Recruiting

TMS

Sponsor:

Yale University

Code:

NCT06142955

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

MAGSTIM Rapid2 TMS system

Study Details

Brief 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 depression in individuals with Autism Spectrum Disorder (ASD).

Conditions

Autism Spectrum Disorder

Study ID

NCT06142955

Start date

Apr 30, 2024

Status verified date

Jul, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

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.

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.

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.

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.

Interventions

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.

Primary outcome measure

  • Change in Electroencephalogram (EEG) brain responses to sad faces [ Time Frame: baseline and up to week 2 ]
  • Change in eye tracking (ET) to sad faces [ Time Frame: baseline and up to week 2 ]
  • Change in Auditory Steady State Response (ASSR) [ Time Frame: baseline and up to week 2 ]

Central Contacts and Locations

Central contacts

Sherab Tsheringla, MD

2032158046sherab.tsheringla@yale.edu

Locations

Yale Psychiatric Hospital

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Yale University on 2026-07-16.