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

NCT06233279 | Unknown

• 1 other identifier: NE_PSY_001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Autism Spectrum Disorder

Keywords

ASD

Outcome Measures

Primary Outcomes (1)

• Safety evaluation

  Occurrence of adverse events caused by the investigational device, including psychiatric abnormality, skin abnormality at the contact site, headache, sleepiness, trigeminal nerve abnormality, etc. is checked.

  baseline, 4 weeks

Secondary Outcomes (7)

• Changes in Level of functioning

  baseline, 4 weeks

• Changes in Social reciprocity

  [Time Frame: baseline, 2 weeks, 4 weeks]

• Changes in Executive function

  baseline, 2 weeks, 4 weeks

• Changes in Sleep disturbance

  baseline, 2 weeks, 4 weeks

• Changes in Anxiety

  baseline, 2 weeks, 4 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Device: Charge-Balanced, Symmetric Nerve Stimulation

Control Group

SHAM COMPARATOR

Sham Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days).

Device: Sham Stimulation

Interventions

Charge-Balanced, Symmetric Nerve Stimulation DEVICE

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

Experimental Group

Sham Stimulation DEVICE

Sham Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days).

Control Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children over 7 years old and under 12 years old
• Patients diagnosed with autism spectrum disorder
• A person who has a total intelligence index of 70 or higher and has no problems with basic language communication
• A person who agrees not to use any medical device other than this clinical trial medical device during the clinical trial period
• A person who does not take a concurrent drug from screening to the end of the study, or who can maintain the concurrent drug during the clinical trial period without any change or addition
• Voluntary written consent to participate in this clinical trial

You may not qualify if:

• Those who participated in other clinical trials within 30 days from the screening date
• If it is difficult to understand the contents of treatment due to the limitation of intelligence index or language ability, and if it is difficult to conduct a study
• When there is a risk of clinically significant behavioral problems, emotional control problems, psychiatric symptoms, self-harm, or other harm that can affect the treatment process
• Psychiatric hospitalization history
• A person with acute or chronic medical or mental illness
• A person with a history of seizures
• Serious trauma and surgery within 1 month
• A person who is deemed to have a problem with the adhesion of electrodes due to inflammatory reactions or other dermatological problems on the skin around the forehead to which electrodes of clinical trial medical devices are attached
• If it is need to take sleep medications \[benzodiazepine, melatonin, trazodone\] (\*However, it is participated after having a washout period of at least two weeks.)
• A person who is deemed to have other reasons for prohibition of use of clinical trial medical devices (including heart-related problems, seizures, metal or electronic devices implanted in the head, people with unknown pain, pacemaker transplant, etc.)
• When it is determined by the researcher that it is difficult for the subject to continue voluntary participation in the study due to the lack of cooperation and motivation for treatment
• Other cases where it is deemed difficult to participate in the study by the researcher's judgment

Sponsors & Collaborators

• Nu Eyne Co., Ltd.: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, 13605, South Korea

RECRUITING

Related Publications (1)

• Han JH, Kim YR, Lee Y, Park Y, Kim D, Bong G, Yoo HJ. Double-blind, sham-controlled, pilot study of trigeminal nerve stimulation for autism spectrum disorder. Neurotherapeutics. 2026 Jan 29:e00838. doi: 10.1016/j.neurot.2026.e00838. Online ahead of print.

  PMID: 41617599 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Hee Jeong Yoo, Ph. D., MD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinho Jung, Ph.D candi.

CONTACT

+821083113509; jinho.jung@nueyne.com

PyeongHwa Eun, M.S.

CONTACT

+821095513095; pyeonghwa.eun@nueyne.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: January 31, 2024
• Study Start: November 15, 2022
• Primary Completion: April 30, 2024
• Study Completion: August 30, 2024
• Last Updated: January 31, 2024

Record last verified: 2023-11

Locations

KR (1)