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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test if using magnetic pulses can improve social skills in adults with Autism Spectrum Disorder (ASD). The study will measure brain and behavior changes over time. Magnetic stimulation has been explored in various studies as a potential treatment for autism spectrum disorder (ASD), showing positive behavioral and brain activity results.

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 data supports the effectiveness of the treatment TMS for Autism Spectrum Disorder?

Research suggests that repetitive Transcranial Magnetic Stimulation (rTMS) may help improve certain symptoms of autism, such as social behavior and repetitive actions, by targeting brain activity. Some studies show improvements in attention and behavior after rTMS, but more research is needed to confirm these findings and determine the best way to use this treatment. ^{1 2 3 4 5}

How is TMS treatment different from other treatments for autism spectrum disorder?

TMS (Transcranial Magnetic Stimulation) is unique because it is a non-invasive treatment that uses magnetic fields to stimulate specific areas of the brain, potentially improving motor function and social behaviors in autism spectrum disorder (ASD). Unlike other treatments, TMS does not involve medication and is still being studied for its effectiveness and optimal use in ASD. ^{4 6 7 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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]

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]

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 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 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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation in Autism Spectrum Disorders: Neuropathological Underpinnings and Clinical Correlations. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of 1Hz repetitive transcranial magnetic stimulation on autism with intellectual disability: A pilot study. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation for Treatment of Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation (rTMS) Modulates Event-Related Potential (ERP) Indices of Attention in Autism. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation (rTMS) improves movement-related cortical potentials in autism spectrum disorders. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Effects of repetitive transcranial magnetic stimulation on children with low-function autism. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Prevalence of Adverse Effects Associated With Transcranial Magnetic Stimulation for Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A double-blind, randomized trial of deep repetitive transcranial magnetic stimulation (rTMS) for autism spectrum disorder. [2018]