Transcranial Magnetic Stimulation for Autism Spectrum Disorder

Overseen By Vaughn R Steele, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Psychotropics, Anticonvulsants

Disqualifiers: Neurological disorder, Major medical condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 3 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how transcranial magnetic stimulation (TMS), a non-invasive brain stimulation technique, affects brain activity related to social understanding in young adults with autism. Researchers aim to determine if TMS can alter brain processing of social interactions by targeting a specific area involved in understanding others. Participants will undergo several sessions involving TMS and brain scans. The study seeks right-handed, English-fluent individuals with autism who have no history of neurological disorders or significant head injuries. As an unphased study, this trial offers participants the chance to contribute to groundbreaking research in autism and social cognition.

Will I have to stop taking my current medications?

The trial requires that participants with autism have a stable medication treatment for at least 4 weeks before joining the study. If you are on medications, you should not change them during this period before the trial.

What prior data suggests that transcranial magnetic stimulation is safe for young adults with autism?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) may help with autism spectrum disorder (ASD). Studies suggest that rTMS could lessen some main symptoms of ASD. However, considering its safety is important.

A review found that about 25% of people with ASD experienced side effects from rTMS. Common side effects include headaches or mild discomfort at the treatment site, but serious problems are rare. No specific risk factors for these side effects in people with ASD have been identified.

Overall, while rTMS might offer benefits, participants should discuss any concerns with the trial team to fully understand the possible benefits and risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial magnetic stimulation (TMS) for Autism Spectrum Disorder (ASD) because it offers a non-invasive brain stimulation technique that could potentially enhance social cognitive functions by targeting specific brain areas. While current treatments for ASD often include behavioral therapy and medication to manage symptoms, TMS directly influences brain activity using magnetic fields, which could lead to improvements in social interactions and communication. This technique is particularly promising because it is precise in targeting the right temporoparietal junction (TPJ), a brain region associated with understanding others' thoughts and feelings, potentially leading to more effective interventions for individuals with ASD.

What evidence suggests that transcranial magnetic stimulation is effective for autism?

Research suggests that transcranial magnetic stimulation (TMS) might improve symptoms of autism spectrum disorder (ASD). Some studies have found that TMS can enhance language skills and social behaviors. Specifically, several reports showed improvements in social communication, a common challenge for people with ASD. While these early results are promising, more research is needed to confirm TMS's effectiveness for ASD. In this trial, participants will receive excitatory, inhibitory, and sham rTMS to the right temporoparietal junction (TPJ) to assess its effects on mentalizing task-related activity. The treatment uses magnetic fields to stimulate specific brain areas, potentially aiding social interaction for those with ASD. ^{2 5 6 7 8}

Who Is on the Research Team?

Vaughn Steele, MD

Principal Investigator

Yale University

Michal Assaf, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for young adults with Autism Spectrum Disorder (ASD) who can undergo MRI scans and TMS sessions. It's not suitable for individuals without ASD or those who cannot safely have these procedures due to other medical conditions.

Inclusion Criteria

I don't have psychiatric disorders, except maybe simple phobia, and no family history of ASD.

None of my close relatives have had hereditary neurological disorders.

I have never had a serious head injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo assessment of clinical traits, social skills, and a baseline MRI scan

1 week

1 visit (in-person)

Treatment

Participants receive three rTMS sessions (excitatory, inhibitory, sham) with pre- and post-fMRI scans

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in mentalizing task-related neural activity

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• rTMS

Trial Overview

The study tests if transcranial magnetic stimulation (TMS) at the right temporoparietal junction affects brain activity related to social understanding in people with autism, compared to non-autistic individuals.

How Is the Trial Designed?

Group I: Typically Developing (TD): excitatory, then inhibitory, then sham rTMS Experimental Treatment 2 Interventions

Participants in this group will undergo fMRI pre- and post- rTMS. Each will receive an excitatory, inhibitory and sham rTMS to the right temporoparietal junction (TPJ) on mentalizing task-related (MTR) activity over 4 study visits.

Group II: ASD: excitatory, then inhibitory, then sham rTMS Experimental Treatment 2 Interventions

Participants in this group will undergo fMRI pre- and post- rTMS. Each will receive an excitatory, inhibitory and sham rTMS to the right temporoparietal junction (TPJ) on mentalizing task-related (MTR) activity over 4 study visits.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study involving 11 participants with autism spectrum disorders (ASD), repetitive transcranial magnetic stimulation (rTMS) was found to enhance movement-related cortical potentials (MRCPs), indicating improved motor function.

