Use of Facial Feature to Objectively Diagnose and Monitor Treatment of Light Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Correlation of facial responses to light sensitivity
研究概览
简要总结
The purpose of this project is to provide a new framework for diagnosing and monitoring treatment of light sensitivity and headache by objective measurement of facial features, pupil responses, retinal electrical responses and autonomic nerve responses to light.
详细描述
Using objecting measurement of facial features, pupil responses, retinal electrical responses and autonomic nerve responses to light this project aims to provide a new framework for diagnosing and monitoring treatment of light sensitivity. The patient's responses will be measured with videography facial muscle electrical responses Electromyogram (EMG) measured from surface skin electrodes and retinal electrical responses (EMG) or electroretinogram (ERG) recorded from a portable hand-held device). Simultaneously, patient's will have their heart rate and skin conductance objectively monitored using wristwatch devices (E4, Empatica). If successful, this will open an immediate new way to objectively assess the mechanisms that lead to light sensitivity, and provide an approach to effectively treat, and manage the symptoms of light sensitivity and headache from different causes, including traumatic brain injury (TBI) and migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Control subjects:
- •Inclusion Criteria
- •Healthy individuals with normal eye exam in the previous year
- •Age 18-80
排除标准
- •History of eye or systemic disorder that affect the retina, optic nerve, visual pathway, or pupil defect: including glaucoma, optic neuropathy, or retinal disease, diabetes and/or hypertension that are not well controlled, history of head trauma, concussion, or TBI, history of cervical or spinal injury/surgery
- •Medications or eyedrops that would confound measuring the pupil light reflex and EMG: including topical autonomic drugs that could influence pupil size, ocular pharmacologic agents, sedative agents (e.g. benzodiazepines or barbiturates), opioid narcotics
- •Must not be light sensitive or get migraine headaches
- •TBI patients without photosensitivity or headache:
- •Inclusion Criteria
- •Age 18-80
- •Traumatic Brain Injury (TBI)
- •Exclusion Criteria
- •History of eye or systemic disorder that affect the retina, optic nerve, visual pathway, or pupil defect: including glaucoma, optic neuropathy, or retinal disease, diabetes and/or hypertension that are not well controlled
- •Medications or eyedrops that would confound measuring the pupil light reflex and EMG: including topical autonomic drugs that could influence pupil size, ocular pharmacologic agents, sedative agents (e.g. benzodiazepines or barbiturates), opioid narcotics - Must not be light sensitive or get migraine headaches (use headache criteria from Ana if we are including headaches)
- •Patients with photosensitivity from non-TBI causes Inclusion Criteria
- •Age 18-80
- •Photosensitivity: determined by patient reporting symptoms and there may or may not be an identified cause associated with their light sensitivity (i.e. history of uveitis, childhood exotropia, meningitis, radiation, tumor)
- •Exclusion Criteria
- •History of eye or systemic disorder that affect the retina, optic nerve, visual pathway, or pupil defect: including glaucoma, optic neuropathy, or retinal disease, diabetes and/or hypertension that are not well controlled, history of head trauma, concussion, or TBI, history of cervical or spinal injury/surgery
- •Medications or eyedrops that would confound measuring the pupil light reflex and EMG: including topical autonomic drugs that could influence pupil size, ocular pharmacologic agents, sedative agents (e.g. benzodiazepines or barbiturates), opioid narcotics
- •TBI patients with photosensitivity Inclusion Criteria
- •Age 18-80
- •Photosensitivity: determined by patient reporting symptoms and cause associated with their light sensitivity is post TBI
- •Exclusion Criteria
- •- History of eye or systemic disorder that affect the retina, optic nerve, visual pathway, or pupil defect: including glaucoma, optic neuropathy, or retinal disease, diabetes and/or hypertension that are not well controlled
研究组 & 干预措施
TBI Patients without photosensitivity
干预措施: Pupillography (Device)
TBI Patients without photosensitivity
干预措施: Ocular Coherence Tomography (OCT) (Device)
TBI Patients without photosensitivity
干预措施: Wrist-watch sensor device (Device)
TBI Patients without photosensitivity
干预措施: Videography (Device)
Migraine patients without photosensitivity
干预措施: Pupillography (Device)
Migraine patients without photosensitivity
干预措施: Videography (Device)
Migraine patients with photosensitivity
干预措施: Pupillography (Device)
Migraine patients with photosensitivity
干预措施: Ocular Coherence Tomography (OCT) (Device)
Migraine patients with photosensitivity
干预措施: Wrist-watch sensor device (Device)
TBI patients with photosensitivity
干预措施: Pupillography (Device)
TBI patients with photosensitivity
干预措施: Wrist-watch sensor device (Device)
TBI patients with photosensitivity
干预措施: Videography (Device)
TBI patients with photosensitivity
干预措施: Electrophysiology (Device)
Healthy Control subjects
干预措施: Pupillography (Device)
Healthy Control subjects
干预措施: Ocular Coherence Tomography (OCT) (Device)
Healthy Control subjects
干预措施: Wrist-watch sensor device (Device)
Healthy Control subjects
干预措施: Videography (Device)
Healthy Control subjects
干预措施: Electrophysiology (Device)
TBI Patients without photosensitivity
干预措施: Electrophysiology (Device)
Migraine patients without photosensitivity
干预措施: Ocular Coherence Tomography (OCT) (Device)
Migraine patients without photosensitivity
干预措施: Wrist-watch sensor device (Device)
Migraine patients without photosensitivity
干预措施: Electrophysiology (Device)
Migraine patients with photosensitivity
干预措施: Videography (Device)
Migraine patients with photosensitivity
干预措施: Electrophysiology (Device)
TBI patients with photosensitivity
干预措施: Ocular Coherence Tomography (OCT) (Device)
结局指标
主要结局
Correlation of facial responses to light sensitivity
时间窗: 1 Day
Hand held pupillography/videography, electroretinogram, and electrophysiology measurements are correlated to develop of an objective biological marker of light sensitivity.
Difference in objective biological markers of light sensitivity between light sensitive and normal subjects
时间窗: 1 Day
The correlation of facial responses to light sensitivity is compared between groups to test whether the measure can accurately distinguish light sensitivity.
次要结局
- Correlation of objective biological marker of light sensitivity to optic nerve structures(1 Day)
- Correlation of objective biological marker of light sensitivity to macula (structure found in the back of the eye).(1 Day)
研究者
Randy Kardon
Principal Investigator
University of Iowa