Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS) for Treatment of Autism Spectrum Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: vagus nerve stimulation.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder. Basic parameters: 7 years — 26 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS) for Treatment of Autism Spectrum Disorder: An Open-Label Trial
Overview
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.
Interventions
- Device vagus nerve stimulation
Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS)
Primary outcome measures
- Feasibility for completed treatments and stimulation intensity tolerance [Time frame: 2 weeks]
Secondary outcome measures (4)
- Clinician Global Clinical Impression (CGI-I) [Time frame: 2 weeks]
- Clinician Global Impression Severity (CGI-S) [Time frame: 2 weeks]
- Parent-Rated Anxiety Scale for ASD (PRAS-ASD) [Time frame: 2 weeks]
- Autistic Behavior Checklist (ABC) scores [Time frame: 2 weeks]
Eligibility criteria
Inclusion criteria
- Written informed consent
- Age: between 7 and 26 years
- Participants and parent/ guardian must have proficiency in English
- Diagnosis of ASD as defined by ADOS-2 or DSM-5 criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
Hong Kong · 1 center
- Hong Kong Science Park — Tai Po
Publications
- Jin Y, Kong J. Transcutaneous Vagus Nerve Stimulation: A Promising Method for Treatment of Autism Spectrum Disorders. Front Neurosci. 2017 Jan 20;10:609. doi: 10.3389/fnins.2016.00609. eCollection 2016. PMID 28163670
- Black B, Hunter S, Cottrell H, Dar R, Takahashi N, Ferguson BJ, Valter Y, Porges E, Datta A, Beversdorf DQ. Remotely supervised at-home delivery of taVNS for autism spectrum disorder: feasibility and initial efficacy. Front Psychiatry. 2023 Sep 28;14:1238328. doi: 10.3389/fpsyt.2023.1238328. eCollection 2023. PMID 37840787
- Molero-Chamizo A, Nitsche MA, Bolz A, Andujar Barroso RT, Alameda Bailen JR, Garcia Palomeque JC, Rivera-Urbina GN. Non-Invasive Transcutaneous Vagus Nerve Stimulation for the Treatment of Fibromyalgia Symptoms: A Study Protocol. Brain Sci. 2022 Jan 12;12(1):95. doi: 10.3390/brainsci12010095. PMID 35053839
Identifiers
NCT: NCT06473623 · 01A