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Search / Trial NCT06142955

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

Launched by YALE UNIVERSITY · Nov 15, 2023

Trial Information

Current as of July 04, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a treatment called Transcranial Magnetic Stimulation (TMS) to help reduce depression in individuals with Autism Spectrum Disorder (ASD). The study is looking at how TMS affects brain activity and behavior before and after a session of a specific type of TMS called intermittent Theta Burst Stimulation (iTBS). This research aims to provide early insights into whether TMS could be a beneficial intervention for those experiencing depression alongside ASD.

To participate, individuals must be between 18 and 40 years old and either have a diagnosis of ASD or have high levels of depression. Participants should either not be on medication or have been on stable medication for at least two weeks. The study will involve some tests, such as brain activity monitoring using EEG and eye-tracking, which are non-invasive and safe procedures. It's important to note that certain individuals, such as those with significant brain injury, serious psychiatric illnesses, or a history of substance abuse, may not be eligible for this study. If you or someone you know might be interested, feel free to reach out to see if you meet the criteria!

Gender

ALL

Eligibility criteria

  • 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)

About Yale University

Yale University, a prestigious Ivy League institution located in New Haven, Connecticut, is renowned for its commitment to advancing medical research and clinical innovation. With a rich history of academic excellence and a robust infrastructure for scientific inquiry, Yale serves as a leading sponsor for clinical trials aimed at improving patient care and developing new therapeutic approaches. The university's multidisciplinary teams of researchers and clinicians collaborate to conduct rigorous and ethical studies, leveraging cutting-edge technologies and methodologies to address critical health challenges. Through its dedication to fostering an environment of inquiry and discovery, Yale University plays a pivotal role in translating research findings into clinical practice, ultimately enhancing health outcomes for diverse populations.

Locations

New Haven, Connecticut, United States

Patients applied

0 patients applied

Trial Officials

Sherab Tsheringla, MD

Principal Investigator

Yale University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported