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NCT03694626 | RECRUITING | Photophobia

Objectively Diagnose and Monitor Treatment of Light Sensitivity
Sponsor:

Randy Kardon

Information provided by (Responsible Party):

Randy Kardon

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.

Condition or disease

Photophobia

Traumatic Brain Injury

Migraine

Intervention/treatment

Pupillography

Ocular Coherence Tomography (OCT)

Wrist-watch sensor device

Videography

Electrophysiology

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : SCREENING
Official Title : Use of Facial Feature to Objectively Diagnose and Monitor Treatment of Light Sensitivity
Actual Study Start Date : 2019-07-11
Estimated Primary Completion Date : 2028-01-01
Estimated Study Completion Date : 2028-01-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
    • Objectively Diagnose and Monitor Treatment of Light Sensitivity

    Location Details

    NCT03694626

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    Locations

    RECRUITING

    United States, Iowa

    University of Iowa Health Care

    Iowa City, Iowa, United States, 52242