Autism Spectrum DisorderNCT06142955
Transcranial Magnetic Stimulation (TMS) to Treat Depression in Autism Spectrum Disorder
A study testing MAGSTIM Rapid2 TMS system in people with Autism Spectrum Disorder, run by Yale University at 1 site in United States.
Trial summary
This study will assess clinical and behavioral measures along with electroencephalogram (EEG), event-related potentials (ERPS), and eye-tracking (ET) prior to and following a single intermittent Theta Burst Stimulation (iTBS) session to provide preliminary insight into the potential of TMS as an intervention for… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- MAGSTIM Rapid2 TMS system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2024to Feb 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals from Yale University and the surrounding community who are between the ages of 18 and 40 years old with or without a diagnosis of depression. Or individuals between the ages of 18 and 40 years old with a diagnosis of autism spectrum disorder, autistic disorder, PDD NOS, or Asperger syndrome with or without a diagnosis of depression.
- A depression score on the HDRS-17 of at least 20 will be used as a cut-off for depression.
- Participants are unmedicated or on stable medication treatment for at least two weeks.
- Willingness and ability to participate in an EEG and eye-tracking procedure.
- Provision of signed and dated informed consent.
Who cannot join
- Participants reporting significant head trauma or serious brain illness.
- Participants unable to provide signed informed consent.
- Participants with major psychiatric illness that would preclude completion of study measures. Participants with diagnosis of a psychotic or bipolar illness with be excluded.
- Participants with a history of serious medical illness, stroke, seizures, epileptiform EEG abnormalities, or family history of epilepsy.
- Participants taking prescription medications that may affect cognitive processes under study.
- Participants taking any medication that may increase their risk of seizures.
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- Participants who have taken alcohol or recreational drugs within the preceding 24 hours prior to the scheduled study visit as determined by the urine toxicology test.
- Participants with a history of substance or alcohol abuse or dependence in the past 6 months.
- Participants with a significant risk of suicide or a h/o suicide attempt in the last 6 months. Participants with active suicidal ideation will be excluded from the study.
- Females of known/suspected pregnancy or who test positive on a pregnancy test.
- Participants with a history of metalworking or injury by shrapnel or metallic objects.
- Participants with a history of prior TMS therapy or use of an investigational drug within 12 weeks of visit
- Participants with an IQ below 80 (as confirmed by the WASI, Wechsler Abbreviated Scale of Intelligence)
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
Yale Psychiatric Hospital
New Haven, Connecticut, 06520
About this study
Official title: Neuromodulation for Depression in Autism Spectrum Disorder
This study will assess clinical and behavioral measures along with electroencephalogram (EEG), event-related potentials (ERPS), and eye-tracking (ET) prior to and following a single intermittent Theta Burst Stimulation (iTBS) session to provide preliminary insight into the potential of TMS as an intervention for depression in individuals with Autism Spectrum Disorder (ASD).
Read the detailed description
Participants will complete two separate sessions, approximately one week apart, with each session including: 1) a baseline assessment of neuropsychological, cognitive and behavioral function, 2) neural and visual attentional social response (EEG/ET paradigm), 3) a single iTBS session or sham stimulation to the left DLPFC, and 4) poststimulation assessment of neural and visual attentional social response (EEG/ET paradigm). The order of active stimulation versus sham will be randomized such that half of the participants in each group get the sham stimulation during the first session and half will get active stimulation in the first session then crossover. EEG and eye-tracking will take approximately 60-minutes and will be collected pre-and-post TMS administration.
- Conditions
- Autism Spectrum Disorder
- Being tested
- MAGSTIM Rapid2 TMS system
- 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.
