TMS for Autism

Overseen By James McPartland, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Cognitive-affecting drugs

Disqualifiers: Head trauma, Psychiatric illness, Seizures, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive procedure using magnetic fields to stimulate the brain, affects social understanding in adults with autism spectrum disorder (ASD). Participants will receive either real rTMS or a sham (fake) version to compare effects. The trial targets individuals aged 18 to 40 with autism who can participate in simple tests like eye-tracking. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in autism treatment.

Will I have to stop taking my current medications?

Yes, if you are taking prescription medications that may affect cognitive processes, you will need to stop taking them to participate in this trial.

What prior data suggests that Transcranial Magnetic Stimulation (TMS) is safe for adults with autism spectrum disorder (ASD)?

Research has shown that Transcranial Magnetic Stimulation (TMS) might help alleviate symptoms of autism spectrum disorder (ASD). TMS uses magnetic fields to activate nerve cells in the brain. Studies suggest it could reduce some ASD symptoms, but more evidence is needed.

Regarding safety, TMS is usually well-tolerated, with most people experiencing only mild side effects like headaches or scalp discomfort. Serious side effects are rare. Since the FDA has approved TMS for other conditions, there is some confidence in its safety. However, specific evidence for its use in ASD is still being gathered.

Prospective trial participants should consider these points and discuss them with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcranial Magnetic Stimulation (TMS) for autism because it offers a novel approach by using magnetic fields to stimulate nerve cells in the brain. Unlike typical medications for autism that often focus on managing symptoms like irritability or hyperactivity, TMS directly targets brain activity, potentially addressing core symptoms like social communication difficulties. This non-invasive method also stands out because it doesn't require medication, reducing the risk of side effects associated with pharmaceutical treatments.

What evidence suggests that Transcranial Magnetic Stimulation might be an effective treatment for autism?

Research has shown that Transcranial Magnetic Stimulation (TMS) could be a helpful tool for treating autism spectrum disorder (ASD). Studies suggest that TMS might reduce key symptoms of ASD, such as difficulties with social interactions and repetitive behaviors. A review of several studies found that repetitive TMS (rTMS) may improve social understanding and behavior in people with ASD. This trial will provide participants with either active TMS or sham stimulation to evaluate its effectiveness. While these findings are promising, more research is needed to confirm TMS's effectiveness for treating autism on a larger scale. Early results are hopeful, but ongoing studies will help determine how well TMS works for ASD. ^{1 2 3 4 5}

Who Is on the Research Team?

James McPartland, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-40 with autism spectrum disorder (ASD) or typical development, able to undergo EEG and eye-tracking tests. It excludes those with major psychiatric illnesses, pregnant women, individuals with an IQ below 80, history of seizures or serious medical conditions, recent drug/alcohol use, prior TMS therapy or investigational drug use within the last 12 weeks.

Inclusion Criteria

Individuals able to participate in an EEG and eye-tracking experiment

I am between 18 and 40 years old, with or without autism.

Exclusion Criteria

Participants who have taken alcohol or recreational drugs within the preceding 24 hours

Participants reporting significant head trauma or serious brain illness

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

1 day

1 visit (in-person)

Treatment

Participants receive either real or sham rTMS and undergo EEG and eye-tracking to measure neural and visual attentional social response

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

• Transcranial Magnetic Stimulation (TMS)

Trial Overview The study is testing repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain. The goal is to see how rTMS affects social cognition in adults with ASD.

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

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

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

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)
• Migraine Headache Symptoms

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

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

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]

Transcranial magnetic stimulation (TMS) shows promise as a safe treatment for cognitive and behavioral symptoms in intellectually capable individuals with autism spectrum disorder (IC-ASD), with a meta-analysis of 12 studies indicating significant improvements in cognitive outcomes and specific symptoms.

The study highlights the need for improved research methodologies, such as using neuronavigation and targeting different brain regions, to enhance the efficacy of TMS treatments in future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Response of Transcranial Magnetic Stimulation in Intellectually Capable Youth and Young Adults with Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. Smith, JR., DiSalvo, M., Green, A., et al.[2023]

Postmortem studies have found abnormalities in the peripheral neuropil space of cortical minicolumns in individuals with autism spectrum disorder (ASD), suggesting a potential target for treatment.

Repetitive transcranial magnetic stimulation (rTMS) has shown promise in improving motor symptoms, attention, and perceptual binding in ASD, marking it as the first therapeutic approach aimed at addressing core pathologies of the disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autism spectrum disorders: linking neuropathological findings to treatment with transcranial magnetic stimulation. Casanova, MF., Sokhadze, E., Opris, I., et al.[2015]

In a study of 165 pediatric participants aged 6 to 18, theta-burst TMS (TBS) demonstrated a similar safety profile to single- and paired-pulse TMS (sp/ppTMS), with no severe adverse effects reported.

The overall rate of adverse effects was 10.5% for TBS and 12.4% for sp/ppTMS, with most effects rated as minimal or mild, indicating that TBS is a safe option for further investigation in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of theta burst stimulation vs. single and paired pulse transcranial magnetic stimulation: a comparative study of 165 pediatric subjects. Hong, YH., Wu, SW., Pedapati, EV., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A multicenter randomized controlled trial is being conducted to evaluate the safety and efficacy of intermittent theta burst stimulation (iTBS) using rTMS on the right temporoparietal junction in 150 adolescents and young adults with autism spectrum disorder (ASD).

The study aims to improve social communication in participants over a 4-week treatment period, with assessments conducted before treatment and at multiple time points up to 6 months post-treatment, ensuring rigorous safety monitoring and ethical compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation (rTMS) in autism spectrum disorder: protocol for a multicentre randomised controlled clinical trial. Enticott, PG., Barlow, K., Guastella, AJ., et al.[2021]

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]

A review of 84 single pulse and paired-pulse TMS studies with 1091 Parkinson's disease patients, and 77 repetitive TMS studies with 1137 patients, found a very low risk of adverse events, with no seizures reported.

The overall risk of adverse events from rTMS was 0.040 per patient, with common side effects being mild and transient, such as headaches and scalp pain, indicating that TMS is generally safe for Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial magnetic stimulation in Parkinson's disease: a review of the literature. Vonloh, M., Chen, R., Kluger, B.[2021]

Theta burst stimulation (TBS) is a promising technique for altering brain excitability, with a review of studies showing that adverse events were mostly mild and occurred in only 5% of subjects, indicating a generally safe profile.

Despite its safety, TBS carries a theoretical higher risk of seizures compared to other stimulation methods, necessitating cautious application and further research into its dosing parameters to better understand seizure risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. Oberman, L., Edwards, D., Eldaief, M., 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4519010/

Use of Transcranial Magnetic Stimulation in Autism Spectrum ... Though preliminary data suggests promise, there is simply not enough evidence yet to conclusively support the clinical widespread use of TMS in ASD, neither ...

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. 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 ...

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

Repetitive Transcranial Magnetic Stimulation for Treatment ... Here we report the results of a systematic literature review and meta-analysis on the use of rTMS to treat ASD.

5. link.springer.com link.springer.com/article/10.1007/s10803-024-06244-2

Accelerated Theta Burst Transcranial Magnetic Stimulation ... Accelerated Theta Burst Transcranial Magnetic Stimulation for Refractory Depression in Autism Spectrum Disorder. Original Article; Open access ...