Transcranial Magnetic Stimulation (TMS) to Treat Depression in Autism Spectrum Disorder

July 14, 2026 updated by: Yale University

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale Psychiatric Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ASD with depression, iTBS then Sham
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.
Device: MAGSTIM Rapid2 TMS system
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.
Experimental: ASD with depression, Sham then iTBS
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.
Device: MAGSTIM Rapid2 TMS system
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.
Experimental: ASD without depression, iTBS then Sham
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.
Device: MAGSTIM Rapid2 TMS system
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.
Experimental: ASD without depression, Sham then iTBS
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.
Device: MAGSTIM Rapid2 TMS system
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.
Experimental: TD with depression, iTBS then Sham
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.
Device: MAGSTIM Rapid2 TMS system
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.
Experimental: TD with depression, Sham then iTBS
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.
Device: MAGSTIM Rapid2 TMS system
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.
Experimental: TD without depression, iTBS then Sham
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.
Device: MAGSTIM Rapid2 TMS system
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.
Experimental: TD without depression, Sham then iTBS
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.
Device: MAGSTIM Rapid2 TMS system
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline and up to week 2
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.
baseline and up to week 2
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.
baseline and up to week 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in neural processing on EEG to sad faces
Time Frame: baseline and up to week 2
The latency of the right lateralized N170, an ERP component that reflects the neural processing of faces, familiar objects, or words, to sad faces.
baseline and up to week 2
Change in ET to different emotionally valenced faces
Time Frame: baseline and up to week 2
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.
baseline and up to week 2
Change in ET to neutral faces and non-social stimuli
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 to eyes in neutral faces and non-social stimuli (i.e., houses).
baseline and up to week 2
Change in Frith Happé Animations Task
Time Frame: baseline and up to week 2
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.
baseline and up to week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Academy of Child Adolescent Psychiatry.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sherab Tsheringla, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000035486
  • 000 (Other Identifier: CTGTY)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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