Transcranial Magnetic Stimulation for Autism

(TMS for ASD Trial)

Recruiting at 1 trial location

Overseen By Briana Hernandez

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Clozapine, others

Disqualifiers: Seizures, Pregnancy, Substance use, Bipolar, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

67 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special type of brain stimulation, called theta-burst stimulation (a form of transcranial magnetic stimulation), can reduce specific behaviors in people with Autism Spectrum Disorder (ASD). The focus is on behaviors such as a strong need for sameness and repetitive movements. Ideal participants are those with ASD who frequently experience repetitive behaviors or a strong insistence on sameness. This trial might be a good opportunity for those fitting this description to explore new treatment options. As an unphased trial, it offers a unique chance to contribute to groundbreaking research and potentially benefit from innovative treatment strategies.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop all current medications, but you cannot be taking Clozapine or any medication that the investigator thinks might increase the risk of TMS or affect its effectiveness.

What prior data suggests that theta-burst stimulation is safe for autism?

Research has shown that theta-burst stimulation (TBS) is generally safe for individuals with autism spectrum disorder (ASD). Studies have found that side effects, such as headaches or discomfort at the treatment site, are common but usually mild and not unique to the treatment itself.

A review indicates that TBS is as safe for children with ASD as it is for adults. Although more long-term studies are needed, current results are encouraging. Specifically, one study found that even when TBS is administered in high doses over several days, it remains safe and well-tolerated in children with ASD.

Overall, TBS appears to be a safe treatment option, with only mild and manageable side effects reported so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Theta-burst stimulation (TBS) is unique because it offers a non-invasive approach to managing autism symptoms by directly targeting brain activity using magnetic fields. Unlike many standard treatments for autism, which often involve behavioral therapies and medications, TBS aims to modulate neural circuits associated with specific behaviors, like insistence on sameness and stereotyped motor behaviors. Researchers are excited about TBS because it has the potential to precisely target and adjust brain functions in a way that could lead to more tailored and immediate improvements in symptoms, offering a promising alternative to more generalized treatments.

What evidence suggests that theta-burst stimulation is effective for restricted and repetitive behavior in autism?

Research suggests that theta-burst stimulation (TBS) might improve symptoms in people with autism spectrum disorder (ASD). In this trial, participants will receive TBS targeting either insistence on sameness or stereotyped motor behaviors. Some studies have found that TBS can boost social skills in children with autism who speak very little and have few treatment options. Personalized TBS has been particularly helpful in enhancing these skills. However, not all studies have shown major changes, such as in brain structure, after TBS treatment. Overall, early findings indicate that TBS could assist with certain autism-related behaviors, but more research is needed to fully understand its effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Antonio Y. Hardan, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals aged 12-45 with a diagnosis of Autism Spectrum Disorder, Asperger's or Autism. They must have tried at least two treatments without success or tolerance and be assessed using ADOS-2, CARS/BOSA (remotely), or ADI-R. A reliable informant must be available to complete questionnaires.

Inclusion Criteria

I am between 12 and 45 years old.

I have been diagnosed with Autism Spectrum Disorder, Asperger's, or Autism.

Meet criteria for ASD on clinical assessments (ADOS-2 or CARS/BOSA if conducted remotely & ADI-R)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive theta-burst stimulation targeting restricted and repetitive behavior in ASD

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Theta-burst Stimulation

Trial Overview The study tests theta-burst stimulation, a type of Transcranial Magnetic Stimulation (TMS), to see if it can reduce restricted and repetitive behaviors in those with ASD.

How Is the Trial Designed?

Group I: Targeting stereotyped motor behaviors Experimental Treatment 1 Intervention

Group II: Targeting insistence on sameness Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

In a pilot study involving 10 male children and adolescents with autism spectrum disorder (ASD), intermittent theta-burst stimulation (iTBS) showed promising improvements in executive function and repetitive behaviors after 15 treatment sessions over 3 weeks.

The iTBS treatment was well tolerated with no serious adverse effects reported, indicating its potential safety as a therapeutic option for addressing cognitive deficits in ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent theta-burst transcranial magnetic stimulation for autism spectrum disorder: an open-label pilot study. Abujadi, C., Croarkin, PE., Bellini, BB., et al.[2019]

The change in motor evoked potential (ΔMEP) measured 15 minutes after continuous theta-burst stimulation (cTBS) of the motor cortex is a significant biomarker that can help distinguish adults with autism spectrum disorder (ASD) from neurotypical individuals, based on a study involving 91 participants.

The effectiveness of ΔMEP as a diagnostic tool is influenced by specific genetic polymorphisms related to neuroplasticity, particularly the brain-derived neurotrophic factor (BDNF) and apolipoprotein E (APOE) genes, suggesting that genetic factors may play a role in the neurophysiological responses observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of motor cortical excitability by continuous theta-burst stimulation in adults with autism spectrum disorder. Jannati, A., Ryan, MA., Block, G., et al.[2023]

Individuals with Asperger's syndrome (AS) showed a significantly longer duration of motor corticospinal excitability modulation after theta-burst stimulation (TBS) compared to neurotypical controls, indicating differences in brain plasticity mechanisms.

