TMS for Autism
Recruiting in Palo Alto (17 mi)
Overseen byJames McPartland, PhD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Yale University
Must not be taking: Cognitive-affecting drugs
Disqualifiers: Head trauma, Psychiatric illness, Seizures, others
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This is a randomized interventional study designed to evaluate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on neural and behavioral facets of social cognition in adults with autism spectrum disorder (ASD).
Will I have to stop taking my current medications?
Yes, if you are taking prescription medications that may affect cognitive processes, you will need to stop taking them to participate in this trial.
What data supports the effectiveness of the treatment Transcranial Magnetic Stimulation (TMS) for autism?
Research shows that TMS can improve cognitive outcomes and reduce certain symptoms in people with autism. Studies also suggest that TMS may help with motor function and behavioral improvements, making it a promising treatment option for autism.
12345Is TMS safe for use in humans?
TMS, including its variations like theta burst stimulation (TBS), is generally considered safe for humans, with most adverse events being mild. However, there is a slight risk of seizures, and caution is advised, especially with newer protocols like TBS.
26789How is the treatment TMS for autism different from other treatments?
TMS (Transcranial Magnetic Stimulation) is unique because it is a non-invasive brain stimulation technique that uses magnetic fields to improve brain function, unlike traditional drug treatments. It specifically targets areas of the brain associated with autism symptoms, potentially improving social communication and cognitive outcomes without the need for medication.
1251011Eligibility Criteria
This trial is for adults aged 18-40 with autism spectrum disorder (ASD) or typical development, able to undergo EEG and eye-tracking tests. It excludes those with major psychiatric illnesses, pregnant women, individuals with an IQ below 80, history of seizures or serious medical conditions, recent drug/alcohol use, prior TMS therapy or investigational drug use within the last 12 weeks.Inclusion Criteria
Individuals able to participate in an EEG and eye-tracking experiment
I am between 18 and 40 years old, with or without autism.
Exclusion Criteria
Participants who have taken alcohol or recreational drugs within the preceding 24 hours
Participants reporting significant head trauma or serious brain illness
Participants with an IQ (intelligence quotient) below 80
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Baseline assessment of neuropsychological, cognitive, and behavioral function
1 day
1 visit (in-person)
Treatment
Participants receive either real or sham rTMS and undergo EEG and eye-tracking to measure neural and visual attentional social response
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain. The goal is to see how rTMS affects social cognition in adults with ASD.
2Treatment groups
Active Control
Placebo Group
Group I: Transcranial Magnetic Stimulation - realActive Control1 Intervention
Participants will receive active TMS during their study visit
Group II: Transcranial Magnetic Stimulation - shamPlacebo Group1 Intervention
Participants will receive sham stimulation during their study visit simulating TMS
Transcranial Magnetic Stimulation (TMS) is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Transcranial Magnetic Stimulation (TMS) for:
- Major Depressive Disorder (MDD)
- Obsessive-Compulsive Disorder (OCD)
- Migraine Headache Symptoms
🇪🇺 Approved in European Union as Transcranial Magnetic Stimulation (TMS) for:
- Major Depressive Disorder (MDD)
- Obsessive-Compulsive Disorder (OCD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Yale University Child Study CenterNew Haven, CT
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Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
United States Department of DefenseCollaborator
References
Treatment Response of Transcranial Magnetic Stimulation in Intellectually Capable Youth and Young Adults with Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. [2023]To examine current clinical research on the use of transcranial magnetic stimulation (TMS) in the treatment of pediatric and young adult autism spectrum disorder in intellectually capable persons (IC-ASD). We searched peer-reviewed international literature to identify clinical trials investigating TMS as a treatment for behavioral and cognitive symptoms of IC-ASD. We identified sixteen studies and were able to conduct a meta-analysis on twelve of these studies. Seven were open-label or used neurotypical controls for baseline cognitive data, and nine were controlled trials. In the latter, waitlist control groups were often used over sham TMS. Only one study conducted a randomized, parallel, double-blind, and sham controlled trial. Favorable safety data was reported in low frequency repetitive TMS, high frequency repetitive TMS, and intermittent theta burst studies. Compared to TMS research of other neuropsychiatric conditions, significantly lower total TMS pulses were delivered in treatment and neuronavigation was not regularly utilized. Quantitatively, our multivariate meta-analysis results report improvement in cognitive outcomes (pooled Hedges' g = 0.735, 95% CI = 0.242, 1.228; p = 0.009) and primarily Criterion B symptomology of IC-ASD (pooled Hedges' g = 0.435, 95% CI = 0.359, 0.511; p
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.
Transcranial Magnetic Stimulation in Autism Spectrum Disorders: Neuropathological Underpinnings and Clinical Correlations. [2021]Despite growing knowledge about autism spectrum disorder (ASD), research findings have not been translated into curative treatment. At present, most therapeutic interventions provide for symptomatic treatment. Outcomes of interventions are judged by subjective endpoints (eg, behavioral assessments) which alongside the highly heterogeneous nature of ASD account for wide variability in the effectiveness of treatments. Transcranial magnetic stimulation (TMS) is one of the first treatments that targets a putative core pathologic feature of autism, specifically the cortical inhibitory imbalance that alters gamma frequency synchronization. Studies show that low frequency TMS over the dorsolateral prefrontal cortex of individuals with ASD decreases the power of gamma activity and increases the difference between gamma responses to target and nontarget stimuli. TMS improves executive function skills related to self-monitoring behaviors and the ability to apply corrective actions. These improvements manifest themselves as a reduction of stimulus bound behaviors and diminished sympathetic arousal. Results become more significant with increasing number of sessions and bear synergism when used along with neurofeedback. When applied at low frequencies in individuals with ASD, TMS appears to be safe and to improve multiple patient-oriented outcomes. Future studies should be conducted in large populations to establish predictors of outcomes (eg, genetic profiling), length of persistence of benefits, and utility of booster sessions.
