVID-19 (in accordance with university guidelines).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305-5719
Ryan Villacrucis, (650) 736-1235, autismdd@stanford.edu
About this study
Investigating the efficacy of a form of TMS called theta-burst stimulation for restricted and repetitive behavior in ASD.
- Conditions
- Autism Spectrum Disorder, Autism, Asperger Syndrome
- Being tested
- Transcranial magnetic stimulation
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationDevice
Non-invasive brain stimulation technique that is FDA-approved for the treatment of refractory depression, OCD and migraine.
| Study group | Role | What they receive |
|---|---|---|
| Targeting insistence on sameness | Experimental | Not described Receives: Device: Transcranial magnetic stimulation |
| Targeting stereotyped motor behaviors | Experimental | Not described Receives: Device: Transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repetitive Behavior Scale-Revised (RBS-R)
44-item parent-report questionnaire to measure restricted and repetitive behavior in ASD. We predict that each TMS target will selectively reduce the subscale being targeted.
Measured: Up to one month post-treatment
Secondary outcomes (1)
Set-shifting performance (Dimensional Change Card Sort Test score)
The Dimensional Change Card Sort Test one of the cognitive measures from the NIH toolbox. These measures are administered on an iPad. The test takes 4 minutes to complete.
Measured: Baseline & immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start4 Jan 2021
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
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 Stanford 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of 2 groups based on the presentation of restricted and repetitive behavior.
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Hardan, Stanford University
- Investigators
- Antonio Y. Hardan, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532424
- Sponsor's protocol ID
- IRB-57738
- Acronym
- TMS for ASD
- Status last verified
- Nov 2026
- First submitted
- 21 Aug 2020
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Barahona-Correa JB, Velosa A, Chainho A, Lopes R, Oliveira-Maia AJ. Repetitive Transcranial Magnetic Stimulation for Treatment of Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. Front Integr Neurosci. 2018 Jul 9;12:27. doi: 10.3389/fnint.2018.00027. eCollection 2018.
PubMed 30038561Oberman LM, Rotenberg A, Pascual-Leone A. Use of transcranial magnetic stimulation in autism spectrum disorders. J Autism Dev Disord. 2015 Feb;45(2):524-36. doi: 10.1007/s10803-013-1960-2.
PubMed 24127165
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD
- ClinicalTrials.gov ID
- NCT04532424
- Acronym / sponsor ID
- TMS for ASD / IRB-57738
- Conditions
- Autism Spectrum Disorder, Autism, Asperger Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 31 Aug 2020 (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.
Investigating the efficacy of a form of TMS called theta-burst stimulation for restricted and repetitive behavior in ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to one of 2 groups based on the presentation of restricted and repetitive behavior.
| Arm | Type | Receives |
|---|---|---|
| Targeting insistence on sameness | Experimental | Device: Transcranial magnetic stimulation |
| Targeting stereotyped motor behaviors | Experimental | Device: Transcranial magnetic stimulation |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosis of Autism Spectrum Disorder (ASD)
- Meet criteria for Autism Spectrum Disorder (ASD) on clinical assessments (ADOS-2 or CARS if conducted remotely \& ADI-R)
- Aged between 12-45 years old
- Have a reliable informant who can complete relevant questionnaires
- Have DARB scores which indicate high levels (50% or above) of RRB on one of the following domains: Insistence on Sameness, Obsessive Compulsive Behaviors, and Unusual Interests
Key exclusion criteria (12 listed)
- Any contraindications for TMS e.g. history of seizures other than clear substance-induced/fever-induced seizures with neurologist note or normal clean EEG and no seizure in at least 12 months prior to enrollment.
- Pregnancy.
- Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
- Active substance use (<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines.
- Showing symptoms of withdrawal from alcohol or benzodiazepines.
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 magnetic stimulationNon-invasive brain stimulation technique that is FDA-approved for the treatment of refractory depression, OCD and migraine. | Device | Targeting insistence on sameness, Targeting stereotyped motor behaviors |
Primary outcome
Repetitive Behavior Scale-Revised (RBS-R)
Time frame: Up to one month post-treatment
44-item parent-report questionnaire to measure restricted and repetitive behavior in ASD. We predict that each TMS target will selectively reduce the subscale being targeted.
1 secondary outcome
Set-shifting performance (Dimensional Change Card Sort Test score)
Time frame: Baseline & immediately after treatment
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 5 Nov 2026.
- Background: PubMed 30038561Barahona-Correa JB, Velosa A, Chainho A, Lopes R, Oliveira-Maia AJ. Repetitive Transcranial Magnetic Stimulation for Treatment of Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. Front Integr Neurosci. 2018 Jul 9;12:27. doi: 10.3389/fnint.2018.00027. eCollection 2018.
- Background: PubMed 24127165Oberman LM, Rotenberg A, Pascual-Leone A. Use of transcranial magnetic stimulation in autism spectrum disorders. J Autism Dev Disord. 2015 Feb;45(2):524-36. doi: 10.1007/s10803-013-1960-2.
- 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.
Antonio Y. Hardan, MD principal investigator
Stanford 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 magnetic stimulation in people with Autism Spectrum Disorder and Autism, run by Stanford University at 1 site in United States.
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 12 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: looking for participants now, as of the sponsor's last update on 5 Nov 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 United States. 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?
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 Briana Hernandez ((650) 736-1235, autismdd@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repetitive Behavior Scale-Revised (RBS-R) (time frame: Up to one month post-treatment). 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 NCT04532424, 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 5 Nov 2026.