This altered modulation could serve as a potential diagnostic biomarker for AS and may help in developing new therapeutic interventions targeting these plasticity mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abnormal modulation of corticospinal excitability in adults with Asperger's syndrome. Oberman, L., Eldaief, M., Fecteau, S., et al.[2022]

Intermittent theta burst stimulation is safe and tolerable for children with autism, as shown in a clinical trial with 78 participants over 8 weeks.

The treatment demonstrated greater therapeutic efficacy after 8 weeks, particularly in children with higher intelligence and better social cognitive skills, suggesting that longer stimulation courses may be necessary for optimal benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent theta burst stimulation over the posterior superior temporal sulcus for children with autism spectrum disorder: A 4-week randomized blinded controlled trial followed by another 4-week open-label intervention. Ni, HC., Chen, YL., Chao, YP., et al.[2021]

In a pilot study involving 13 adults with autism spectrum disorder (ASD), intermittent theta burst stimulation (iTBS) applied over the bilateral posterior superior temporal sulcus (pSTS) showed significant immediate improvements in parent-rated autistic symptoms after 5 days of treatment.

The effectiveness of iTBS on cognitive flexibility and clinical symptoms was influenced by individual factors such as baseline social-communicative impairment, cognitive performance, and concurrent psychotropic medication use, highlighting the need for personalized approaches in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

5-day multi-session intermittent theta burst stimulation over bilateral posterior superior temporal sulci in adults with autism-a pilot study. Ni, HC., Lin, HY., Chen, YL., et al.[2022]

In a well-designed 8-week randomized, double-blind sham-controlled trial involving 60 participants with autism spectrum disorder (ASD), inhibitory continuous theta burst stimulation (cTBS) did not show superior efficacy compared to sham stimulation in improving clinical or neuropsychological outcomes.

Both the active and sham groups exhibited similar improvements over time, suggesting that previous positive results from open-label trials may be influenced by placebo effects, indicating a need for more rigorous studies on rTMS/TBS in ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A lack of efficacy of continuous theta burst stimulation over the left dorsolateral prefrontal cortex in autism: A double blind randomized sham-controlled trial. Ni, HC., Chen, YL., Chao, YP., et al.[2023]

Theta burst stimulation (TBS) appears to be safe and tolerable for children and adolescents, with reported adverse events mostly being mild, such as headaches, similar to those seen in adults.

Despite the promising safety profile, there is a lack of long-term studies on TBS in younger populations, highlighting the need for further research to better understand its effects and potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of the Safety and Tolerability of Theta Burst Stimulation in Children and Adolescents. Elmaghraby, R., Sun, Q., Ozger, C., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40230821/

study protocol for a pilot randomized sham-controlled trial This trial will evaluate the feasibility, safety, and efficacy of high-dose iTBS treatment in children with ASD.

2. med.stanford.edu med.stanford.edu/content/dam/sm/scsnl/documents/xiao_Et_al_2025.pdf

Personalized Theta Burst Stimulation Enhances Social Skills ... ABSTRACT. BACKGROUND: Minimally verbal children with autism are understudied and lack effective treatment options.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06670040

Theta Burst Stimulation for Refractory Depression in Autism ... The overall goal of this study is to treat major depressive disorder (MDD) rapidly and effectively in individuals with autism spectrum disorder (ASD).

4. sciencedirect.com sciencedirect.com/science/article/pii/S221315822300013X

Lack of effects of four-week theta burst stimulation on white ... No significant white matter changes following 8-week iTBS over bilateral pSTS in ASD. Symptom changes do not correlate with white matter metrics following 4- ...

5. nature.com nature.com/articles/s41598-025-11540-7

Effects of ball combination training program ... This study aims to investigate the effects of a 12-week ball combination training program (BCTP) combined with continuous theta burst stimulation (cTBS) on MD ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11995711/

Feasibility, safety, and efficacy of high-dose intermittent ... We aim to preliminarily investigate the feasibility, safety, and efficacy of high-dose iTBS in children with autism spectrum disorder (ASD).

7. brainstimjrnl.com brainstimjrnl.com/article/S1935-861X(24)01238-5/fulltext

Safety and tolerability of intermittent theta burst ... These interim findings suggest that side effects from iTBS in autism are relatively common but are typically of mild severity and not specific to active ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8617062/

A Systematic Review of the Safety and Tolerability of Theta ... TBS interventions in children may have similar safety, tolerability, and feasibility as compared to adults. However, long-term, follow-up studies of TBS are ...

9. gpsych.bmj.com gpsych.bmj.com/content/38/2/e102012

Evaluating the feasibility, safety and efficacy of accelerated ... In this study, we conducted an open-label trial to assess the feasibility, safety and efficacy of the novel 5-day a-cTBS intervention among children with ASD.

10. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925001497

Theta-Burst Stimulation of the Right Temporoparietal ... These results also suggest clinical implications for using TBS to address social deficits in individuals with ASD and contribute to the safety ...