Clinical trial NCT03694626: Objectively Diagnose and Monitor Treatment of Light Sensitivity
Official title: Use of Facial Feature to Objectively Diagnose and Monitor Treatment of Light Sensitivity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Photophobia
Traumatic Brain Injury
Migraine
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Healthy Control subjects:

Inclusion Criteria

* Healthy individuals with normal eye exam in the previous year
* Age 18-80

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
* 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
* 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

Primary outcomes:
measure: Correlation of facial responses to light sensitivity
timeFrame: 1 Day
measure: Difference in objective biological markers of light sensitivity between light sensitive and normal subjects
timeFrame: 1 Day
Secondary outcomes:
measure: Correlation of objective biological marker of light sensitivity to optic nerve structures
timeFrame: 1 Day
measure: Correlation of objective biological marker of light sensitivity to macula (structure found in the back of the eye).
timeFrame: 1 Day
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Health Care
state: Iowa
Study officials:
References: