Ignite Creation Date:
2024-07-17 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473623
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-19
Brief Title:
Non-invasive Auricular Fiber Vagus Nerve Stimulation afVNS for Treatment of Autism Spectrum Disorder
Sponsor:
Neuropix
Organization:
Neuropix
Study Overview
Official Title:
Non-invasive Auricular Fiber Vagus Nerve Stimulation afVNS for Treatment of Autism Spectrum Disorder An Open-Label Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Childrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None