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

NCT06233279 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-01-31

No results posted yet for this study

Summary

This study aims to evaluate the safety and the efficacy of applying transcutaneous trigeminal nerve stimulator (NuEyne P01) on autism spectrum disorder.

Conditions

Interventions

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).

Sponsors & Collaborators

  • Nu Eyne Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hee Jeong Yoo, Ph. D., MD · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2024-04-30
Completion
2024-08-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06233279 on ClinicalTrials.gov