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

Trial Summary

What is the purpose of this trial?

There is no consensus regarding the neurological substrate underpinning ASD. The investigators describe the novel concept of "social reciprocity network" and hypothesize that aberrant connectivity/oscillatory patterns affecting this network contribute to the core deficits in ASD. The overarching goal of this trial is to explore abnormalities involving the neuronal connectivity and oscillatory patterns within the social reciprocity network and to elucidate the role of modulating this network via rTMS in improving the above measures and social cognition in ASD. Quantitative electroencephalography (QEEG) coherence and spectral power analysis are reliable measures of neuronal connectivity and dynamics. The investigators aim to study the QEEG coherence/spectral power analysis to explore the neuronal dynamics affecting the social reciprocity network in 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 data supports the effectiveness of the treatment Transcranial Magnetic Stimulation for Autism?

Research shows that Transcranial Magnetic Stimulation (TMS) can improve attention and reduce repetitive behaviors in individuals with autism. Studies found that TMS helps with brain activity related to attention and behavior, and combining it with other therapies can enhance its benefits. ^{1 2 3 4 5}

How does transcranial magnetic stimulation treatment differ from other treatments for autism?

Transcranial magnetic stimulation (TMS) is unique because it targets a core issue in autism, the imbalance in brain activity, by using magnetic fields to stimulate specific brain areas. Unlike other treatments that focus on symptoms, TMS aims to improve brain function directly, potentially leading to better self-control and reduced repetitive behaviors. ^{2 3 6 7 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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) 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]

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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

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

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. England 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. [2015]

5. United States 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. [2023]

6. 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]

7. Singapore pubmed.ncbi.nlm.nih.gov

A combined study of MEG and pico-Tesla TMS on children with autism disorder. [2017]

8. England pubmed.ncbi.nlm.nih.gov

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