Transauricular Vagus Nerve Stimulation for Autism Spectrum Disorder
Recruiting in Palo Alto (17 mi)
Overseen byXiaolong Peng
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical University of South Carolina
Must not be taking: Olanzapine, Chlorpromazine, Lithium
Disqualifiers: Seizure, Epilepsy, Psychosis, Mania, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to explore whether a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) can manage symptoms in patients with autism spectrum disorder (ASD). Additionally, this study also uses magnetic resonance imaging (MRI) to capture images of participants' brains and apply an image processing method called INSCAPE to track brain state changes during taVNS treatment in ASD. Investigators will recruit up to 16 participants with ASD.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using medications that lower the seizure threshold, like olanzapine, chlorpromazine, or lithium.
What data supports the effectiveness of this treatment for autism spectrum disorder?
Research suggests that stimulating the vagus nerve, which is a nerve that connects the brain to the body, may help with mood and social communication in people with autism. This type of treatment has shown promise in helping with related conditions like epilepsy and depression, which often occur alongside autism.
12345Is transauricular vagus nerve stimulation (taVNS) safe for humans?
Transauricular vagus nerve stimulation (taVNS) is generally considered safe, with mild and temporary side effects like ear pain, headache, and tingling. A systematic review found no severe adverse events linked to taVNS, and the risk of side effects was similar to those not receiving the treatment.
13678How is transauricular vagus nerve stimulation different from other treatments for autism spectrum disorder?
Transauricular vagus nerve stimulation (taVNS) is unique because it is a non-invasive treatment that targets the vagus nerve through the ear to potentially improve symptoms of autism spectrum disorder (ASD). Unlike traditional treatments, taVNS may help regulate mood and social communication by activating specific brain regions and modulating the neuroimmune system, offering benefits for both core ASD symptoms and related conditions like epilepsy and depression.
124910Eligibility Criteria
This trial is for English-speaking individuals aged 12-17 with a prior diagnosis of Autism Spectrum Disorder (ASD) confirmed by ADOS. Participants must be able to give their own assent, while consent will be provided by a legal guardian.Inclusion Criteria
I can agree to participate in the study myself, but my legal guardian will also give consent.
English speaking
Prior diagnosis of ASD using autism diagnostic observation schedule (ADOS)
+1 more
Exclusion Criteria
I am currently experiencing a severe flare-up of my lung condition or symptoms from COVID.
I or my family have a history of seizures, or I take medication that can lower my seizure threshold.
I have had recent facial or ear pain, or injury to my ear.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Baseline Evaluation and Training
Participants receive a baseline behavior evaluation and MRI scans, followed by training on self-administering taVNS
1 week
1 visit (in-person)
Treatment
Participants self-administer taVNS or sham stimulation at home twice daily for 4 weeks
4 weeks
At-home administration
Mid-treatment Evaluation
Participants complete a virtual behavioral evaluation after 2 weeks of treatment
1 day
1 visit (virtual)
Post-treatment Evaluation
Participants undergo post-treatment MRI scanning and behavioral evaluation
1 week
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with evaluations at 1 and 4 weeks post-treatment
4 weeks
2 visits (virtual)
Participant Groups
The study tests transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive ear stimulation, against sham stimulation to manage ASD symptoms. It includes MRI brain imaging to track changes during the taVNS treatment in participants.
2Treatment groups
Active Control
Placebo Group
Group I: Active Vagus Nerve StimulationActive Control1 Intervention
This active vagus nerve stimulation uses electrodes on the ear to be administered twice daily, seven days per week, for four weeks at-home.
Group II: Sham StimulationPlacebo Group1 Intervention
This sham nerve stimulation uses electrodes on the ear to be administered twice daily, seven days per week, for four weeks at-home.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
30 Bee StreetCharleston, SC
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Who Is Running the Clinical Trial?
Medical University of South CarolinaLead Sponsor
MUSC COBRE in Neurodevelopment and its Disorders (CNDD) Pilot Projects Program (PPP)Collaborator
References
Autistic spectrum disorder, epilepsy, and vagus nerve stimulation. [2022]In individuals with a comorbid autistic spectrum disorder and medically refractory epilepsy, vagus nerve stimulation may offer the potential of seizure control and a positive behavioral side effect profile. We aimed to examine the behavioral side effect profile using longitudinal and quantitative data and review the potential mechanisms behind behavioral changes.
Transcutaneous Vagus Nerve Stimulation: A Promising Method for Treatment of Autism Spectrum Disorders. [2020]Transcutaneous Vagus Nerve Stimulation (tVNS) on the auricular branch of the vagus nerve has been receiving attention due to its therapeutic potential for neuropsychiatric disorders. Although the mechanism of tVNS is not yet completely understood, studies have demonstrated the potential role of vagal afferent nerve stimulation in the regulation of mood and visceral state associated with social communication. In addition, a growing body of evidence shows that tVNS can activate the brain regions associated with Autism Spectrum Disorder (ASD), trigger neuroimmune modulation and produce treatment effects for comorbid disorders of ASD such as epilepsy and depression. We thus hypothesize that tVNS may be a promising treatment for ASD, not only for comorbid epilepsy and depression, but also for the core symptoms of ASD. The goal of this manuscript is to summarize the findings and rationales for applying tVNS to treat ASD and propose potential parameters for tVNS treatment of ASD.
Remotely supervised at-home delivery of taVNS for autism spectrum disorder: feasibility and initial efficacy. [2023]Transcutaneous auricular vagus nerve stimulation (taVNS) has potential clinical application for autism spectrum disorder (ASD). At-home sessions are necessary to allow delivery of repeated sessions, and remove burden on patients for daily visits, and reduce costs of clinic delivery. Our objective was to validate a protocol for remote supervised administration for home delivery of taVNS using specially designed equipment and platform.