MAGSTIM Rapid2 TMS systemDevice
The device will administer TMS pulses in bursts at fixed intervals for a total of 600 pulses over 190 seconds after first assessing the participants motor threshold (MT). During the sham stimulation condition, the TMS coil will be tilted 90° tangential to the scalp during the administration so that the orientation is not biologically active and will not elicit a muscle contraction. This sham condition will look and sound just like real TMS.
| Study group | Role | What they receive |
|---|---|---|
| ASD with depression, iTBS then Sham | Experimental | Participants having ASD with depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received iTBS then sham approximately one week apart. Receives: Device: MAGSTIM Rapid2 TMS system |
| ASD with depression, Sham then iTBS | Experimental | Participants having ASD with depression will undergo EEG and ET with TMS prior to and following a single iTBS session.Participants first received sham then iTBS approximately one week apart. Receives: Device: MAGSTIM Rapid2 TMS system |
| ASD without depression, iTBS then Sham | Experimental | Participants having ASD without depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received iTBS then sham approximately one week apart. Receives: Device: MAGSTIM Rapid2 TMS system |
| ASD without depression, Sham then iTBS | Experimental | Participants having ASD without depression will undergo EEG and ET with TMS prior to and following a single iTBS session.Participants first received sham then iTBS approximately one week apart. Receives: Device: MAGSTIM Rapid2 TMS system |
| TD with depression, iTBS then Sham | Experimental | Participants that are TD with depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received iTBS then sham approximately one week apart. Receives: Device: MAGSTIM Rapid2 TMS system |
| TD with depression, Sham then iTBS | Experimental | Participants that are TD with depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received sham then iTBS approximately one week apart. Receives: Device: MAGSTIM Rapid2 TMS system |
| TD without depression, iTBS then Sham | Experimental | Participants that are TD without depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received iTBS then sham approximately one week apart. Receives: Device: MAGSTIM Rapid2 TMS system |
| TD without depression, Sham then iTBS | Experimental | Participants that are TD without depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received sham then iTBS approximately one week apart. Receives: Device: MAGSTIM Rapid2 TMS system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Electroencephalogram (EEG) brain responses to sad faces
As measured by amplitude and latency of event related potentials (ERP) (the right lateralized P100, P200 and amplitude of N170) to sad faces. EEG: an electrophysiological assay that measures brain activity from the scalp.
Measured: baseline and up to week 2
Change in eye tracking (ET) to sad faces
ET will measure participant attention to the screen and be used to ensure that participants are looking at the stimulus display screen during the course of the experimental paradigms. Change in Proportion of fixation (POF) to the eye region in sad faces as measured by ET.
Measured: baseline and up to week 2
Change in Auditory Steady State Response (ASSR)
ASSR measures an electrophysiological response in the human cortex after presenting stimulation consisting of pure tones at certain frequencies. For assessment of ASSRs, subjects will sit in an acoustically shielded booth in front of a computer monitor with eyes open, while passively listening to click trains presented through Etymotic insert ER-1 earphones (Etymotic Research, Elk Grove Village, IL). Stimuli will consist of standard, unattended (nontarget) auditory click trains from a three-stimulus oddball tasks. The output is thus measured in the EEG recording which is analyzed in the frequency domain. Measures of inter-trial coherence (ITC) are used to determine neural synchrony through the ASSR task, by quantifying the degree of phase consistency across trials. ASSR Power is the magnitude of the brain's voltage response to a stimulus and the consistency across trials of the time course of this time-locked response.
Measured: baseline and up to week 2
Secondary outcomes (4)
Change in neural processing on EEG to sad faces
The latency of the right lateralized N170, an ERP component that reflects the neural processing of faces, familiar objects, or words, to sad faces.
Measured: baseline and up to week 2
Change in ET to different emotionally valenced faces
The amplitude and latency of the right lateralized N170 as measured from eye-fixation related potentials (EFRP) when participants are viewing different emotionally valenced faces.
Measured: baseline and up to week 2
Change in ET to neutral faces and non-social stimuli
ET will measure participant attention to the screen and be used to ensure that participants are looking at the stimulus display screen during the course of the experimental paradigms. Change in proportion of fixation to eyes in neutral faces and non-social stimuli (i.e., houses).
