NCT06233279

Study of Application of Transcutaneous Trigeminal Nerve Stimulation on Autism Spectrum Disorder

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: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Nu Eyne Co., Ltd. · Industry
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Not accepted

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 (-28\~0 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).

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DEVICE	Charge-Balanced, Symmetric Nerve Stimulation	Charge-Balanced, Symmetric Nerve Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days).
DEVICE	Sham Stimulation	Sham Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days).

Timeline

• Start date: 2022-11-15
• Primary completion: 2024-04-30
• Completion: 2024-08-30
• First posted: 2024-01-31
• Last updated: 2024-01-31

Locations

1 site across 1 country: South Korea