RecruitingNot ApplicableNCT06258590

taVNS for Anxiety in ASD

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for the Treatment of Anxiety Comorbid With Autism Spectrum Disorder (ASD)


Sponsor

Medical University of South Carolina

Enrollment

10 participants

Start Date

Apr 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Investigators will recruit up to 10 patients with Anxiety comorbid with Autism Spectrum Disorder (ASD) from the outpatient clinics at MUSC. This pilot trial will be an open-label investigation of the safety and feasibility of transcutaneous auricular vagus nerve stimulation (taVNS) as a nonpharmacological wearable intervention used to manage anxiety and other neuropsychiatric symptoms at home, with patients/caretakers self-administering treatments. Each subject will undergo an initial in-person screening and be consented prior to participating in the study. This will be followed by an in-person training session with the subject (and caretaker if applicable), where they will learn how to self-administer taVNS and ask any pertinent questions. Participants will self-administer taVNS at home twice daily for 4 weeks. These treatments will not interfere with other aspects of their mental health care. Our investigators, over the prior 8 years, have demonstrated that taVNS is safe and feasible in the outpatient setting. Furthermore, investigators have recently demonstrated that taVNS is well tolerated and safely self-administered at home with remote monitoring. The investigators hypothesize that taVNS will be safe and feasible to administer at home in this new population. Results from this study may lead to further exploration of taVNS in this unique population.


Eligibility

Min Age: 12 YearsMax Age: 17 Years

Inclusion Criteria6

  • Ages 12-17
  • English speaking
  • Prior diagnosis of ASD using autism diagnostic observation schedule (ADOS)
  • Score \>24 on SCARED
  • IQ \>70
  • Have the capacity and ability to provide one's own assent, consent will be provided by legal guardian

Exclusion Criteria13

  • Facial or ear pain or recent ear trauma.
  • Metal implant devices in the head, heart or neck.
  • History of brain surgery.
  • History of myocardial infarction or arrhythmia, bradycardia.
  • Acute exacerbation of a chronic respiratory disorder or acute COVID-related symptoms.
  • Active GI symptoms with a history of diabetes mellitus or history of gastroparesis secondary to diabetes mellitus.
  • Personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium).
  • Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury.
  • Individuals suffering from frequent/severe headaches.
  • Individuals with a reported history of psychosis or mania, or individuals who are actively manic or psychotic.
  • Individuals who are catatonic or otherwise unable to participate in the informed consent process.
  • Moderate to severe alcohol or substance use disorder.
  • Pregnancy

Interventions

DEVICETranscutaneous auricular vagus nerve stimulation

Patients will receive non invasive vagus nerve stimulation via electrodes attached to the ear.


Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT06258590


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