Measured: baseline and up to week 2
Change in Frith Happé Animations Task
The latency to look to the eye-region of faces relative to image onset, measured in milliseconds (ms) for sad and neutral faces and triangle pursuit duration in an anthropomorphic animated triangles test.
Measured: baseline and up to week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start30 Apr 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Typically developing (TD) controls and ASD participants with and without depression will receive both active and sham TMS in a randomized crossover assignment involving two study sessions.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Child Adolescent Psychiatry.
- Responsible party
- Sponsor
- Investigators
- Sherab Tsheringla, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142955
- Sponsor's protocol ID
- 2000035486
- Other IDs
- 000
- Status last verified
- Jul 2026
- First submitted
- 15 Nov 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation for Depression in Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06142955
- Acronym / sponsor ID
- 2000035486
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- American Academy of Child Adolescent Psychiatry.
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 22 Nov 2023 (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 study will assess clinical and behavioral measures along with electroencephalogram (EEG), event-related potentials (ERPS), and eye-tracking (ET) prior to and following a single intermittent Theta Burst Stimulation (iTBS) session to provide preliminary insight into the potential of TMS as an intervention for depression in individuals with Autism Spectrum Disorder (ASD).
Detailed description
Participants will complete two separate sessions, approximately one week apart, with each session including: 1) a baseline assessment of neuropsychological, cognitive and behavioral function, 2) neural and visual attentional social response (EEG/ET paradigm), 3) a single iTBS session or sham stimulation to the left DLPFC, and 4) poststimulation assessment of neural and visual attentional social response (EEG/ET paradigm). The order of active stimulation versus sham will be randomized such that half of the participants in each group get the sham stimulation during the first session and half will get active stimulation in the first session then crossover. EEG and eye-tracking will take approximately 60-minutes and will be collected pre-and-post TMS administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 8
- Model description
- Typically developing (TD) controls and ASD participants with and without depression will receive both active and sham TMS in a randomized crossover assignment involving two study sessions.
| Arm | Type | Receives |
|---|---|---|
| ASD with depression, iTBS then Sham | Experimental | Device: MAGSTIM Rapid2 TMS systemParticipants having ASD with depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received iTBS then sham approximately one week apart. |
| ASD with depression, Sham then iTBS | Experimental | Device: MAGSTIM Rapid2 TMS systemParticipants having ASD with depression will undergo EEG and ET with TMS prior to and following a single iTBS session.Participants first received sham then iTBS approximately one week apart. |
| ASD without depression, iTBS then Sham | Experimental | Device: MAGSTIM Rapid2 TMS systemParticipants having ASD without depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received iTBS then sham approximately one week apart. |
| ASD without depression, Sham then iTBS | Experimental | Device: MAGSTIM Rapid2 TMS systemParticipants having ASD without depression will undergo EEG and ET with TMS prior to and following a single iTBS session.Participants first received sham then iTBS approximately one week apart. |
| TD with depression, iTBS then Sham | Experimental | Device: MAGSTIM Rapid2 TMS systemParticipants that are TD with depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received iTBS then sham approximately one week apart. |
| TD with depression, Sham then iTBS | Experimental | Device: MAGSTIM Rapid2 TMS systemParticipants that are TD with depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received sham then iTBS approximately one week apart. |
| TD without depression, iTBS then Sham | Experimental | Device: MAGSTIM Rapid2 TMS systemParticipants that are TD without depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received iTBS then sham approximately one week apart. |
| TD without depression, Sham then iTBS | Experimental | Device: MAGSTIM Rapid2 TMS systemParticipants that are TD without depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received sham then iTBS approximately one week apart. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Individuals from Yale University and the surrounding community who are between the ages of 18 and 40 years old with or without a diagnosis of depression. Or individuals between the ages of 18 and 40 years old with a diagnosis of autism spectrum disorder, autistic disorder, PDD NOS, or Asperger syndrome with or without a diagnosis of depression.