Specifically, rTMS applied to the supplementary motor area (SMA) increased early MRCP components, while stimulation of the left primary motor cortex (M1) affected later components, suggesting that rTMS may influence cortical inhibitory processes to enhance motor activity in individuals with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation (rTMS) improves movement-related cortical potentials in autism spectrum disorders. Enticott, PG., Rinehart, NJ., Tonge, BJ., et al.[2022]

In a study involving 32 autistic children with intellectual disabilities, 1 Hz repetitive transcranial magnetic stimulation (rTMS) was found to significantly improve brain activity, as indicated by changes in electroencephalogram (EEG) measures like recursive rate and deterministic features.

The experimental group receiving rTMS also showed notable improvements in behavior, as reflected in the Autism Behavior Checklist scores, suggesting that rTMS may be a beneficial intervention for enhancing both brain function and behavioral outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 1Hz repetitive transcranial magnetic stimulation on autism with intellectual disability: A pilot study. Kang, J., Zhang, Z., Wan, L., et al.[2022]

In a study involving 28 adults with autism spectrum disorder, deep repetitive transcranial magnetic stimulation (rTMS) targeting the dorsomedial prefrontal cortex showed a significant reduction in social relating symptoms compared to a sham treatment.

Participants receiving active rTMS also experienced decreased anxiety in social situations, suggesting that this technique may improve both social functioning and emotional responses in individuals with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, randomized trial of deep repetitive transcranial magnetic stimulation (rTMS) for autism spectrum disorder. Enticott, PG., Fitzgibbon, BM., Kennedy, HA., et al.[2018]

After 12 sessions of low-frequency rTMS applied to the dorsolateral prefrontal cortices, individuals with autism spectrum disorder (ASD) showed significant improvements in event-related potentials (N200 and P300) related to selective attention, indicating enhanced cognitive processing.

Participants also experienced a reduction in motor response errors, repetitive behaviors, and irritability, suggesting that rTMS may be a promising therapeutic tool for improving attention and behavioral symptoms in ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation (rTMS) Modulates Event-Related Potential (ERP) Indices of Attention in Autism. Casanova, MF., Baruth, JM., El-Baz, A., et al.[2021]

Transcranial magnetic stimulation (TMS) has a reported overall adverse effect (AE) prevalence of 25% in individuals with autism spectrum disorder (ASD), with most AEs being mild and transient, such as headache (10%) and irritability (21%).

No specific risk factors related to ASD were identified that influenced the prevalence of AEs from TMS, suggesting that TMS may be a safe therapeutic option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of Adverse Effects Associated With Transcranial Magnetic Stimulation for Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. Huashuang, Z., Yang, L., Chensheng, H., et al.[2022]

In a study involving 13 patients with autism and 13 controls, low frequency repetitive transcranial magnetic stimulation (rTMS) was applied twice a week for 3 weeks, leading to significant improvements in event-related potentials and behavioral measures.

The findings suggest that rTMS may enhance the inhibitory function of minicolumns in the brain, indicating its potential as a therapeutic intervention for autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of low frequency repetitive transcranial magnetic stimulation (rTMS) on gamma frequency oscillations and event-related potentials during processing of illusory figures in autism. Sokhadze, EM., El-Baz, A., Baruth, J., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Deep transcranial magnetic stimulation (dTMS) over the medial prefrontal cortex significantly reduced repetitive behaviors and improved emotional recognition and cognitive abilities in two young patients with high-functioning Autism after 5-6 weeks of treatment.

The treatment, which involved daily high-frequency (5 Hz) dTMS, appears to enhance sociability and communication skills, suggesting that dTMS may positively influence brain networks related to social cognition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced cognition and emotional recognition, and reduced obsessive compulsive symptoms in two adults with high-functioning autism as a result of deep Transcranial Magnetic Stimulation (dTMS): a case report. Avirame, K., Stehberg, J., Todder, D.[2018]

Repetitive transcranial magnetic stimulation (rTMS) is a powerful tool that can effectively treat clinical depression and potentially other brain disorders, but it carries risks, including the potential to induce seizures, as evidenced by 7 known cases by 1996.

A workshop established safety guidelines for rTMS, emphasizing the importance of monitoring, ethical considerations, and the expertise required for its administration to minimize risks and enhance therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Wassermann, EM.[2022]

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.

The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Kim, WS., Paik, NJ.[2023]

Citations

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The overall prevalence of reported AEs of TMS among ASD was 25%. No identified ASD-specific risk factors for TMS-induced AEs were found.

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clinicaltrials.gov/study/NCT04532424

Transcranial Magnetic Stimulation for Restricted and ...

Investigating the efficacy of a form of TMS called theta-burst stimulation for restricted and repetitive behavior in ASD. Official Title. Transcranial Magnetic ...