Applying nerve stimulation to treat 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
NA · Nu Eyne Co., Ltd. · NCT06233279
This study is testing if a new nerve stimulation device can help improve symptoms in children with autism spectrum disorder.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 7 Years to 12 Years |
| Sex | All |
| Sponsor | Nu Eyne Co., Ltd. (industry) |
| Locations | 1 site (Seongnam-si) |
| Trial ID | NCT06233279 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of transcutaneous trigeminal nerve stimulation using the NuEyne P01 device in children diagnosed with autism spectrum disorder. Participants will undergo a screening period followed by a 28-day intervention phase, during which they will visit the site multiple times and have tele-visits. The study includes both active nerve stimulation and sham stimulation to assess the treatment's effectiveness. The goal is to determine if this non-invasive approach can improve symptoms associated with autism.
Who should consider this trial
Good fit: Ideal candidates are children aged 7 to 12 years with a diagnosis of autism spectrum disorder and a total intelligence index of 70 or higher.
Not a fit: Patients with significant behavioral problems or those unable to understand the treatment due to limitations in intelligence or language skills may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new non-invasive option for managing symptoms of autism spectrum disorder in children.
How similar studies have performed: While the application of nerve stimulation for autism is a novel approach, similar studies in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seongnam-si
- Seoul National University Bundang Hospital — Seongnam-si, Korea, Republic of (RECRUITING)
Study contacts
- Principal investigator: Hee Jeong Yoo, Ph. D., MD — Seoul National University Bundang Hospital
- Study coordinator: Jinho Jung, Ph.D candi.
- Email: jinho.jung@nueyne.com
- Phone: +821083113509
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autism Spectrum Disorder, ASD