Autism Spectrum DisorderNCT06214065
Modulating Temporoparietal Junction Mentalizing-Related Activity in Autism Spectrum Disorder (ASD) Using Transcranial Magnetic Stimulation (TMS)
A study testing fMRI and rTMS in people with Autism Spectrum Disorder, run by Yale University at 1 site in United States.
Trial summary
The goal of this observational study is to test the modulation effect of different transcranial magnetic stimulation (TMS) on the neural network supporting our ability to create mental representations of others (also known as mentalizing) in young adults with autism. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- fMRI and rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2024to Oct 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Estimated full-scale IQ>80
- Right handed
- Fluent in English
- Individual can cooperate with all study's procedures
- No history of neurological disorder (e.g. epilepsy) or neurosurgery
- No major medical condition (e.g. cancer, heart failure)
Show all 15Show fewer
- No history of significant head injury
- No primary relatives with history of any neurological disorder with a potentially hereditary basis, including epilepsy or MS
- No current use of medications with psychotropic (e.g., benzodiazepines) or anti- or pro-convulsants
- No current substance use (determined by urine screen and breathalyzer in all visits)
- Negative urine pregnancy (women) test at time of MRI scans
- No MR contra-indications (e.g. in-body metal implant, severe claustrophobia)
- No previous participation in our lab in a study including the Domino fMRI task
- For ASD: Stable medication treatment 4 weeks prior to study enrollment
- For Control Group: No current or history of psychiatric disorders, other than simple phobia, and/or primary relatives with ASD
Who cannot join
- -
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
Olin Neuropsychiatry Research Center (ONRC)
Hartford, Connecticut, 06106
About this study
Official title: Modulating Temporoparietal Junction Mentalizing-Related Activity in Autism Spectrum Disorder Using Transcranial Magnetic Stimulation
The goal of this observational study is to test the modulation effect of different transcranial magnetic stimulation (TMS) on the neural network supporting our ability to create mental representations of others (also known as mentalizing) in young adults with autism. The main question it aims to answers is can stimulation of the right temporoparietal junction can change brain activity related to mentalizing during social interaction in the stimulation area and other brain areas connected to it. Researchers will compare results to a group of individuals without autism to see if the patterns of neural activity change are similar between the groups.
Participants will undergo assessment of their clinical traits and social skills and baseline MRI scan. They will attend three additional visits that include TMS session and functional MRI scans before and right after TMS.
Read the detailed description
All participants will be scheduled for four study sessions that include a baseline and three subsequent sessions that will each include two functional magnetic resonance imaging (fMRI) scans, one pre and one post an rTMS session.
During each fMRI scan, participants will be engaged in intersocial, competitive Domino task that involves mentalizing. rTMS manipulation, administered in a double-blind, counterbalanced fashion, includes one session each of excitatory (intermittent theta-burst stimulation, iTBS), inhibitory (continuous TBS, cTBS), and sham sequences. The rTMS will be guided with individualized electric-field modeling calculated from a structural MRI scan collected on the baseline session. This robust design is necessary to identify the optimal rTMS sequence to engage the right TPJ and the mentalizing network in ASD because firm conclusions about how best to modulate this network cannot be drawn from the few known published reports.
Investigators hypothesize that iTBS will result in increased, while cTBS in decreased MTR neural activity in the mentalizing network, with this being more pronounced in ASD, and sham resulting in no change. Understanding this mechanism will be the first and crucial step in validating rTMS of the right TPJ as a viable neural target to modulate neural circuit, and subsequently to modulate social-communication skills in ASD in future clinical studies. The significance of such a line of research should be considered in the context of the high prevalence of ASD and the dire need of developing effective interventions, especially for adults.
The three rTMS sessions will be compared within-subject and between-groups.
- Conditions
- Autism Spectrum Disorder
- Being tested
- fMRI, rTMS
- Keywords
- Transcranial Magnetic 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.
fMRIDiagnostic test
fMRI will be performed pre- and post-rTMS
rTMSDevice
TMS procedures are scheduled during study sessions 2-4 between the two MRI scans on those days. Because rTMS induces neural changes that last about 1 hour, rTMS will be applied immediately before the second MRI scan on each day. Prior to the TMS visits, target coordinates and orientation vectors will be generated from the MRI data and the e-field models and loaded into Localite along with the participant's reconstructed T1 image. During the visits, the participant's head will be co-registered to the T1 using fiducial points at the Nasion and Tragi. TMS pulses will be delivered, using the Localite software to target and track the optimal orientation calculated with e-field modeling.
| Study group | Role | What they receive |
|---|---|---|
| ASD: excitatory, then inhibitory, then sham rTMS | Experimental | Participants in this group will undergo fMRI pre- and post- rTMS. Each will receive an excitatory, inhibitory and sham rTMS to the right temporoparietal junction (TPJ) on mentalizing task-related (MTR) activity over 4 study visits. Receives: Diagnostic Test: fMRI; Device: rTMS |
| Typically Developing (TD): excitatory, then inhibitory, then sham rTMS | Experimental | Participants in this group will undergo fMRI pre- and post- rTMS. Each will receive an excitatory, inhibitory and sham rTMS to the right temporoparietal junction (TPJ) on mentalizing task-related (MTR) activity over 4 study visits. Receives: Diagnostic Test: fMRI; Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mentalizing Task Related (MTR) neural activity in the mentalizing network
Change in MTR activity in six brain regions, from fMRI scans will be measured pre- to post-rTMS.
Measured: during each fMRI, up to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start3 Apr 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 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.
