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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,501 Total Patients Enrolled

26 Trials studying Autism Spectrum Disorder

2,327 Patients Enrolled for Autism Spectrum Disorder

American Academy of Child Adolescent Psychiatry.OTHER

13 Previous Clinical Trials

1,050 Total Patients Enrolled

Sherab Tsheringla, MDPrincipal InvestigatorYale University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for enrollment in this trial greater than 35 years old?

"Eligible participants for this research must be between 18 and 40 years of age."

Answered by AI

Does this scientific trial have vacancies for participants?

"According to clinicaltrials.gov, this medical trial has finished recruiting patients as of November 15th 2023 and is no longer taking on new ones. However, there are currently 323 other trials that remain open for enrollment."

Answered by AI

Is there a set of criteria for individuals to be eligible for participation in this trial?

"Patients with autism spectrum disorder between the ages of 18 and 40 have an opportunity to participate in this research. Our team is targeting a sample size of 60 for the duration of the trial."

Answered by AI

What results are researchers hoping to glean from this trial?

"The intention of this research, to be assessed over the baseline period and up to week two, is to measure changes in eye tracking (ET) when exposed to sad faces. Secondary objectives include evaluating ET responses towards different emotionally charged facial expressions; amplitude and latency of right lateralized N170 as recorded from eye-fixation potentials while observing emotive visages; amount of attention directed at neutral faces or non-social stimuli displayed on a screen; proportion of fixations directed at eyes within neutral countenances or non-social images such as houses; finally, Frith Happé Animations Task will assess latency in looking towards the orbital"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Transcranial Magnetic Stimulation (TMS) to Treat Depression in Autism Spectrum Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06142955.

All > Autism New York > Transcranial Magnetic Stimulation