Transcranial Magnetic Stimulation for Autism
(TMS for ASD Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byAntonio Y. Hardan, MD
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Must not be taking: Clozapine, others
Disqualifiers: Seizures, Pregnancy, Substance use, Bipolar, others
No Placebo Group
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.
12345Is 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.
12356How 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.
12357Eligibility 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)
+2 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Targeting stereotyped motor behaviorsExperimental Treatment1 Intervention
Group II: Targeting insistence on samenessExperimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford UniversityStanford, CA
Robin LiboveStanford, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
References
Intermittent theta-burst transcranial magnetic stimulation for autism spectrum disorder: an open-label pilot study. [2019]Theta-burst stimulation (TBS) modulates synaptic plasticity more efficiently than standard repetitive transcranial magnetic stimulation delivery and may be a promising modality for neuropsychiatric disorders such as autism spectrum disorder (ASD). At present there are few effective interventions for prefrontal cortex dysfunction in ASD. We report on an open-label, pilot study of intermittent TBS (iTBS) to target executive function deficits and restricted, repetitive behaviors in male children and adolescents with ASD.
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]Although previous open-label trials suggest the therapeutic potential of inhibitory repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (DLPFC) in autism spectrum disorder (ASD), methodological caveats exist. We conducted an 8-week randomized, double-blind sham-controlled trial to investigate the efficacy of inhibitory continuous theta burst stimulation (cTBS, a variant of rTMS) over the left DLPFC in individuals with ASD. Sixty children, adolescents and young adults (aged 8-30 years) with ASD without co-occurring intellectual disabilities were randomized to a 16-session 8-week cTBS versus sham stimulation course, with a follow-up 4 weeks after the trial. The Active group was not superior to the Sham group in any clinical or neuropsychological metrics at Week 8 or Week 12. Time effects of 8-week cTBS on symptoms and executive function were remarkable in both Active and Sham groups, with comparable response rates and effect sizes of changes in symptoms/cognition between groups. Our results from a sufficiently powered sample do not endorse the superior efficacy of cTBS over the left DLPFC to the shamed stimulation for children, adolescents and adults with ASD. These findings suggest that earlier positive open-label trial findings may be generalized by generalized/placebo effects. This highlights the urgent need for more rTMS/TBS studies with rigorous trial designs in ASD.
5-day multi-session intermittent theta burst stimulation over bilateral posterior superior temporal sulci in adults with autism-a pilot study. [2022]Theta burst stimulation (TBS), a patterned repetitive transcranial magnetic stimulation (rTMS) protocol with shorter simulation duration and lower stimulus intensity, could be a better protocol for individuals with autism spectrum disorder (ASD). Our study aimed to explore the impacts of intermittent TBS (iTBS) over the bilateral posterior superior temporal sulcus (pSTS) on intellectually able adults with ASD.
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]Label="LAY ABSTRACT">Intermittent theta burst stimulation is a varied form of repetitive transcranial magnetic non-invasive brain stimulation technique used to treat several neurological and psychiatric disorders. Its feasibility and therapeutic effects on the bilateral posterior superior temporal sulcus in children with autism are unknown. We conducted a single-blind, sham-controlled parallel randomized clinical trial in a hitherto largest sample of intellectually able children with autism (N = 78). Participants randomized to the active group received two-session/week intermittent theta burst stimulation for continuous 8 weeks. Those in the sham group received two-session/week sham stimulations in the first 4 weeks and then active intervention for the following 4 weeks after unblinding. First, we found that continuous 8-week intermittent theta burst stimulation on the bilateral posterior superior temporal sulcus in children with autism is safe and tolerable. Second, we found that 8-week intermittent theta burst stimulation produced greater therapeutic efficacy, although we did not find any significant effects of 4-week intermittent theta burst stimulation on core symptoms and social cognitive performances in autism. Further analysis revealed that participants with higher intelligence and better social cognitive performance, alongside less attention-deficit hyperactivity disorder severity at baseline, were more likely to be responders. This study identified that the factors contribute to responders and the results suggest that longer courses of non-invasive brain stimulation may be needed to produce therapeutic benefits in autism, with consideration of heterogeneous responses.
Abnormal modulation of corticospinal excitability in adults with Asperger's syndrome. [2022]Most candidate genes and genetic abnormalities linked to autism spectrum disorders (ASD) are thought to play a role in developmental and experience-dependent plasticity. As a possible index of plasticity, we assessed the modulation of motor corticospinal excitability in individuals with Asperger's syndrome (AS) using transcranial magnetic stimulation (TMS). We measured the modulatory effects of theta-burst stimulation (TBS) on motor evoked potentials (MEPs) induced by single-pulse TMS in individuals with AS as compared with age-, gender- and IQ-matched neurotypical controls. The effect of TBS lasted significantly longer in the AS group. The duration of the TBS-induced modulation alone enabled the reliable classification of a second study cohort of subjects as AS or neurotypical. The alteration in the modulation of corticospinal excitability in AS is thought to reflect aberrant mechanisms of plasticity, and might provide a valuable future diagnostic biomarker for the disease and ultimately offer a target for novel therapeutic interventions.
A Systematic Review of the Safety and Tolerability of Theta Burst Stimulation in Children and Adolescents. [2023]Theta burst stimulation (TBS) is often used in clinical practice and research protocols for adults with neuropsychiatric disorders. There are substantial knowledge gaps related to the application of TBS in children and adolescents. This systematic review examined the safety and tolerability of TBS in children and adolescents.
Modulation of motor cortical excitability by continuous theta-burst stimulation in adults with autism spectrum disorder. [2023]To test whether change in motor evoked potential (ΔMEP) induced by continuous theta-burst stimulation (cTBS) of motor cortex (M1) distinguishes adults with autism spectrum disorder (ASD) from neurotypicals, and to explore the contribution of two common polymorphisms related to neuroplasticity.