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Diagnosing and Monitoring Light Sensitivity in TBI and Migraine

This study aims to find new ways to diagnose and track light sensitivity, especially in people with photophobia (light sensitivity), traumatic brain injury (TBI), and migraine. Researchers will use several devices to measure your body's responses to light. These include a hand-held device called a pupillometer/electroretinogram (RETeval) to check pupil and retinal responses, a special camera (Ocular Coherence Tomography or OCT) to look at your optic nerve and retina, and wrist-watch sensors (E4, Empatica) to monitor heart rate and skin changes. They will also use video cameras and electrodes (Electromyogram or EMG) to record facial and eyelid movements. The goal is to see how these measurements correlate with your light sensitivity and to find objective markers that can help diagnose and monitor treatment. You may be able to join if you are between 18 and 80 years old and are generally healthy. The study's status is currently unclear.

Study design
This is an interventional study with a planned enrollment of 120 participants. It aims to compare objective biological markers of light sensitivity between light-sensitive and normal individuals.
What's involved
You will undergo various measurements using devices like a pupillometer, OCT camera, wrist-watch sensors, video cameras, and electrodes. These tests will involve brief light stimuli and recordings of your body's responses.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, including the correlation of facial responses to light sensitivity and differences in objective biological markers, will be measured at 1 Day.

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NCT03694626

Objectively Diagnose and Monitor Treatment of Light Sensitivity

Recruiting
NAAges 18–80InterventionalScreening
Randy Kardon
~120 participants
Updated 2025-11-24 on ClinicalTrials.gov
What's tested:PupillographyOcular Coherence Tomography (OCT)Wrist-watch sensor deviceVideographyElectrophysiology

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Correlation of facial responses to light sensitivity
Measured over 1 Day
+1 more outcome measured

Conditions

Photophobia
Traumatic Brain Injury
Migraine

Explore related trials

MigrainePhotophobiaTraumatic Encephalopathy

Where it's being run

1 sites across 1 states
Iowa1

Who to contact

Julie Nellis, BSN
[email protected]
319-356-2780
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Healthy individuals with normal eye exam in the previous year
Age 18-80
Age 18-80
Traumatic Brain Injury (TBI)
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)
Age 18-80
Photosensitivity: determined by patient reporting symptoms and cause associated with their light sensitivity is post TBI
TBI

Exclusion

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
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)
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

What this trial measures

  • Correlation of facial responses to light sensitivity1 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 subjects1 Day

    The correlation of facial responses to light sensitivity is compared between groups to test whether the measure can accurately distinguish light sensitivity.