NCT04107610Unknown不适用
Development of a Pediatric Oculomotor and Vestibular Normative Database as an Essential Tool for Objective Evaluation of Concussion and Return-to-school/Play
Neurolign4 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2021年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- Normative data for I-PAS tests
研究概览
简要总结
The purpose of this study is to use a device called I-Portal® Portable Assessment System (I-PAS) to record eye movements in response to a number of visual and auditory stimuli designed to evaluate neural brain pathways related to oculomotor, vestibular, reaction time and cognitive (OVRT-C) development. The goal of this research is to collect normative data for the OVRT-C tests from a healthy pediatric population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females age 6 to 18 years of all races.
- •Parental/guardian permission (informed consent) and child assent
排除标准
- •History of head injury characterized by any of the following:
- •Resulting from penetrating trauma
- •Resulting from an automobile accident with significant associated injuries
- •Associated with a Glasgow Comma Scale Score of less than 13 at the time of injury
- •Associated with a loss of consciousness period greater than 30 minutes
- •Judged to be more than mild by medical staff
- •Requiring admission to the hospital for any reason
- •Associated with subdural or epidural hemorrhage
- •Persons with a previous history of mTBI in the past and who were symptomatic prior to current injury
- •Pregnancy, as documented by last menstrual period at study visits
- •Implants: Persons implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant, metal cervical spine hardware
- •Diagnosed with attention deficit hyperactivity disorder (ADHD), autism spectrum disorder, major depression, hypochondriasis, bipolar disorders, or schizophrenia.
- •Presence of severe aphasia or inability to follow commands and give independent responses
- •Documented neurodegenerative disorders (Multiple sclerosis, Parkinson's, Alzheimer's, Huntington)
- •Past history of seizures or convulsions
- •Prior disorders of hearing and balance including:
- •Meniere's disease
- •Multiple sclerosis
- •Vestibular neuritis
- •Vestibular schwannoma
- •Sudden sensorineural hearing loss
- •History of ear operation other than myringotomy and tube placement in the past
- •Acute or chronic disease of middle ear (infections, otitis)
- •History of cerebrovascular disorders including stroke, brainstem or cerebellar dysfunction within the last 3 months
- •Systemic disorders that include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, severe arthritis, diabetes, hypertension
- •Repeated history of syncope
- •Past or concomitant treatment with ototoxic chemotherapy
- •Previous contraindicating surgeries at the discretion of the study physician
- •Aminoglycosides in the past 6 months given via systemic or transtympanic administration
- •Concomitant treatment with any of the followings within the last 24 hours prior to testing if more than 2 doses have been taken:
- •Antihistamines: e.g. diphenhydramine, cyclizine, dimenhydrinate, meclizine, hydroxyzine, promethazine,
- •For ADHD and narcolepsy: e.g. Concerta, Daytrana, Methylin, Ritalin, Ritalin LA, Metadate ER, Aptensio XR, Cotempla XR-ODT, QuilliChew ER, and Quillivant XR
- •For schizophrenia and other mental diseases: e.g. Phenothiazines
- •Specific antibiotics: e.g. ethambutol, gentamycin
- •Anticonvulsant medications: e.g. topiramate
- •Currently suffering from dehydration
- •History or suspicion of substance abuse or addiction
- •Acute alcohol intoxication
- •Playing professional sports at the Olympic/league level
结局指标
主要结局
Normative data for I-PAS tests
时间窗: 3 years
Accuracy and gain across age: measurements of eye displacement versus stimulus displacement in saccadic and smooth pursuit tasks
次要结局
- Goggle evaluation(3 years)
研究者
研究点 (4)
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