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

Neuropix

Status: Not yet enrolling

Conditions: Autism Spectrum Disorder

Treatments: Device: vagus nerve stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT06473623

01A

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 7 to 26 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Treatment Arm

Experimental group

Description:

Receiving intervention of the non-invasive neurostimulation device.

Treatment:

Device: vagus nerve stimulation