rTMS for Autism

((AMBLE Autism) Trial)

Overseen By Pushpal Desarkar, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Must not be taking: Benzodiazepines, Anticonvulsants

Disqualifiers: Pregnancy, Substance use disorder, others

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

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

Compensation: Varies

Number of Visits: 11

Duration: 1 week

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment option for autistic adults with motor function difficulties. Researchers use a technique called repetitive Transcranial Magnetic Stimulation (rTMS), which involves magnetic fields to stimulate specific brain areas, to determine if it can improve motor skills. Participants will receive either active rTMS or a sham version to compare effects. Adults with autism who face significant motor function challenges, have an IQ above 70, and are clinically stable may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options.

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

The trial does not specify if you need to stop all current medications, but you cannot participate if you are taking benzodiazepines or anticonvulsants.

What prior data suggests that rTMS is safe for autistic adults?

Past studies have used repetitive Transcranial Magnetic Stimulation (rTMS) to help people with autism. Research has shown that rTMS is generally well-tolerated, with most people experiencing no serious side effects. Some may experience mild headaches or dizziness after treatment, but these effects usually resolve quickly.

A review of studies found that rTMS could improve symptoms in people with autism without causing significant harm. This treatment is already used for other conditions, suggesting its safety. While individual experiences may vary, existing evidence reassures about the safety of rTMS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about rTMS (repetitive transcranial magnetic stimulation) for autism because it offers a new approach by using magnetic fields to stimulate nerve cells in the brain, specifically targeting the motor cortex. Unlike traditional therapies for autism, which often involve behavioral interventions or medications that manage symptoms, rTMS directly influences brain activity and connectivity, potentially addressing the neurological underpinnings of autism. This non-invasive method provides hope for more immediate effects on brain function, possibly leading to improvements in social and communication skills in autistic individuals.

What evidence suggests that rTMS might be an effective treatment for autism?

Research shows that repetitive Transcranial Magnetic Stimulation (rTMS) may help treat autism. Earlier studies used rTMS to target different brain areas, aiming to improve social skills in individuals with autism spectrum disorder (ASD). A review of these studies found that rTMS led to improvements in some autism symptoms, particularly in social interactions, which often pose challenges for people with autism. In this trial, participants will receive either active rTMS or sham rTMS to the motor cortex. Although more research is needed, these findings suggest that rTMS might also assist with certain motor skills and social behaviors in autistic adults. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with autism who have difficulties with motor functions. Participants should be able to give informed consent and follow the study procedures. Specific details about inclusion or exclusion criteria are not provided, but typically these would outline health conditions or medications that might disqualify someone from participating.

Inclusion Criteria

ASD or control participants agreeing to adhere to Lifestyle Considerations throughout study duration

ASD participants with DSM-5 diagnosis of ASD without intellectual disability confirmed by clinical assessment and ADOS-2

ASD or control participants able to read, write, and communicate effectively in English

Exclusion Criteria

ASD or control participants with significant hearing or visual impairment interfering with the ability to read or hear instructions

I have a medical condition that might need urgent care.

I am currently taking benzodiazepines or anticonvulsants for ASD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Clinical, adaptive, and motor function assessments, and pre- and post-iTBS session with EEG to assess plasticity

1 week

2 visits (in-person)

Treatment

Randomized, double-blind, sham-controlled rTMS sessions on the motor cortex

1 week

5 visits (in-person)

Immediate Post-Treatment Assessment

Assessment of motor and adaptive function, and plasticity in the motor cortex immediately after the last rTMS session

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in motor function and plasticity 1 and 4 weeks after the last rTMS session

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• rTMS

Trial Overview The study is examining if using repetitive Transcranial Magnetic Stimulation (rTMS) on the motor cortex can improve motor function in autistic adults by reducing hyperplasticity. There's a comparison between active rTMS and sham (placebo-like) treatment.

How Is the Trial Designed?

Group I: Active rTMS Active Control 1 Intervention

Autistic adults receiving active rTMS to the motor cortex.

Group II: Sham rTMS Placebo Group 1 Intervention

Autistic adults receiving sham rTMS to the motor cortex.

rTMS is already approved in United States, European Union for the following indications:

Approved in United States as rTMS for:

• Obsessive-Compulsive Disorder (OCD)
• Major Depressive Disorder
• Migraines
• Smoking cessation

Approved in European Union as rTMS for:

• Obsessive-Compulsive Disorder (OCD)
• Major Depressive Disorder

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

Published Research Related to This Trial

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 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 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]

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]

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]

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]

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 124 high-functioning children with autism spectrum disorders (ASD), repetitive transcranial magnetic stimulation (rTMS) significantly improved cognitive control and attention, particularly after 18 treatment sessions, as evidenced by enhanced accuracy and reaction times in a visual oddball task.

The treatment also led to notable reductions in aberrant behaviors and improvements in executive functions, suggesting that rTMS may effectively target core features of ASD with minimal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploratory Study of rTMS Neuromodulation Effects on Electrocortical Functional Measures of Performance in an Oddball Test and Behavioral Symptoms in Autism. Sokhadze, EM., Lamina, EV., Casanova, EL., et al.[2023]

Citations

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

Repetitive transcranial magnetic stimulation (rTMS) in autism ... A double-blind, randomized trial of deep repetitive transcranial magnetic stimulation (rTMS) for autism spectrum disorder. Brain Stimul 2014 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1935861X13002994

A Double-blind, Randomized Trial of Deep Repetitive ... The aim of this study was to examine whether deep rTMS to bilateral dorsomedial prefrontal cortex improves social relating in ASD.

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

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02311751

rTMS for Executive Function Deficits in Autism Spectrum ... This study is a randomized, double blind, sham controlled study to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS) as a treatment ...

6. 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.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04532424

Transcranial Magnetic Stimulation for Restricted and ... Investigating the efficacy of a form of TMS called theta-burst stimulation for restricted and repetitive behavior in ASD. Official Title. Transcranial Magnetic ...