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: 0

Duration: 4 weeks

67 Participants Needed

Trial Summary

What is the purpose of this trial?

Investigating the efficacy of a form of TMS called theta-burst stimulation for restricted and repetitive behavior in ASD.

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 data supports the effectiveness of the treatment Theta-burst Stimulation for Autism?

Research suggests that intermittent theta-burst stimulation (iTBS) may help improve symptoms in children with autism, especially when used over a longer period, as it showed greater therapeutic effects in an 8-week study. However, results can vary, and more studies are needed to confirm its effectiveness. ^{1 2 3 4 5}

Is transcranial magnetic stimulation safe for humans, including those with autism?

Research on transcranial magnetic stimulation (TMS), including theta-burst stimulation (TBS), suggests it is generally safe for humans, including those with autism. Studies have explored its use in both adults and children with autism, and a systematic review has examined its safety in children and adolescents, indicating it is well-tolerated. ^{1 2 3 5 6}

How is the treatment Theta-burst Stimulation different from other treatments for autism?

Theta-burst Stimulation (TBS) is unique because it uses a specific pattern of magnetic pulses to modulate brain activity more efficiently than standard repetitive transcranial magnetic stimulation (rTMS). It targets brain areas involved in executive function and repetitive behaviors, which are often affected in autism, and is considered promising due to its shorter duration and lower intensity compared to other methods. ^{1 2 3 5 7}

Research Team

Antonio Y. Hardan, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Intermittent theta-burst transcranial magnetic stimulation for autism spectrum disorder: an open-label pilot study. [2019]

2. United States 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. [2023]

3. United States 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. [2022]

4. England 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. [2021]

5. France pubmed.ncbi.nlm.nih.gov

Abnormal modulation of corticospinal excitability in adults with Asperger's syndrome. [2022]

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

A Systematic Review of the Safety and Tolerability of Theta Burst Stimulation in Children and Adolescents. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Modulation of motor cortical excitability by continuous theta-burst stimulation in adults with autism spectrum disorder. [2023]