- More trials run by Yale 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Vaughn Steele, MD, Principal investigator, Yale UniversityMichal Assaf, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214065
- Sponsor's protocol ID
- HHC-2023-0203
- Other IDs
- R01MH132044, Assaf 121223, 2000039667
- Status last verified
- Mar 2026
- First submitted
- 9 Jan 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All investigators are aware of and agree to abide by the principles for sharing research resources, as described by NIH in "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Programs." Specifically, all data collected in this study, including demographic information, psychiatric, symptom, cognitive and social assessments as well as MRI imaging data, will be shared with the scientific community through the National Institute of Mental Health Data Archive (NDA).
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Temporoparietal Junction Mentalizing-Related Activity in Autism Spectrum Disorder Using Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT06214065
- Acronym / sponsor ID
- HHC-2023-0203
- Conditions
- Autism Spectrum Disorder
- Keywords
- Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 Jan 2024 (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 goal of this observational study is to test the modulation effect of different transcranial magnetic stimulation (TMS) on the neural network supporting our ability to create mental representations of others (also known as mentalizing) in young adults with autism. The main question it aims to answers is can stimulation of the right temporoparietal junction can change brain activity related to mentalizing during social interaction in the stimulation area and other brain areas connected to it. Researchers will compare results to a group of individuals without autism to see if the patterns of neural activity change are similar between the groups.
Participants will undergo assessment of their clinical traits and social skills and baseline MRI scan. They will attend three additional visits that include TMS session and functional MRI scans before and right after TMS.
Detailed description
All participants will be scheduled for four study sessions that include a baseline and three subsequent sessions that will each include two functional magnetic resonance imaging (fMRI) scans, one pre and one post an rTMS session.
During each fMRI scan, participants will be engaged in intersocial, competitive Domino task that involves mentalizing. rTMS manipulation, administered in a double-blind, counterbalanced fashion, includes one session each of excitatory (intermittent theta-burst stimulation, iTBS), inhibitory (continuous TBS, cTBS), and sham sequences. The rTMS will be guided with individualized electric-field modeling calculated from a structural MRI scan collected on the baseline session. This robust design is necessary to identify the optimal rTMS sequence to engage the right TPJ and the mentalizing network in ASD because firm conclusions about how best to modulate this network cannot be drawn from the few known published reports.
Investigators hypothesize that iTBS will result in increased, while cTBS in decreased MTR neural activity in the mentalizing network, with this being more pronounced in ASD, and sham resulting in no change. Understanding this mechanism will be the first and crucial step in validating rTMS of the right TPJ as a viable neural target to modulate neural circuit, and subsequently to modulate social-communication skills in ASD in future clinical studies. The significance of such a line of research should be considered in the context of the high prevalence of ASD and the dire need of developing effective interventions, especially for adults.
The three rTMS sessions will be compared within-subject and between-groups.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD: excitatory, then inhibitory, then sham rTMS | Experimental | Diagnostic Test: fMRI, Device: rTMSParticipants in this group will undergo fMRI pre- and post- rTMS. Each will receive an excitatory, inhibitory and sham rTMS to the right temporoparietal junction (TPJ) on mentalizing task-related (MTR) activity over 4 study visits. |
| Typically Developing (TD): excitatory, then inhibitory, then sham rTMS | Experimental | Diagnostic Test: fMRI, Device: rTMSParticipants in this group will undergo fMRI pre- and post- rTMS. Each will receive an excitatory, inhibitory and sham rTMS to the right temporoparietal junction (TPJ) on mentalizing task-related (MTR) activity over 4 study visits. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Estimated full-scale IQ>80
- Right handed
- Fluent in English
- Individual can cooperate with all study's procedures
- No history of neurological disorder (e.g. epilepsy) or neurosurgery
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| fMRIfMRI will be performed pre- and post-rTMS | Diagnostic test | ASD: excitatory, then inhibitory, then sham rTMS, Typically Developing (TD): excitatory, then inhibitory, then sham rTMS |
| rTMSTMS procedures are scheduled during study sessions 2-4 between the two MRI scans on those days. Because rTMS induces neural changes that last about 1 hour, rTMS will be applied immediately before the second MRI scan on each day. Prior to the TMS visits, target coordinates and orientation vectors will be generated from the MRI data and the e-field models and loaded into Localite along with the participant's reconstructed T1 image. During the visits, the participant's head will be co-registered to the T1 using fiducial points at the Nasion and Tragi. TMS pulses will be delivered, using the Localite software to target and track the optimal orientation calculated with e-field modeling. | Device | ASD: excitatory, then inhibitory, then sham rTMS, Typically Developing (TD): excitatory, then inhibitory, then sham rTMS |
Primary outcome
Mentalizing Task Related (MTR) neural activity in the mentalizing network
Time frame: during each fMRI, up to 5 hours
Change in MTR activity in six brain regions, from fMRI scans will be measured pre- to post-rTMS.
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 27 Mar 2026.
- Individual participant dataSharing planned: Yes. All investigators are aware of and agree to abide by the principles for sharing research resources, as described by NIH in "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Programs." Specifically, all data collected in this study, including demographic information, psychiatric, symptom, cognitive and social assessments as well as MRI imaging data, will be shared with the scientific community through the National Institute of Mental Health Data Archive (NDA).
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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.
Vaughn Steele, MD principal investigator
Yale University
Michal Assaf, MD principal investigator
Yale 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 fMRI and rTMS in people with Autism Spectrum Disorder, run by Yale 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 15 inclusion and 1 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 27 Mar 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 Michal Assaf, MD (860-545-7792, michal.assaf@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mentalizing Task Related (MTR) neural activity in the mentalizing network (time frame: during each fMRI, up to 5 hours). 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 27 Mar 2026.