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Trial · NCT06233279

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

NCT06233279, Not applicable, Unknown, Nu Eyne Co., Ltd.

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study of Application of Transcutaneous Trigeminal Nerve Stimulation on Autism Spectrum Disorder. Trials, record NCT06233279. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06233279

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Study of Application of Transcutaneous Trigeminal Nerve Stimulation on Autism Spectrum Disorder
NCT number
NCT06233279
Status
Unknown
Phases
Not applicable
Enrollment
30 participants, estimated
Lead sponsor
Nu Eyne Co., Ltd.
Conditions
Autism Spectrum Disorder
Interventions
Charge-Balanced, Symmetric Nerve Stimulation, Sham Stimulation
First posted
2024-01-31
Last updated
2024-01-31

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimarySafety evaluationbaseline, 4 weeks
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.
SecondaryChanges in Level of functioningbaseline, 4 weeks
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.
SecondaryChanges in Social reciprocity[Time Frame: baseline, 2 weeks, 4 weeks]
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.
SecondaryChanges in Executive functionbaseline, 2 weeks, 4 weeks
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.
SecondaryChanges in Sleep disturbancebaseline, 2 weeks, 4 weeks
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.
SecondaryChanges in Anxietybaseline, 2 weeks, 4 weeks
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.
SecondaryChanges in Sensory over - responsivitybaseline, 2 weeks, 4 weeks
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.
SecondaryChanges in Clinical Global impressionbaseline, 4 weeks
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.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
41617599DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests4

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed asSource
Card Sorting Test (Berg)Secondary outcomeConductCognition
Stroop Color-Word TestSecondary outcomeConductCognition
Trail Making Test ASecondary outcomeConductCognition
Trail Making Test BSecondary outcomeConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06233279

GET https://conductscience.org/api/trials/v1/NCT06233279/registered