Transcutaneous auricular vagus nerve stimulation therapy in patients with cognitively preserved structural focal epilepsy: A case series report. [2023]Transcutaneous auricular vagus nerve stimulation (taVNS) was performed in two patients suffering structural focal epilepsy with preserved intellectual ability to show the feasibility of taVNS for specific patient groups.
Vagus nerve stimulation therapy in patients with autism spectrum disorder and intractable epilepsy: results from the vagus nerve stimulation therapy patient outcome registry. [2022]The purpose of this study was to determine the effectiveness of vagus nerve stimulation (VNS) therapy on quality-of-life (QOL) variables among patients with both autism spectrum disorder (ASD) and persistent or recurrent intractable epilepsy.
Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]Transcutaneous auricular vagus nerve stimulation (taVNS) has been investigated as a novel neuromodulation tool. Although taVNS is generally considered safe with only mild and transient adverse effects (AEs), those specifically caused by taVNS have not yet been investigated. This systematic review and meta-analysis on taVNS aimed to (1) systematically analyze study characteristics and AE assessment, (2) characterize and analyze possible AEs and their incidence, (3) search for predictable risk factors, (4) analyze the severity of AE, and (5) suggest an evidence-based taVNS adverse events questionnaire for safety monitoring. The articles searched were published through April 7, 2022, in Medline, Embase, Web of Science, Cochrane, and Lilacs databases. In general, we evaluated 177 studies that assessed 6322 subjects. From these, 55.37% of studies did not mention the presence or absence of any AEs; only 24.86% of the studies described that at least one adverse event occurred. In the 35 studies reporting the number of subjects with at least one adverse event, a meta-analytic approach to calculate the risk differences of developing an adverse event between active taVNS and controls was used. The meta-analytic overall adverse events incidence rate was calculated for the total number of adverse events reported on a 100,000 person-minutes-days scale. There were no differences in risk of developing an adverse event between active taVNS and controls. The incidence of AE, in general, was 12.84/100,000 person-minutes-days of stimulation, and the most frequently reported were ear pain, headache, and tingling. Almost half of the studies did not report the presence or absence of any AEs. We attribute this to the absence of AE in those studies. There was no causal relationship between taVNS and severe adverse events. This is the first systematic review and meta-analysis of transcutaneous auricular stimulation safety. Overall, taVNS is a safe and feasible option for clinical intervention.
Effects of Stable Vagus Nerve Stimulation Efficacy on Autistic Behaviors in Ten Pediatric Patients With Drug Resistant Epilepsy: An Observational Study. [2023]Vagus nerve stimulation (VNS) is a safe and effective therapy for pediatric patients with drug-resistant epilepsy (DRE). However, in children with DRE, the effects of VNS on autistic behaviors remain controversial. We retrospectively collected data from 10 children with DRE who underwent VNS implantation and regular parameter regulation in three pediatric epilepsy centers, and completed the behavioral assessments, including the autistic behavior checklist and the child behavior checklist, at follow-ups 1 (mean 2.16 years) and 2 (mean 2.98 years). The 10 children maintained stable seizure control between the two follow-ups. Their autistic behaviors, especially in language, social and self-help, were reduced at follow-up 2 compared to follow-up 1 (p = 0.01, p = 0.01, respectively). Moreover, these improvements were not associated with their seizure control, whether it was positive or negative. These results suggested that the VNS had a positive effect on autistic behaviors, which provided a preliminary clinical basis that VNS may benefit to younger children with DRE comorbidity autism spectrum disorder (ASD).
Adverse events in children receiving intermittent left vagal nerve stimulation. [2019]The purpose of this study was to determine the frequency of unexpected events during intermittent vagal nerve stimulation in 24 patients stimulated for a total of 61 patient years. The charts of 24 children undergoing periodic stimulation of the left vagal nerve on research protocols were reviewed to determine the nature and frequency of adverse events and the total length of time they were stimulated. Fifteen adverse events were discovered in 12 patients. Thirteen were likely related to the device, and four other events might have been related. Two of these resulted in voluntary termination of vagal nerve stimulation, and the rest were treatable. Vagal nerve stimulation was tolerated in this series of patients. As opposed to the more standard drug therapies, adverse events during vagal nerve stimulation do not necessitate termination of therapy, but these events frequently lead to unforeseen surgery under general anesthesia.
Vagus nerve stimulation in neuropsychiatry: Targeting anatomy-based stimulation sites. [2018]The vagus nerve (VN) is the longest cranial nerve, extending from the brain to the abdominal cavity. The VN consists of both afferent and efferent fibers (respectively 80% and 20%). Vagus nerve stimulation (VNS) is a neuromodulation strategy first developed in the 1980s for epilepsy. More recently, growing efforts in clinical research have been underscoring possible clinical benefits of VNS for different medical conditions such as epilepsy, major depression, anxiety disorders, and Tourette syndrome. Following the rational of VN anatomy and cranial innervation presented above, we hereby hypothesize that transcutaneously placing electrodes over the mastoid process could be a useful study protocol for future tVNS trials.
Auricular transcutaneous vagus nerve stimulation improves memory persistence in naïve mice and in an intellectual disability mouse model. [2020]Vagus nerve stimulation (VNS) using non-invasive approaches have attracted great attention due to their anti-epileptic, anti-depressive and pro-cognitive effects. It has been proposed that auricular transcutaneous VNS (atVNS) could benefit intellectual disability disorders, but preclinical data supporting this idea is limited.