Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06233279
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-11-08
Brief Title:
Study of Application of Transcutaneous Trigeminal Nerve Stimulation on Autism Spectrum Disorder
Sponsor:
Nu Eyne Co Ltd
Organization:
Nu Eyne Co Ltd
Study Overview
Official Title:
Single-center Double-blind Placebo-controlled Randomized Clinical Trials for Safety and Efficacy Assessment of Symptoms Related to Autism Spectrum Disorder Using NuEyne P01 in Patients With Autism Spectrum Disorder
Status:
RECRUITING
Status Verified Date:
2023-11
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:
This study aims to evaluate the safety and the efficacy of applying transcutaneous trigeminal nerve stimulator NuEyne P01 on autism spectrum disorder
Detailed Description:
Duration of study period per participant Screening period -280 days Intervention period 28 days Patient needs to visit site at least 4 times V1 V2 V4 V6 V2 can be done with V1 Tele-visit should be done on V3 day 7 V5 day 21
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