TMS for Autism Spectrum Disorder

(TMSinASD Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Cognitive-affecting medications

Disqualifiers: Head trauma, Psychiatric illness, Seizures, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the impact of repetitive Transcranial Magnetic Stimulation (rTMS) on social skills and brain activity in individuals with Autism Spectrum Disorder (ASD). Participants will undergo brain and behavior tests, including EEG (which records brain waves) and eye-tracking, to measure changes before and after TMS treatment. The trial includes two groups: one receiving real TMS and another receiving a sham (fake) treatment for comparison. Suitable candidates for this trial are individuals aged 18-40 with ASD or typical development who can participate in EEG and eye-tracking tests. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance the understanding and treatment of ASD.

Will I have to stop taking my current medications?

The trial excludes participants taking prescription medications that may affect cognitive processes, so you might need to stop certain medications. The protocol does not specify which medications, so it's best to discuss your current medications with the trial team.

What prior data suggests that Transcranial Magnetic Stimulation is safe for Autism Spectrum Disorder?

Research has shown that Transcranial Magnetic Stimulation (TMS) is generally safe for individuals with Autism Spectrum Disorder (ASD). Studies suggest that TMS can alleviate ASD symptoms, and previous patients have tolerated the treatment well.

In one detailed review of multiple studies, about 25% of individuals with ASD reported side effects from TMS. Importantly, these side effects were not specifically linked to having ASD, indicating that the treatment is usually well-tolerated by this group.

Overall, while some participants may experience side effects, many do not, and the treatment is generally considered safe for most individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcranial Magnetic Stimulation (TMS) for Autism Spectrum Disorder because it offers a non-invasive way to potentially improve brain function. Unlike standard treatments like behavioral therapy and medications, TMS uses magnetic fields to stimulate nerve cells in the brain, which could lead to improvements in social communication and repetitive behaviors. This technique is unique because it targets specific brain areas without the need for medication, reducing the risk of side effects. Researchers hope this approach could provide a new avenue for managing autism symptoms more effectively.

What evidence suggests that TMS might be an effective treatment for Autism Spectrum Disorder?

Studies have shown that Transcranial Magnetic Stimulation (TMS) is a promising method for treating Autism Spectrum Disorder (ASD). TMS can help reduce the main symptoms of ASD by changing brain activity. This trial will compare two different approaches: participants in one arm will receive active TMS, while those in another arm will receive sham stimulation simulating TMS. This treatment has the potential to improve social skills and thinking abilities in people with ASD. Some studies suggest that these improvements can last for up to six months. However, while the results are encouraging, they should be viewed with caution as more research is needed to confirm these findings. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-40 with either typical development or a diagnosis of Autism Spectrum Disorder (ASD). They must be able to undergo EEG and eye-tracking tests. It's not suitable for those with serious brain issues, major psychiatric illnesses, medical conditions like stroke or seizures, recent drug/alcohol use, pregnant women, or anyone with metal in their body.

Inclusion Criteria

You are able to take part in a test that involves an EEG (a brain activity measurement) and eye-tracking.

Exclusion Criteria

Participants with major psychiatric illness that would preclude completion of study measures

You have consumed alcohol or used recreational drugs within the past day.

I am not pregnant nor suspect I might be.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessment of neuropsychological, cognitive, and behavioral function, including EEG and eye-tracking session

1 day

1 visit (in-person)

Treatment

Participants receive either active or sham TMS during their study visit

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TMS

Trial Overview The study is testing the impact of repetitive Transcranial Magnetic Stimulation (rTMS) on how people with ASD process social information. This involves looking at changes in brain activity and behavior before and after TMS using EEGs and eye-tracking technology.

How Is the Trial Designed?

Group I: Transcranial Magnetic Stimulation - real Active Control 1 Intervention

Participants will receive active TMS during their study visit

Group II: Transcranial Magnetic Stimulation - sham Placebo Group 1 Intervention

Participants will receive sham stimulation during their study visit simulating TMS

TMS is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Transcranial Magnetic Stimulation for:

• Depression
• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in European Union as Transcranial Magnetic Stimulation for:

• Depression
• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in Canada as Transcranial Magnetic Stimulation for:

• Depression
• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Published Research Related to This Trial

Transcranial magnetic stimulation (TMS) targets a core feature of autism spectrum disorder (ASD) by addressing cortical inhibitory imbalances, leading to improved executive function and reduced stimulus-bound behaviors in individuals with ASD.

TMS has been shown to be safe and effective, with benefits increasing with the number of sessions, and it may work even better when combined with neurofeedback, highlighting the need for further research in larger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation in Autism Spectrum Disorders: Neuropathological Underpinnings and Clinical Correlations. Casanova, MF., Sokhadze, EM., Casanova, EL., et al.[2021]

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]

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]

A systematic review of 23 studies on repetitive Transcranial Magnetic Stimulation (rTMS) for Autism Spectrum Disorder (ASD) showed a moderate effect in improving repetitive behaviors, social behavior, and executive function tasks, but results should be interpreted cautiously due to potential biases in the studies.

Only a few studies indicated that the benefits of rTMS could last for up to 6 months, highlighting the need for more rigorous, controlled trials to better understand the treatment's efficacy and optimal parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation for Treatment of Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. Barahona-Corrêa, JB., Velosa, A., Chainho, A., et al.[2020]

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]

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 children with low-function autism, those who received low-frequency repetitive transcranial magnetic stimulation (rTMS) showed significant improvements in brain activity, particularly in peak alpha frequency and coherence, compared to a waitlist group.

The rTMS treatment also led to positive changes in behavior as measured by the Autism Behavior Checklist, indicating that rTMS may be an effective neurotherapy for enhancing cognitive and behavioral outcomes in children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of repetitive transcranial magnetic stimulation on children with low-function autism. Kang, JN., Song, JJ., Casanova, MF., 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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30038561/

Repetitive Transcranial Magnetic Stimulation for Treatment ... Only 5 studies reported stability of these gains for periods of up 6 months, with descriptions that improvements were sustained over time.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024082823

A systematic review of transcranial magnetic stimulation ... Transcranial magnetic stimulation (TMS) is a promising and emerging tool for the intervention of ASD by reducing both core and associate symptoms.

3. frontiersin.org frontiersin.org/journals/integrative-neuroscience/articles/10.3389/fnint.2018.00027/full

Repetitive Transcranial Magnetic Stimulation for Treatment ... Conclusions: Existing evidence supports that TMS could be useful to treat some dimensions of ASD. However, such evidence must be regarded with care, as most ...

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-08946-z

Repetitive transcranial magnetic stimulation in children ... - Trials Currently, rTMS is considered a promising therapeutic tool because of its ability to modulate brain activity linked to ASD and its non-invasive ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/70/NCT05472870/Prot_SAP_000.pdf

Efficacy and mechanistic of repeated transcranial magnetic ... stimulation (a-cTBS) over left primary motor cortex (M1) can improve clinical symptoms of children with autism spectrum disorder (ASD) in China.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8264904/

Repetitive transcranial magnetic stimulation (rTMS) in autism ... A double-blind, randomized trial of deep repetitive transcranial magnetic stimulation (rTMS) for autism spectrum disorder. Brain Stimul 2014 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36161554/

Treatment Response of Transcranial Magnetic Stimulation in ... The results of our systematic review and meta-analysis data indicate that TMS may offer a promising and safe treatment option for pediatric and young adult ...

8. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.875591/full

A Systematic Review and Meta-Analysis The overall prevalence of reported AEs of TMS among ASD was 25%. No identified ASD-specific risk factors for TMS-induced AEs were found.

9. clinicaltrials.gov 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 ...