Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS) for Treatment of Autism Spectrum Disorder

Not Applicable

Not yet recruiting

• Conditions: Autism Spectrum Disorder

• Registration Number: NCT06473623
• Lead Sponsor: Neuropix

Brief Summary

Non-invasive vagus nerve stimulation for the symptomatic improvements in Autism Spectrum Disorder

Detailed Description

A single arm open-label study in Autism Spectrum Disorder (ASD) for evaluating treatment effects of non-invasive VNS, specifically auricular fiber vagal nerve stimulation (afVNS). A total of 20 patients diagnosed with ASD will be recruited to evaluate the feasibility of home healthcare application of afVNS and for assessment of short-term treatment effects on symptoms and comorbidities. ASD patients will receive 1 x hour per day afVNS treatment over 14 days with a fixed neuromodulation protocol. The primary outcome measure is feasibility assessed from completion success and neurostimulation tolerance. Secondary outcome measures include changes in scores pre- and post- afVNS treatment for Clinician Global Clinical Impression (CGI-I), Clinician Global Impression Severity (CGI-S), Children's Anxiety Sensitivity Index (CASI-R), Parent-Rated Anxiety Scale for ASD (PRAS-ASD), Autistic Behavior Checklist (ABC), Cleveland Adolescent Sleep Questionnaire (CASQ), verbal fluency and biomarker measures in autonomic physiology.

Study Timeline

• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-19
• Study First Posted: 2024-06-25
• Status Verified: 2024-09
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Study Start: 2025-02
• Primary Completion: 2025-07
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Written informed consent
• Age: between 7 and 26 years
• Participants and parent/ guardian must read and write English
• Diagnosis of ASD as defined by ADOS-2 and DSM-5 criteria
• Full scale IQ of >80 from WASI
• Suffering from anxiety (total score of >49) on CASI-R at baseline

Exclusion Criteria

• Severe psychiatric disorders (e.g. bipolar, major depressive disorder)
• Severe neurological disorders (e.g. stroke, epilepsy)
• Bradyarrhythmia
• History of head trauma (surgery or tumor)
• Active medical implants (cochlear, VNS or pacemakers)
• Cerebral shunts
• Auricular skin disease that compromises placement of electrodes
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility for completed treatments and stimulation intensity tolerance	1 month	Completion success and neurostimulation tolerance

Secondary Outcome Measures

Name	Time	Method
Clinician Global Impression Severity (CGI-S)	1 month	For assessment of anxiety, gastrointestinal symptoms and social interactions and overall ASD
Autistic Behavior Checklist (ABC) scores	1 month	For measurements of 5 behavioral domains including irritability, social withdrawal, stereotypy, hyperactivity and inappropriate speech
Clinician Global Clinical Impression (CGI-I)	1 month	For core social impairment and overall level of cognitive, adaptive and social functioning
Parent-Rated Anxiety Scale for ASD (PRAS-ASD)	1 month	For anxiety assessment consisting of 25 questions related to anxiety ranging from 0 (none) to 3 (severe)