60 Participants Needed

TMS for Depression in Autism Spectrum Disorder

ST
Overseen BySherab Tsheringla, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial requires that participants either be unmedicated or on a stable medication treatment for at least two weeks. If you are taking medications that affect cognitive processes or increase seizure risk, you may need to stop those.

Is TMS safe for treating depression in individuals with autism?

Research suggests that TMS, including rTMS and iTBS, is generally well tolerated and safe for individuals with autism and depression, with mild side effects reported in studies.12345

How is TMS treatment different for depression in autism spectrum disorder?

Transcranial Magnetic Stimulation (TMS) is a unique treatment for depression in autism spectrum disorder because it is a non-invasive brain stimulation technique that uses magnetic fields to stimulate nerve cells in the brain, unlike traditional drug therapies. It has shown promise in improving depressive symptoms and possibly core autism symptoms, offering an alternative for those who may not respond well to medication.12467

What data supports the effectiveness of the treatment Transcranial Magnetic Stimulation (TMS) for depression in individuals with Autism Spectrum Disorder?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can improve depression symptoms in adults with both autism and major depressive disorder, with 40% of participants achieving remission in one study. Additionally, some studies suggest potential benefits for core autism symptoms, although more research is needed to confirm these effects.23467

Who Is on the Research Team?

ST

Sherab Tsheringla, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have not changed my medications in the last two weeks.
If your depression score is 20 or higher on the HDRS-17 test, you will not be able to participate.
You are able and willing to take part in an EEG and eye-tracking test.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Baseline assessment of neuropsychological, cognitive, and behavioral function, along with EEG and eye-tracking

1 week
1 visit (in-person)

Treatment

Participants receive a single iTBS session or sham stimulation, with EEG and eye-tracking assessments pre-and-post stimulation

1 week
1 visit (in-person)

Crossover Treatment

Participants crossover to receive the alternate treatment (iTBS or sham) with EEG and eye-tracking assessments pre-and-post stimulation

1 week
1 visit (in-person)

Follow-up

Participants are monitored for changes in EEG, eye-tracking, and behavioral measures

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Transcranial Magnetic Stimulation (TMS)
Trial Overview 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.
How Is the Trial Designed?
8Treatment groups
Experimental Treatment
Group I: TD without depression, iTBS then ShamExperimental Treatment1 Intervention
Group II: TD without depression, Sham then iTBSExperimental Treatment1 Intervention
Group III: TD with depression, iTBS then ShamExperimental Treatment1 Intervention
Group IV: TD with depression, Sham then iTBSExperimental Treatment1 Intervention
Group V: ASD without depression, iTBS then ShamExperimental Treatment1 Intervention
Group VI: ASD without depression, Sham then iTBSExperimental Treatment1 Intervention
Group VII: ASD with depression, iTBS then ShamExperimental Treatment1 Intervention
Group VIII: ASD with depression, Sham then iTBSExperimental Treatment1 Intervention

Transcranial Magnetic Stimulation (TMS) is already approved in United States, European Union for the following indications:

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Approved in United States as Transcranial Magnetic Stimulation (TMS) for:
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Approved in European Union as Transcranial Magnetic Stimulation (TMS) for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

American Academy of Child Adolescent Psychiatry.

Collaborator

Trials
14
Recruited
1,000+

Published Research Related to This Trial

In a study involving 13 adults with autism spectrum disorder (ASD) and major depressive disorder (MDD), repetitive transcranial magnetic stimulation (rTMS) was found to be well tolerated, with mild side effects reported.
Participants experienced a significant reduction in depressive symptoms, with an average improvement of 13.5 points on the Hamilton rating scale for depression, and 40% achieved remission, suggesting rTMS may be an effective treatment for depression in individuals with ASD.
Treatment of Adults with Autism and Major Depressive Disorder Using Transcranial Magnetic Stimulation: An Open Label Pilot Study.Gwynette, MF., Lowe, DW., Henneberry, EA., et al.[2023]
A retrospective analysis of 18 individuals with autism spectrum disorder (ASD) who did not respond to traditional depression treatments showed that intermittent theta burst stimulation (iTBS) therapy may help alleviate depressive symptoms.
While the results are promising, they are based on a small case series, highlighting the need for larger, randomized trials to confirm the efficacy of TMS therapies for treating depression in individuals with ASD.
A Case Series of Intermittent Theta Burst Stimulation Treatment for Depressive Symptoms in Individuals with Autistic Spectrum Disorder: Real World TMS Study in the Tokyo Metropolitan Area.Noda, Y., Fujii, K., Mimura, Y., et al.[2023]
In a pilot study involving 13 adults with autism spectrum disorder (ASD), intermittent theta burst stimulation (iTBS) applied over the bilateral posterior superior temporal sulcus (pSTS) showed significant immediate improvements in parent-rated autistic symptoms after 5 days of treatment.
The effectiveness of iTBS on cognitive flexibility and clinical symptoms was influenced by individual factors such as baseline social-communicative impairment, cognitive performance, and concurrent psychotropic medication use, highlighting the need for personalized approaches in future trials.
5-day multi-session intermittent theta burst stimulation over bilateral posterior superior temporal sulci in adults with autism-a pilot study.Ni, HC., Lin, HY., Chen, YL., et al.[2022]

Citations

Treatment of Adults with Autism and Major Depressive Disorder Using Transcranial Magnetic Stimulation: An Open Label Pilot Study. [2023]
A Case Series of Intermittent Theta Burst Stimulation Treatment for Depressive Symptoms in Individuals with Autistic Spectrum Disorder: Real World TMS Study in the Tokyo Metropolitan Area. [2023]
5-day multi-session intermittent theta burst stimulation over bilateral posterior superior temporal sulci in adults with autism-a pilot study. [2022]
Repetitive transcranial magnetic stimulation (rTMS) improves movement-related cortical potentials in autism spectrum disorders. [2022]
Repetitive Transcranial Magnetic Stimulation for Treatment of Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. [2020]
Prevalence of Adverse Effects Associated With Transcranial Magnetic Stimulation for Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. [2022]
A double-blind, randomized trial of deep repetitive transcranial magnetic stimulation (rTMS) for autism spectrum disorder. [2018]
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