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This study aims to evaluate the safety and the efficacy of applying transcutaneous trigeminal nerve stimulator (NuEyne P01) on autism spectrum disorder.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Charge-Balanced, Symmetric Nerve Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days). |
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| Control Group | Sham Comparator | Sham Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinho Jung, Ph.D candi. | Contact | +821083113509 | jinho.jung@nueyne.com | |
| PyeongHwa Eun, M.S. | Contact | +821095513095 | pyeonghwa.eun@nueyne.com |
| Name | Affiliation | Role |
|---|---|---|
| Hee Jeong Yoo, Ph. D., MD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | 13605 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41617599 | Derived | 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;23(1):e00838. doi: 10.1016/j.neurot.2026.e00838. Epub 2026 Jan 29. |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Sham Stimulation | Device | Sham Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days). |
|
| 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 |