Using Transcranial Magnetic Stimulation to Treat Depression in Autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effects of intermittent Theta Burst Stimulation (iTBS) using Transcranial Magnetic Stimulation (TMS) on individuals with Autism Spectrum Disorder (ASD) who also experience depression. Participants will undergo two sessions, one week apart, where they will receive either active TMS or sham stimulation, with assessments of cognitive and behavioral functions, as well as neural responses through EEG and eye-tracking. The study aims to provide preliminary insights into the efficacy of TMS as a treatment for depression in this population.

Why it matters

Who can join: the full rules

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)

Where it's running

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

Study contacts

• Principal investigator: Sherab Tsheringla, MD — Yale University
• Study coordinator: Sherab Tsheringla, MD
• Email: sherab.tsheringla@yale.edu
• Phone: 2032158046

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.