- A depression score on the HDRS-17 of at least 20 will be used as a cut-off for depression.
- Participants are unmedicated or on stable medication treatment for at least two weeks.
- Willingness and ability to participate in an EEG and eye-tracking procedure.
- Provision of signed and dated informed consent.
Key exclusion criteria (13 listed)
- Participants reporting significant head trauma or serious brain illness.
- Participants unable to provide signed informed consent.
- Participants with major psychiatric illness that would preclude completion of study measures. Participants with diagnosis of a psychotic or bipolar illness with be excluded.
- Participants with a history of serious medical illness, stroke, seizures, epileptiform EEG abnormalities, or family history of epilepsy.
- Participants taking prescription medications that may affect cognitive processes under study.
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 |
|---|---|---|
| MAGSTIM Rapid2 TMS systemThe device will administer TMS pulses in bursts at fixed intervals for a total of 600 pulses over 190 seconds after first assessing the participants motor threshold (MT). During the sham stimulation condition, the TMS coil will be tilted 90° tangential to the scalp during the administration so that the orientation is not biologically active and will not elicit a muscle contraction. This sham condition will look and sound just like real TMS. | Device | ASD with depression, Sham then iTBS, ASD with depression, iTBS then Sham, ASD without depression, Sham then iTBS, ASD without depression, iTBS then Sham, TD with depression, Sham then iTBS, TD with depression, iTBS then Sham, TD without depression, Sham then iTBS, TD without depression, iTBS then Sham |
Primary outcome
Change in Electroencephalogram (EEG) brain responses to sad faces
Time frame: baseline and up to week 2
As measured by amplitude and latency of event related potentials (ERP) (the right lateralized P100, P200 and amplitude of N170) to sad faces. EEG: an electrophysiological assay that measures brain activity from the scalp.
Change in eye tracking (ET) to sad faces
Time frame: baseline and up to week 2
ET will measure participant attention to the screen and be used to ensure that participants are looking at the stimulus display screen during the course of the experimental paradigms. Change in Proportion of fixation (POF) to the eye region in sad faces as measured by ET.
Change in Auditory Steady State Response (ASSR)
Time frame: baseline and up to week 2
ASSR measures an electrophysiological response in the human cortex after presenting stimulation consisting of pure tones at certain frequencies. For assessment of ASSRs, subjects will sit in an acoustically shielded booth in front of a computer monitor with eyes open, while passively listening to click trains presented through Etymotic insert ER-1 earphones (Etymotic Research, Elk Grove Village, IL). Stimuli will consist of standard, unattended (nontarget) auditory click trains from a three-stimulus oddball tasks. The output is thus measured in the EEG recording which is analyzed in the frequency domain. Measures of inter-trial coherence (ITC) are used to determine neural synchrony through the ASSR task, by quantifying the degree of phase consistency across trials. ASSR Power is the magnitude of the brain's voltage response to a stimulus and the consistency across trials of the time course of this time-locked response.
4 secondary outcomes
Change in neural processing on EEG to sad faces
Time frame: baseline and up to week 2
Change in ET to different emotionally valenced faces
Time frame: baseline and up to week 2
Change in ET to neutral faces and non-social stimuli
Time frame: baseline and up to week 2
Change in Frith Happé Animations Task
Time frame: baseline and up to week 2
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 16 Jul 2026.
- 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.
Sherab Tsheringla, 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 MAGSTIM Rapid2 TMS system 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 5 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: looking for participants now, as of the sponsor's last update on 16 Jul 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 Sherab Tsheringla, MD (2032158046, sherab.tsheringla@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Electroencephalogram (EEG) brain responses to sad faces (time frame: baseline and up to week 2). The study lists 3 primary outcomes in all. 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 16 Jul 2026.