NCT06233279招募中不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety evaluation
研究概览
简要总结
This study aims to evaluate the safety and the efficacy of applying transcutaneous trigeminal nerve stimulator (NuEyne P01) on autism spectrum disorder.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental Group
Experimental
Charge-Balanced, Symmetric Nerve Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days).
干预措施: Charge-Balanced, Symmetric Nerve Stimulation (Device)
Control Group
Sham Comparator
Sham Stimulation device is used during night sleep for eight hours each day for 4 weeks (28 days).
干预措施: Sham Stimulation (Device)
结局指标
主要结局
Safety evaluation
时间窗: 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.
次要结局
- Changes in Level of functioning(baseline, 4 weeks)
- Changes in Clinical Global impression(baseline, 4 weeks)
- Changes in Sleep disturbance(baseline, 2 weeks, 4 weeks)
- Changes in Social reciprocity([Time Frame: baseline, 2 weeks, 4 weeks])
- Changes in Anxiety(baseline, 2 weeks, 4 weeks)
- Changes in Executive function(baseline, 2 weeks, 4 weeks)
- Changes in Sensory over - responsivity(baseline, 2 weeks, 4 weeks)
研究者
研究点 (1)
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