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

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

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Device: Charge-Balanced, Symmetric Nerve Stimulation; Device: Sham Stimulation

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).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jinho Jung, Ph.D candi.; Phone Number: +821083113509; Email: jinho.jung@nueyne.com
• Study Contact Backup: Name: PyeongHwa Eun, M.S.; Phone Number: +821095513095; Email: pyeonghwa.eun@nueyne.com

Study Locations

• Korea, Republic of
  • Seongnam-si, Korea, Republic of, 13605
    • Recruiting
    • Seoul National University Bundang Hospital
    • Contact: Hee Jeong Yoo, Ph. D., MD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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; Charge-Balanced, Symmetric Nerve Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days).
Sham Comparator: Control Group; Sham 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Level of functioning	This is measured by two questionnaires, WISC-IV and Vineland Adaptation Behavior Scale-II, to confirm cognitive function. It is can be judged by combining the results of each questionnaire test. This clinical trial, as an exploratory clinical trial, aims at seeing whether there is a statistical difference between before and after the treatment in observation items. If both items are significant, cognitive function is considered significant.	baseline, 4 weeks
Changes in Social reciprocity	This is measured in five questionnaires, Aberrant Behavior Checklist-II (ABC-2), Autistic Quotient (AQ), Social Responsiveness Scale-2 (SRS-2), Korean Childhood autism rating scale (K-CARS-2), Social communication questionnaire (SCQ) to confirm sociality. It can be judged by combining the results of each questionnaire test. This clinical trial, as an exploratory clinical trial, aims at seeing whether there is a statistical difference between before and after the treatment in observation items. This clinical trial, as an exploratory clinical trial, aims at seeing whether there is a statistical difference between before and after the treatment in observation items. If more than three are significant, the Social reciprocity is considered significant. This result is judged to be significant as the result value is lower.	[Time Frame: baseline, 2 weeks, 4 weeks]
Changes in Executive function	This is measured in five questionnaires, Children's color trail making test 1 & 2 (CCTT-1 & 2), Stroop test(color&word), Advanced test of attention, Wisconsin card sorting test, Korean - ADHD Rating Scale, to confirm Executive function. It can be judged by combining the results of each questionnaire test. This clinical trial, as an exploratory clinical trial, aims at seeing whether there is a statistical difference between before and after the treatment in observation items. If more than three are significant, the Executive function is considered significant.	baseline, 2 weeks, 4 weeks
Changes in Sleep disturbance	Sleep disturbance is confirmed through the Korean version of the Children's Sleep Habits Questionnaire (K-CSHQ). This clinical trial, as an exploratory clinical trial, aims at seeing whether there is a statistical difference between before and after the treatment in observation items. This result is judged to be significant as the result value is lower.	baseline, 2 weeks, 4 weeks
Changes in Anxiety	This is measured in two questionnaires, Korean Child Behavior Checklist (K-CBCL), The Korean version of State and Trait Anxiety Inventory for Children (K-STAIC), to confirm Anxiety. It can be judged by combining the results of each questionnaire test. The higher the score, the higher the Anxiety. This clinical trial, as an exploratory clinical trial, aims at seeing whether there is a statistical difference between before and after the treatment in observation items. If both items are significant, cognitive function is considered significant.	baseline, 2 weeks, 4 weeks
Changes in Sensory over - responsivity	This is measured by Short Sensory Profile -2 (SSP-2) to confirm sensory over-responsivity. The higher the score, the higher the sensory over-responsivity. This clinical trial, as an exploratory clinical trial, aims at seeing whether there is a statistical difference between before and after the treatment in observation items. This result is judged to be significant as the result value is lower.	baseline, 2 weeks, 4 weeks
Changes in Clinical Global impression	This is determined through patient interviews. This clinical trial, as an exploratory clinical trial, aims at seeing whether there is a statistical difference between before and after the treatment in observation items. This result is judged to be significant as the result value is lower.	baseline, 4 weeks

Collaborators and Investigators

• Sponsor: Nu Eyne Co., Ltd.
• Investigators: Principal Investigator: Hee Jeong Yoo, Ph. D., MD, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Estimated): January 31, 2024

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: ASD
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: NE_PSY_001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No