Autism Spectrum DisorderNCT06233279
Study of Application of Transcutaneous Trigeminal Nerve Stimulation on Autism Spectrum Disorder
A study testing Charge-Balanced, Symmetric Nerve Stimulation in people with Autism Spectrum Disorder, run by Nu Eyne Co., Ltd. at 1 site in South Korea.
Trial summary
This study aims to evaluate the safety and the efficacy of applying transcutaneous trigeminal nerve stimulator (NuEyne P01) on autism spectrum disorder. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Charge-Balanced, Symmetric Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Nov 2022to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, 13605
Hee Jeong Yoo, Ph. D., MD.
About this study
Official title: 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.
Read the 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).
- Conditions
- Autism Spectrum Disorder
- Being tested
- Charge-Balanced, Symmetric Nerve Stimulation, Sham Stimulation
- Keywords
- ASD
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Charge-Balanced, Symmetric Nerve StimulationDevice
Charge-Balanced, Symmetric Nerve Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days).
Sham StimulationDevice
Sham Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Charge-Balanced, Symmetric Nerve Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days). Receives: 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). Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 4 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: [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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start15 Nov 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nu Eyne Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hee Jeong Yoo, Ph. D., MD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233279
- Sponsor's protocol ID
- NE_PSY_001
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41617599
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06233279
- Acronym / sponsor ID
- NE_PSY_001
- Conditions
- Autism Spectrum Disorder
- Keywords
- ASD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nu Eyne Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the safety and the efficacy of applying transcutaneous trigeminal nerve stimulator (NuEyne P01) on autism spectrum disorder.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Charge-Balanced, Symmetric Nerve StimulationCharge-Balanced, Symmetric Nerve Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days). |
| Control Group | Sham comparator | Device: Sham StimulationSham Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days). |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Charge-Balanced, Symmetric Nerve StimulationCharge-Balanced, Symmetric Nerve Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days). | Device | Experimental Group |
| Sham StimulationSham Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days). | Device | Control Group |
Primary outcome
Safety evaluation
Time frame: baseline, 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.
7 secondary outcomes
Changes in Level of functioning
Time frame: baseline, 4 weeks
Changes in Social reciprocity
Time frame: [Time Frame: baseline, 2 weeks, 4 weeks]
Changes in Executive function
Time frame: baseline, 2 weeks, 4 weeks
Changes in Sleep disturbance
Time frame: baseline, 2 weeks, 4 weeks
Changes in Anxiety
Time frame: baseline, 2 weeks, 4 weeks
Changes in Sensory over - responsivity
Time frame: baseline, 2 weeks, 4 weeks
Changes in Clinical Global impression
Time frame: baseline, 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Derived from this study: PubMed 41617599Han 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee Jeong Yoo, Ph. D., MD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Charge-Balanced, Symmetric Nerve Stimulation in people with Autism Spectrum Disorder, run by Nu Eyne Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinho Jung, Ph.D candi. (+821083113509, jinho.jung@nueyne.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation (time frame: baseline, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06233279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.