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Behavioural Intervention

TMS for Depression in Autism Spectrum Disorder

N/A

Recruiting

Led By Sherab Tsheringla, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and up to week 2

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the use of TMS to treat depression in people with ASD by analyzing brain activity, behavior, and eye movement.

Who is the study for?

This trial is for individuals aged 18-40 with autism spectrum disorder, including those diagnosed with autistic disorder, PDD NOS, or Asperger syndrome. Participants may have depression (with a score of at least 20 on the HDRS-17) and must be either unmedicated or on stable medication for two weeks. They should be able to undergo EEG and eye-tracking procedures and provide informed consent.

What is being tested?

The study is testing the effects of a single session using the MAGSTIM Rapid2 TMS system, specifically intermittent Theta Burst Stimulation (iTBS), to see if it can help alleviate symptoms of depression in people with Autism Spectrum Disorder. It includes assessments like clinical measures, EEGs, event-related potentials (ERPs), and eye-tracking both before and after treatment.

What are the potential side effects?

While not explicitly listed in your provided information, common side effects from TMS treatments can include headache, scalp discomfort during stimulation sessions, lightheadedness, tingling or spasms in facial muscles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and up to week 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and up to week 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and up to week 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Auditory Steady State Response (ASSR)

Change in Electroencephalogram (EEG) brain responses to sad faces

Change in eye tracking (ET) to sad faces

Secondary study objectives

Change in ET to different emotionally valenced faces

Change in ET to neutral faces and non-social stimuli

Change in Frith Happé Animations Task

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups

Experimental Treatment

Group I: TD without depression, iTBS then ShamExperimental Treatment1 Intervention

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.

Group II: TD without depression, Sham then iTBSExperimental Treatment1 Intervention

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.

Group III: TD with depression, iTBS then ShamExperimental Treatment1 Intervention

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.

Group IV: TD with depression, Sham then iTBSExperimental Treatment1 Intervention

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.

Group V: ASD without depression, iTBS then ShamExperimental Treatment1 Intervention

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.

Group VI: ASD without depression, Sham then iTBSExperimental Treatment1 Intervention

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.

Group VII: ASD with depression, iTBS then ShamExperimental Treatment1 Intervention

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.

Group VIII: ASD with depression, Sham then iTBSExperimental Treatment1 Intervention

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.

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