Transcranial Magnetic Stimulation for Autism
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Christiana Care Health Services
Disqualifiers: Significant anxiety, Seizures, Metallic implants, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
There is no consensus regarding the neurological substrate underpinning ASD. The investigators describe the novel concept of "social reciprocity network" and hypothesize that aberrant connectivity/oscillatory patterns affecting this network contribute to the core deficits in ASD. The overarching goal of this trial is to explore abnormalities involving the neuronal connectivity and oscillatory patterns within the social reciprocity network and to elucidate the role of modulating this network via rTMS in improving the above measures and social cognition in ASD. Quantitative electroencephalography (QEEG) coherence and spectral power analysis are reliable measures of neuronal connectivity and dynamics. The investigators aim to study the QEEG coherence/spectral power analysis to explore the neuronal dynamics affecting the social reciprocity network in ASD.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Transcranial Magnetic Stimulation for Autism?
How does transcranial magnetic stimulation treatment differ from other treatments for autism?
Transcranial magnetic stimulation (TMS) is unique because it targets a core issue in autism, the imbalance in brain activity, by using magnetic fields to stimulate specific brain areas. Unlike other treatments that focus on symptoms, TMS aims to improve brain function directly, potentially leading to better self-control and reduced repetitive behaviors.23678
Eligibility Criteria
This trial is for individuals with Autism Spectrum Disorder (ASD) at level 1 or 2, meaning they have some difficulties with social communication and may exhibit repetitive behaviors. Participants should not have a history of epilepsy or seizures and must not have any metallic devices in their head or neck.Inclusion Criteria
ASD level 1 or 2
Exclusion Criteria
Presence of metallic devices in the head or neck
I have a history of epilepsy or seizures.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Phase 1 (Sham Comparator)
Half of the subjects receive rTMS, while the other half receive sham stimulation
3 weeks
Phase 2 (Active Comparator)
All subjects receive active rTMS stimulation
3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 weeks
Treatment Details
Interventions
- Transcranial Magnetic Stimulation (Neurostimulation)
Trial OverviewThe study is testing the effects of transcranial magnetic stimulation (rTMS) on the 'social reciprocity network'—a proposed area of the brain involved in social interaction—in people with ASD. It aims to see if rTMS can improve connectivity within this network and enhance social cognition by using QEEG coherence/spectral power analysis.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: phase 2Active Control1 Intervention
During phase II (3 weeks) all subjects will receive active stimulation.
Group II: phase 1Placebo Group1 Intervention
During phase I (3 weeks), half of the subjects will receive rTMS, while the other half will receive sham stimulation.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Christiana CareNewark, DE
Loading ...
Who Is Running the Clinical Trial?
Christiana Care Health ServicesLead Sponsor
References
Repetitive Transcranial Magnetic Stimulation (rTMS) Modulates Event-Related Potential (ERP) Indices of Attention in Autism. [2021]Individuals with autism spectrum disorder (ASD) have previously been shown to have significantly augmented and prolonged event-related potentials (ERP) to irrelevant visual stimuli compared to controls at both early and later stages (e.g., N200, P300) of visual processing and evidence of an overall lack of stimulus discrimination. Abnormally large and indiscriminative cortical responses to sensory stimuli may reflect cortical inhibitory deficits and a disruption in the excitation/inhibition ratio. Low-frequency (≤1HZ) repetitive transcranial magnetic stimulation (rTMS) has been shown to increase inhibition of stimulated cortex by the activation of inhibitory circuits. It was our prediction that after 12 sessions of low-frequency rTMS applied bilaterally to the dorsolateral prefrontal cortices in individuals with ASD there would be a significant improvement in ERP indices of selective attention evoked at later (i.e., 200-600 ms) stages of attentional processing as well as an improvement in motor response error rate. We assessed 25 participants with ASD in a task of selective attention using illusory figures before and after 12 sessions of rTMS in a controlled design where a waiting-list group of 20 children with ASD performed the same task twice. We found a significant improvement in both N200 and P300 components as a result of rTMS as well as a significant reduction in response errors. We also found significant reductions in both repetitive behavior and irritability according to clinical behavioral questionnaires as a result of rTMS. We propose that rTMS has the potential to become an important therapeutic tool in ASD research and treatment.
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 1Hz repetitive transcranial magnetic stimulation on autism with intellectual disability: A pilot study. [2022]To explore whether 1 Hz repetitive transcranial magnetic stimulation (rTMS) has positive effects on brain activity and behavior of autistic children with intellectual disability.
Effects of repetitive transcranial magnetic stimulation in performing eye-hand integration tasks: four preliminary studies with children showing low-functioning autism. [2015]This report, based on four studies with children with low-functioning autism, aimed at evaluating the effects of repetitive transcranial magnetic stimulation delivered on the left and right premotor cortices on eye-hand integration tasks; defining the long-lasting effects of high-frequency repetitive transcranial magnetic stimulation; and investigating the real efficacy of high-frequency repetitive transcranial magnetic stimulation by comparing three kinds of treatments (high-frequency repetitive transcranial magnetic stimulation, a traditional eye-hand integration training, and both treatments combined). Results showed a significant increase in eye-hand performances only when high-frequency repetitive transcranial magnetic stimulation was delivered on the left premotor cortex; a persistent improvement up to 1 h after the end of the stimulation; better outcomes in the treatment combining high-frequency repetitive transcranial magnetic stimulation and eye-hand integration training. Based on these preliminary findings, further evaluations on the usefulness of high-frequency repetitive transcranial magnetic stimulation in rehabilitation of children with autism are strongly recommended.
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
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.
A combined study of MEG and pico-Tesla TMS on children with autism disorder. [2017]Magnetoencephalographic (MEG) recordings from the brain of 10 children with autism (6 boys and 4 girls, with ages range from 5-12 years, mean[Formula: see text][Formula: see text][Formula: see text]SD: 8.3[Formula: see text][Formula: see text][Formula: see text]2.1) were obtained using a whole-head 122-channel MEG system in a magnetically shielded room of low magnetic noise. A double-blind experimental design was used in order to look for possible effect of external pico-Tesla Transcranial Magnetic Stimulation (pT-TMS). The pT-TMS was applied on the brain of the autistic children with proper field characteristics (magnetic field amplitude: 1-7.5[Formula: see text]pT, frequency: the alpha - rhythm of the patient 8-13[Formula: see text]Hz). After unblinding it was found a significant effect of an increase of frequencies in the range of 2-7[Formula: see text]Hz across the subjects followed by an improvement and normalization of their MEG recordings. The statistical analysis of our results showed a statistical significance at 6 out of 10 patients (60%). It is also observed an increase of alpha activity in autistic children at the end of one month after pT-TMS treatment at home. In conclusion, the application of pT-TMS has the prospective to be a noninvasive, safe and important modality in the management of autism children.
Effects of repetitive transcranial magnetic stimulation on children with low-function autism. [2021]Autism spectrum disorder (ASD) is a very complex neurodevelopmental disorder, characterized by social difficulties and stereotypical or repetitive behavior. Some previous studies using low-frequency repetitive transcranial magnetic stimulation (rTMS) have proven of benefit in ASD children.