Effects of low frequency repetitive transcranial magnetic stimulation (rTMS) on gamma frequency oscillations and event-related potentials during processing of illusory figures in autism. [2022]Previous studies by our group suggest that the neuropathology of autism is characterized by a disturbance of cortical modularity. In this model a decrease in the peripheral neuropil space of affected minicolumns provides for an inhibitory deficit and a readjustment in their signal to noise bias during information processing. In this study we proposed using low frequency transcranial magnetic stimulation (rTMS) as a way increasing the surround inhibition of minicolumns in autism. Thirteen patients (ADOS and ADI-R diagnosed) and equal number of controls participated in the study. Repetitive TMS was delivered at 0.5 Hz, 2 times per week for 3 weeks. Outcome measures based on event-related potentials (ERP), induced gamma activity, and behavioral measures showed significant post-TMS improvement. The results suggest that rTMS offers a potential therapeutic intervention for autism.
Repetitive transcranial magnetic stimulation (rTMS) improves movement-related cortical potentials in autism spectrum disorders. [2022]Motor impairments are common in autism spectrum disorders (ASD). Electrophysiologic studies reveal abnormalities in the preparation of movement; repetitive transcranial magnetic stimulation (rTMS) to key motor cortical sites may therefore be a useful technique for improving motor function in ASD.
Prevalence of Adverse Effects Associated With Transcranial Magnetic Stimulation for Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. [2022]A growing number of studies have suggested that transcranial magnetic stimulation (TMS) may represent a novel technique with both investigative and therapeutic potential for autism spectrum disorder (ASD). However, a full spectrum of the adverse effects (AEs) of TMS used in ASD has not been specifically and systematically evaluated.
Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. [2022]Theta burst stimulation (TBS) protocols have recently emerged as a method to transiently alter cortical excitability in the human brain through repetitive transcranial magnetic stimulation. TBS involves applying short trains of stimuli at high frequency repeated at intervals of 200 milliseconds. Because repetitive transcranial magnetic stimulation is known to carry a risk of seizures, safety guidelines have been established. TBS has the theoretical potential of conferring an even higher risk of seizure than other repetitive transcranial magnetic stimulation protocols because it delivers high-frequency bursts. In light of the recent report of a seizure induced by TBS, the safety of this new protocol deserves consideration. We performed an English language literature search and reviewed all studies published from May 2004 to December 2009 in which TBS was applied. The adverse events were documented, and crude risk was calculated. The majority of adverse events attributed to TBS were mild and occurred in 5% of subjects. Based on this review, TBS seems to be a safe and efficacious technique. However, given its novelty, it should be applied with caution. Additionally, this review highlights the need for rigorous documentation of adverse events associated with TBS and intensity dosing studies to assess the seizure risk associated with various stimulation parameters (e.g., frequency, intensity, and location).
Safety of transcranial magnetic stimulation in Parkinson's disease: a review of the literature. [2021]Transcranial magnetic stimulation (TMS) has been used in both physiological studies and, more recently, the therapy of Parkinson's disease (PD). Prior TMS studies in healthy subjects and other patient populations demonstrate a slight risk of seizures and other adverse events. Our goal was to estimate these risks and document other safety concerns specific to PD patients.
Safety and tolerability of theta burst stimulation vs. single and paired pulse transcranial magnetic stimulation: a comparative study of 165 pediatric subjects. [2020]Although single- and paired-pulse (sp/pp) transcranial magnetic stimulation (TMS) studies are considered minimal risk in adults and children, the safety profile for theta-burst TMS (TBS) is unknown.
Autism spectrum disorders: linking neuropathological findings to treatment with transcranial magnetic stimulation. [2015]Postmortem studies in autism spectrum disorder (ASD) individuals indicate the presence of abnormalities within the peripheral neuropil space (PNS) of cortical minicolumns. The geometrical orientation of inhibitory elements within the PNS suggests using repetitive transcranial magnetic stimulation (rTMS) to up-regulate their activity. Several rTMS trials in ASD have shown marked improvements in motor symptomatology, attention and perceptual binding.
Repetitive transcranial magnetic stimulation (rTMS) in autism spectrum disorder: protocol for a multicentre randomised controlled clinical trial. [2021]There are no well-established biomedical treatments for the core symptoms of autism spectrum disorder (ASD). A small number of studies suggest that repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, may improve clinical and cognitive outcomes in ASD. We describe here the protocol for a funded multicentre randomised controlled clinical trial to investigate whether a course of rTMS to the right temporoparietal junction (rTPJ), which has demonstrated abnormal brain activation in ASD, can improve social communication in adolescents and young adults with ASD.