Vagus Nerve Stimulation for Anxiety in Autism

Overseen By Bashar Badran, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Olanzapine, Chlorpromazine, Lithium

Disqualifiers: Seizure, Epilepsy, Psychosis, Mania, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage anxiety in children with Autism Spectrum Disorder (ASD) using a device that stimulates a nerve in the ear, known as Transcutaneous auricular vagus nerve stimulation (taVNS). The goal is to determine if this wearable device, used at home, is safe and easy to use. Children aged 12-17 diagnosed with ASD and experiencing frequent anxiety may be suitable candidates. Participants will learn to use the device and apply it twice daily for four weeks without affecting their other treatments. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research that could enhance anxiety management in ASD.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot participate if you are using medications that substantially reduce seizure threshold, like olanzapine, chlorpromazine, or lithium.

What prior data suggests that transcutaneous auricular vagus nerve stimulation is safe for managing anxiety in individuals with Autism Spectrum Disorder?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe. Studies have found it to be a low-risk and simple treatment that targets the vagus nerve through the ear. It is non-invasive, requiring no surgery, and is affordable.

Most people using taVNS experience only mild side effects, such as ear pain, which typically resolve quickly. In past studies, participants used taVNS at home with remote guidance without major issues. This indicates that taVNS is well-tolerated and can be safely used independently, making it a promising option for managing conditions like anxiety in individuals with autism. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for anxiety in autism involve medications or behavioral therapies. However, transcutaneous auricular vagus nerve stimulation (taVNS) stands out because it uses a non-invasive device that stimulates the vagus nerve through the skin of the ear. This approach is exciting because it targets the body's nervous system directly, potentially reducing anxiety symptoms without the side effects often associated with medications. Additionally, the at-home use of taVNS offers a more accessible and flexible treatment option, which could improve the quality of life for individuals with autism and anxiety.

What evidence suggests that transcutaneous auricular vagus nerve stimulation is effective for anxiety in autism?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) could benefit people with autism spectrum disorder (ASD). Studies suggest that taVNS might enhance social understanding and interaction in individuals with ASD. Early findings also indicate that taVNS could help manage mood and reduce anxiety. It has been safely used at home, showing promise in easing anxiety and other symptoms. These initial results support further research into using taVNS as a treatment for anxiety in people with ASD. Participants in this trial will receive at-home taVNS to assess its impact on behavioral outcomes related to ASD and anxiety. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals aged 12-17 with Autism Spectrum Disorder (ASD) who also experience anxiety. They must have been previously diagnosed using the ADOS, score above 24 on the SCARED anxiety scale, and have an IQ over 70. Participants need to be able to give their own assent while consent will be provided by a legal guardian.

Inclusion Criteria

Prior diagnosis of ASD using autism diagnostic observation schedule (ADOS)

I can agree to participate in the study myself, but my legal guardian will also give consent.

English speaking

Exclusion Criteria

I am able to understand and participate in the consent process.

Pregnancy

I have had a heart attack or an irregular heartbeat.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Training

Participants receive in-person training on how to self-administer taVNS

1 visit

1 visit (in-person)

Treatment

Participants self-administer taVNS at home twice daily for 4 weeks

4 weeks

Weekly electronic questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) at the end of treatment, electronic questionnaires

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous auricular vagus nerve stimulation

Trial Overview The study tests transcutaneous auricular vagus nerve stimulation (taVNS), a non-drug wearable intervention for managing anxiety in ASD patients at home. It involves self-administering taVNS twice daily for four weeks without affecting other mental health treatments.

How Is the Trial Designed?

Group I: tVNS Experimental Treatment 1 Intervention

All patients will receive at-home Transcutaneous auricular vagus nerve stimulation (taVNS) and assess the impact on multiple behavioral outcomes associated with ASD and anxiety. This is an open-label trial.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

In a pilot study involving 11 patients with treatment-resistant anxiety disorders, vagus nerve stimulation (VNS) was found to be relatively well tolerated and showed evidence of acute and long-term improvement in anxiety symptoms, particularly in patients with obsessive-compulsive disorder (OCD).

Out of the nine patients who completed the study, three showed significant improvement in anxiety ratings during the acute phase, and four years post-implantation, some patients continued to experience sustained improvements, suggesting VNS may be a promising adjunctive treatment for anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of vagus nerve stimulation (VNS) for treatment-resistant anxiety disorders. George, MS., Ward, HE., Ninan, PT., et al.[2022]

Transcutaneous Vagus Nerve Stimulation (tVNS) shows promise as a treatment for Autism Spectrum Disorder (ASD) by potentially regulating mood and social communication through vagal nerve stimulation.

tVNS may also help manage comorbid conditions associated with ASD, such as epilepsy and depression, by activating brain regions linked to these disorders, although the exact mechanism of action is still being studied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Vagus Nerve Stimulation: A Promising Method for Treatment of Autism Spectrum Disorders. Jin, Y., Kong, J.[2020]

Vagus nerve stimulation (VNS) therapy was found to be effective in improving quality of life (QOL) for patients with both autism spectrum disorder (ASD) and intractable epilepsy, with a notable improvement in mood observed at 12 months post-implantation.

