Clinical trial NCT06233279: Study of Application of Transcutaneous Trigeminal Nerve Stimulation on Autism Spectrum Disorder
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: ASD
Lead sponsor: Nu Eyne Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Eligibility 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

Primary outcomes:
measure: Safety evaluation
timeFrame: baseline, 4 weeks
Secondary outcomes:
measure: Changes in Level of functioning
timeFrame: baseline, 4 weeks
measure: Changes in Social reciprocity
timeFrame: [Time Frame: baseline, 2 weeks, 4 weeks]
measure: Changes in Executive function
timeFrame: baseline, 2 weeks, 4 weeks
measure: Changes in Sleep disturbance
timeFrame: baseline, 2 weeks, 4 weeks
measure: Changes in Anxiety
timeFrame: baseline, 2 weeks, 4 weeks
measure: Changes in Sensory over - responsivity
timeFrame: baseline, 2 weeks, 4 weeks
measure: Changes in Clinical Global impression
timeFrame: baseline, 4 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hee Jeong Yoo, Ph. D., MD
role: PRINCIPAL_INVESTIGATOR
References: