Autism Spectrum Disorder
Conditions
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.
Interventions
DEVICEvagus nerve stimulation
Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS)
Sponsors
Neuropix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 26 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility for completed treatments and stimulation intensity tolerance | 2 weeks | Completion success and neurostimulation tolerance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Global Clinical Impression (CGI-I) | 2 weeks | For core social impairment and overall level of cognitive, adaptive and social functioning |
| Clinician Global Impression Severity (CGI-S) | 2 weeks | For assessment of anxiety, gastrointestinal symptoms and social interactions and overall ASD |
| Parent-Rated Anxiety Scale for ASD (PRAS-ASD) | 2 weeks | For anxiety assessment consisting of 25 questions related to anxiety ranging from 0 (none) to 3 (severe) |
| Autistic Behavior Checklist (ABC) scores | 2 weeks | For measurements of 5 behavioral domains including irritability, social withdrawal, stereotypy, hyperactivity and inappropriate speech |
Countries
Hong Kong
Contacts
Primary ContactDaniel Ko, PhD
Backup ContactAngela Peng, Bsc
Outcome results
None listed