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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of repetitive transcranial magnetic stimulation (rTMS) for children with autism who struggle with self-regulation, which involves managing emotions and behaviors. rTMS is a non-invasive treatment that uses magnetic fields to stimulate brain activity. Participants will receive either real rTMS sessions or a sham version to compare effects. Children with autism who have self-regulation difficulties and can safely undergo rTMS might be suitable candidates. The goal is to determine if rTMS can improve self-regulation in these children. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group.

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 prior data suggests that repetitive transcranial magnetic stimulation (rTMS) is safe for individuals with Autism Spectrum Disorder?

Research suggests that repetitive transcranial magnetic stimulation (rTMS) could help people with autism spectrum disorder (ASD). Some studies have found that it may improve symptoms like social communication. Regarding safety, rTMS is usually well-tolerated. A few studies on children showed positive effects without major problems. However, research on its safety is still ongoing. While some clinical programs use rTMS for ASD, more information is needed to fully understand its safety. So far, it appears to be a safe option with potential benefits for those with ASD. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for autism?

Unlike typical treatments for autism that often rely on behavioral therapies and medications to manage symptoms, repetitive transcranial magnetic stimulation (rTMS) offers a unique approach by using magnetic fields to stimulate nerve cells in the brain. This non-invasive technique has the potential to directly influence brain activity, which researchers hope could lead to improvements in social and communication skills. The promise of rTMS lies in its ability to target specific brain regions without the side effects often associated with medication, making it an exciting area of exploration for autism treatment.

What evidence suggests that rTMS is effective for autism?

Research has shown that repetitive Transcranial Magnetic Stimulation (rTMS), one of the treatments studied in this trial, can assist individuals with Autism Spectrum Disorder (ASD). Studies have found that rTMS significantly improves key symptoms, such as difficulties with social communication. In some cases, these improvements lasted up to six months. This treatment uses magnetic fields to stimulate brain cells, potentially aiding self-control and other ASD symptoms. Early results are promising and suggest that rTMS could be a useful tool for managing ASD. Participants in this trial will receive either rTMS or sham stimulation to further evaluate the effectiveness of rTMS. ^{1 4 5 6 7}

Who Is on the Research Team?

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

Principal Investigator

Holland Bloorview Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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) 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 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 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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8264904/

Repetitive transcranial magnetic stimulation (rTMS) in autism ... The health outcomes ... A double-blind, randomized trial of deep repetitive transcranial magnetic stimulation (rTMS) for autism spectrum disorder.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024077776

Assessing the impact of repetitive transcranial magnetic ... TMS-EEG data were acquired from 12 children diagnosed with ASD both before and following rTMS treatment. The rTMS intervention regimen included ...

3. 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.

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

Repetitive transcranial magnetic stimulation in children and ... Other studies indicate that rTMS can lead to significant improvements in core symptoms of ASD, such as social communication deficits, ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30038561/

Repetitive Transcranial Magnetic Stimulation for Treatment ... Only 5 studies reported stability of these gains for periods of up 6 months, with descriptions that improvements were sustained over time.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36367616/

Outcomes from Individual Alpha Frequency Guided ... This study presents evidence on the efficacy and safety of α-rTMS in improving ASD symptoms, quality of life and comorbid sleep troubles in children.

7. 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.