Clinical trial NCT06473623: Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS) for Treatment of Autism Spectrum Disorder
Official title: Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS) for Treatment of Autism Spectrum Disorder: an Open-Label Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Neuropix
Sponsor class: INDUSTRY
First posted: 2024-06-25
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility for completed treatments and stimulation intensity tolerance
timeFrame: 1 month
Secondary outcomes:
measure: Clinician Global Clinical Impression (CGI-I)
timeFrame: 1 month
measure: Clinician Global Impression Severity (CGI-S)
timeFrame: 1 month
measure: Parent-Rated Anxiety Scale for ASD (PRAS-ASD)
timeFrame: 1 month
measure: Autistic Behavior Checklist (ABC) scores
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Neuropix
name: Daniel Ko, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.