rTMS for Autism

Overseen By Trina Mitchell, PhD

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Holland Bloorview Kids Rehabilitation Hospital

Disqualifiers: No self-regulation disorders, Seizures, Neurological conditions, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 15

Duration: 3 weeks

50 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the rTMS for Autism trial?

The trial protocol does not specify whether you need to stop taking your current medications.

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 idea that rTMS for Autism is an effective treatment?

The available research shows that repetitive transcranial magnetic stimulation (rTMS) can be an effective treatment for autism. Studies have found that rTMS can improve attention and reduce repetitive behaviors and irritability in children with autism. For example, one study showed significant improvements in attention and a reduction in response errors after 12 sessions of rTMS. Another study found improvements in behavior and brain activity after rTMS sessions. Additionally, in adults with both autism and depression, rTMS was shown to improve depressive symptoms and possibly core autism symptoms, according to family assessments. These findings suggest that rTMS has potential as a therapeutic tool for autism. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment rTMS for autism?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can improve attention and reduce repetitive behaviors in children with autism. Studies also suggest that rTMS may help with symptoms of autism in adults who also have depression, indicating potential benefits for core autism symptoms. ^{1 2 3 4 5}

What safety data exists for rTMS treatment in autism?

Safety data for rTMS in autism includes systematic reviews and guidelines. A systematic review and meta-analysis have evaluated the prevalence of adverse effects of TMS in autism spectrum disorder. General safety guidelines for rTMS, established in 1996 and updated in 2008 and 2021, cover potential adverse events, precautions, dosing considerations, and specific conditions like stroke and traumatic brain injury. Historical data from 1996 noted 7 known seizures caused by rTMS, highlighting the need for careful monitoring and guidelines. Overall, rTMS is considered safe when applied with proper guidelines and precautions. ^{6 7 8 9 10}

Is repetitive transcranial magnetic stimulation (rTMS) safe for humans?

Repetitive transcranial magnetic stimulation (rTMS) has been used safely in both healthy individuals and those with various brain disorders, with safety guidelines established since 1996 and updated in 2021. While it has caused seizures in rare cases, it is generally considered safe when following established guidelines. ^{6 7 8 9 10}

Is repetitive transcranial magnetic stimulation (rTMS) a promising treatment for autism?

Yes, repetitive transcranial magnetic stimulation (rTMS) is a promising treatment for autism. Studies show it can help improve social skills, reduce repetitive behaviors, and enhance motor functions in people with autism. It is a noninvasive technique that has shown positive effects on brain activity and behavior in autistic individuals. ^{1 2 5 7 10}

How does the treatment rTMS differ from other treatments for autism?

Repetitive transcranial magnetic stimulation (rTMS) is a unique treatment for autism because it is a noninvasive brain stimulation technique that uses magnetic fields to target specific areas of the brain. Unlike traditional therapies, rTMS directly influences brain activity and has shown potential benefits in improving social behavior and motor function in individuals with autism. ^{1 2 5 7 10}

What is the purpose of this trial?

This trial will test if using magnetic fields to stimulate the brain can help children and youth with autism manage their emotions better and reduce disruptive behaviors. The study will observe the effects over a short period to see if it works.

Research Team

Deryk Beal, PhD, Reg. CASLPO, CCC-SLP

Principal Investigator

Holland Bloorview Research Institute

Eligibility Criteria

This trial is for children with Autism Spectrum Disorder who struggle with self-regulation. They must be able to undergo rTMS treatment safely, meaning no history of seizures, family history of seizures, metal implants in the body, or other neurological conditions like epilepsy.

Inclusion Criteria

I can undergo rTMS treatment.

My child has autism and struggles with self-regulation.

Exclusion Criteria

I have a neurological condition like epilepsy or have had a stroke.

Children with contraindications to TMS (history of seizures, family history of seizures, metal implants)

My child has autism but does not have any self-regulation disorders.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 15 sessions of rTMS or sham stimulation over 3 weeks

3 weeks

15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including behavioral assessments and MRI

15 weeks

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• repetitive transcranial magnetic stimulation (rTMS)
• Sham stimulation

Trial Overview The study tests if repetitive Transcranial Magnetic Stimulation (rTMS) can help kids with Autism manage their emotions and behaviors better. It includes a comparison between actual rTMS and sham (fake) stimulation alongside behavioral assessments and MRI scans before and after treatment.

Participant Groups

Group I: repetitive transcranial magnetic stimulation (rTMS) Experimental Treatment 1 Intervention

Participants will receive 15 rTMS sessions for 3 weeks.

Group II: Sham Placebo Group 1 Intervention

Participants will receive 15 sessions of sham stimulation for 3 weeks.

repetitive transcranial magnetic stimulation (rTMS) is already approved in United States, European Union for the following indications:

Approved in United States as TMS for:

• Major Depressive Disorder
• Obsessive-Compulsive Disorder

Approved in European Union as TMS for:

• Major Depressive Disorder

Who Is Running the Clinical Trial?

Holland Bloorview Kids Rehabilitation Hospital

Lead Sponsor

Trials

69

Recruited

14,100+

Centre for Addiction and Mental Health

Collaborator

Trials

388

Recruited

84,200+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

Findings from Research

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 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]

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]

In a study involving 13 adults with autism spectrum disorder (ASD) and major depressive disorder (MDD), repetitive transcranial magnetic stimulation (rTMS) was found to be well tolerated, with mild side effects reported.

Participants experienced a significant reduction in depressive symptoms, with an average improvement of 13.5 points on the Hamilton rating scale for depression, and 40% achieved remission, suggesting rTMS may be an effective treatment for depression in individuals with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Adults with Autism and Major Depressive Disorder Using Transcranial Magnetic Stimulation: An Open Label Pilot Study. Gwynette, MF., Lowe, DW., Henneberry, EA., 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 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]

Repetitive transcranial magnetic stimulation (rTMS) is a powerful tool that can effectively treat clinical depression and potentially other brain disorders, but it carries risks, including the potential to induce seizures, as evidenced by 7 known cases by 1996.

A workshop established safety guidelines for rTMS, emphasizing the importance of monitoring, ethical considerations, and the expertise required for its administration to minimize risks and enhance therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Wassermann, EM.[2022]

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.

The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Kim, WS., Paik, NJ.[2023]

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

2. England pubmed.ncbi.nlm.nih.gov

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

3. Germany pubmed.ncbi.nlm.nih.gov

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

4. 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]

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

Treatment of Adults with Autism and Major Depressive Disorder Using Transcranial Magnetic Stimulation: An Open Label Pilot Study. [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. United States pubmed.ncbi.nlm.nih.gov

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

8. Ireland pubmed.ncbi.nlm.nih.gov

Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. [2022]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]

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

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