Transcranial Magnetic Stimulation for Autism

Overseen By Ryan Ally, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Christiana Care Health Services

Disqualifiers: Significant anxiety, Seizures, Metallic implants, others

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

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Transcranial Magnetic Stimulation (rTMS) to assist individuals with Autism Spectrum Disorder (ASD). Researchers aim to determine if rTMS can improve social skills by altering brain cell connections and communication in areas affecting social interaction. The trial consists of two parts: initially, some participants will receive the real treatment while others receive a placebo; later, all participants will receive the real treatment. Suitable candidates have an ASD diagnosis but should not have severe anxiety, seizures, or metal implants in the head or neck. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance social skills in individuals with ASD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Previous studies have examined transcranial magnetic stimulation (TMS) as a treatment for autism. Research shows that TMS might help reduce autism symptoms. Safety data indicates that about 25% of people with autism experience side effects from TMS. However, researchers have not identified specific risk factors for these side effects in people with autism.

These side effects are usually mild, and TMS is considered a safe and noninvasive treatment option when used at low levels. While the results are promising, further research is needed to fully understand the safety of TMS for people with autism. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Magnetic Stimulation (TMS) is unique because it uses magnetic fields to stimulate nerve cells in the brain, which is a different approach from the usual behavioral therapies and medications for autism. While most current treatments focus on managing symptoms through behavioral interventions or medications that adjust neurotransmitter levels, TMS directly targets specific areas of the brain that may be involved in autism. Researchers are excited about TMS because it offers a non-invasive method that could potentially influence brain activity and improve symptoms more directly, with fewer side effects compared to medication.

What evidence suggests that Transcranial Magnetic Stimulation is effective for autism?

Research has shown that transcranial magnetic stimulation (TMS) might help improve some symptoms of autism spectrum disorder (ASD). A review of several studies found that TMS led to noticeable improvements in language and social behavior. Another study demonstrated that using TMS on a specific part of the brain reduced symptoms in children with ASD. These findings suggest that TMS could benefit certain aspects of autism, but the evidence isn't yet strong enough for widespread use. The initial results are promising, but more research is needed to confirm them. In this trial, participants will first be divided into two groups: one receiving real TMS and the other receiving sham stimulation. In the second phase, all participants will receive active TMS to further evaluate its effects. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with Autism Spectrum Disorder (ASD) at level 1 or 2, meaning they have some difficulties with social communication and may exhibit repetitive behaviors. Participants should not have a history of epilepsy or seizures and must not have any metallic devices in their head or neck.

Inclusion Criteria

ASD level 1 or 2

Exclusion Criteria

Presence of metallic devices in the head or neck

I have a history of epilepsy or seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 (Sham Comparator)

Half of the subjects receive rTMS, while the other half receive sham stimulation

3 weeks

Phase 2 (Active Comparator)

All subjects receive active rTMS stimulation

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation

Trial Overview The study is testing the effects of transcranial magnetic stimulation (rTMS) on the 'social reciprocity network'—a proposed area of the brain involved in social interaction—in people with ASD. It aims to see if rTMS can improve connectivity within this network and enhance social cognition by using QEEG coherence/spectral power analysis.

How Is the Trial Designed?

Group I: phase 2 Active Control 1 Intervention

During phase II (3 weeks) all subjects will receive active stimulation.

Group II: phase 1 Placebo Group 1 Intervention

During phase I (3 weeks), half of the subjects will receive rTMS, while the other half will receive sham stimulation.

Who Is Running the Clinical Trial?

Christiana Care Health Services

Lead Sponsor

Trials

118

Recruited

204,000+

Published Research Related to This Trial

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 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) 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]

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 10 children with autism, the application of pico-Tesla Transcranial Magnetic Stimulation (pT-TMS) resulted in significant increases in brain frequencies (2-7 Hz) and improved MEG recordings in 60% of the participants.

After one month of pT-TMS treatment, there was a notable increase in alpha brain activity, suggesting that this noninvasive technique could be a safe and effective management option for children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A combined study of MEG and pico-Tesla TMS on children with autism disorder. Anninos, P., Chatzimichael, A., Adamopoulos, A., et al.[2017]

High-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the left premotor cortex significantly improved eye-hand integration tasks in children with low-functioning autism, with effects lasting up to 1 hour after stimulation.

Combining rTMS with traditional eye-hand integration training resulted in even better performance outcomes, suggesting that this combined approach may enhance rehabilitation strategies for children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of repetitive transcranial magnetic stimulation in performing eye-hand integration tasks: four preliminary studies with children showing low-functioning autism. Panerai, S., Tasca, D., Lanuzza, B., et al.[2015]

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]

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 ... Among them, six studies reported significant improvements in language and social behavior, as evidenced by decreased scores on the respective ...

3. 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.

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

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

5. 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 ...

6. 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.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02591446

Transcranial Magnetic Stimulation Studies in Autism ... Investigators thus anticipate that data from the proposed studies will address an important need for a rapid, noninvasive, reliable and safe endophenotype ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7477302/

Transcranial Magnetic Stimulation in Autism Spectrum Disorders When applied at low frequencies in individuals with ASD, TMS appears to be safe and to improve multiple patient-oriented outcomes. Future ...