Patients with ASD showed similar responses to VNS therapy as those without ASD, indicating that VNS can be a beneficial treatment option for this population, potentially leading to unique QOL improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vagus nerve stimulation therapy in patients with autism spectrum disorder and intractable epilepsy: results from the vagus nerve stimulation therapy patient outcome registry. Levy, ML., Levy, KM., Hoff, D., et al.[2022]

Vagus nerve stimulation (VNS) may serve as a promising additional treatment for anxiety disorders in children with autism spectrum disorder (ASD), especially when combined with exposure-based cognitive behavioral therapies, which currently have high relapse rates.

Preclinical research suggests that VNS can enhance the consolidation of extinction memories and reduce anxiety, indicating its potential effectiveness not only for anxiety but also for related conditions like depression and epilepsy in individuals with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vagus Nerve Stimulation as a Treatment for Fear and Anxiety in Individuals with Autism Spectrum Disorder. Shivaswamy, T., Souza, RR., Engineer, CT., et al.[2022]

Vagus nerve stimulation (VNS) may improve behavioral outcomes in individuals with autism spectrum disorders (ASD), based on a review of 11 studies, including case series and reports.

The potential benefits of VNS for behavior in ASD appear to occur independently of its effects on seizure control and mood, suggesting a unique mechanism of action that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation of autism spectrum disorders using vagal nerve stimulation. van Hoorn, A., Carpenter, T., Oak, K., et al.[2019]

The study demonstrated that remote supervised administration of transcutaneous auricular vagus nerve stimulation (taVNS) at home is feasible for 12 patients with autism spectrum disorder (ASD), achieving an 88.5% completion rate over 132 sessions.

Initial results indicated improvements in anxiety and sleep measures after 2 weeks of treatment, suggesting potential efficacy that warrants further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remotely supervised at-home delivery of taVNS for autism spectrum disorder: feasibility and initial efficacy. Black, B., Hunter, S., Cottrell, H., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive technique that stimulates the vagus nerve in the outer ear, potentially helping to treat pediatric neurodevelopmental and psychiatric disorders by addressing maladaptive neural plasticity.

Current literature suggests that taVNS may be a promising alternative treatment for conditions like autism spectrum disorder and ADHD, especially for children who do not respond to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic applications of transcutaneous auricular vagus nerve stimulation with potential for application in neurodevelopmental or other pediatric disorders. Zhu, S., Zhang, X., Zhou, M., et al.[2022]

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe, with a low incidence of mild and transient adverse effects, such as ear pain, headache, and tingling, reported in only 24.86% of the studies analyzed.

In a systematic review of 177 studies involving 6322 subjects, there was no significant difference in the risk of adverse events between taVNS and control groups, indicating that taVNS is a feasible option for clinical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Kim, AY., Marduy, A., de Melo, PS., et al.[2023]

A 10-year-old boy with both autism and epilepsy showed initial temporary improvement in seizure control after receiving vagus nerve stimulation, indicating its potential efficacy for seizure management.

In addition to seizure control, the boy experienced modest improvements in behavior and development, suggesting that vagus nerve stimulation may have positive behavioral side effects independent of its effects on seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autistic spectrum disorder, epilepsy, and vagus nerve stimulation. Hull, MM., Madhavan, D., Zaroff, CM.[2022]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a safe and effective neuromodulation therapy for a variety of conditions, including epilepsy, depression, and anxiety, indicating its broad therapeutic potential.

Despite its effectiveness, there is currently no standardization among taVNS devices, and further research is needed to clarify the relationship between stimulation parameters and therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. Wang, L., Wang, Y., Wang, Y., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10875019/

Effects of transcutaneous auricular vagus nerve stimulation ... Therefore, taVNS may be a promising alternative treatment for individuals with ASD, offering potential improvements in social cognition. Notably ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06258590

Study Details | NCT06258590 | taVNS for Anxiety in ASD This is a research study to find out if anxiety in patients with autism spectrum disorder are affected by a form of ear stimulation called transcutaneous ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10568329/

Remotely supervised at-home delivery of taVNS for autism ... Remotely supervised, proxy-administered, at-home delivery of taVNS is feasible in patients with ASD. Initial efficacy supports pursuing larger scale trials.

4. withpower.com withpower.com/trial/phase-autism-spectrum-disorder-11-2024-86321

Transauricular Vagus Nerve Stimulation for Autism ... Transcutaneous Vagus Nerve Stimulation (tVNS) shows promise as a treatment for Autism Spectrum Disorder (ASD) by potentially regulating mood and social ...

5. europepmc.org europepmc.org/article/med/28163670

Transcutaneous Vagus Nerve Stimulation: A Promising ... The results showed that VNS therapy improved the quality of life of patients with either Landau–Kleffner syndrome or autism comorbid epilepsy, and the ...

6. withpower.com withpower.com/trial/phase-anxiety-1-2024-c51b5

Vagus Nerve Stimulation for Anxiety in Autism Transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe, with a low incidence of mild and transient adverse effects, such as ear pain ...

7. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2016.00609/full

Transcutaneous Vagus Nerve Stimulation: A Promising ... The tVNS is a safe, non-invasive, and low-cost method modified from VNS (Kraus et al., 2007; Dietrich et al., 2008; Kreuzer et al., 2012). The rationale of tVNS ...