Objectively Diagnose and Monitor Treatment of Light Sensitivity

Randy Kardon

Status: Enrolling

Conditions: Traumatic Brain Injury; Photophobia; Migraine

Treatments: Device: Videography; Device: Electrophysiology; Device: Wrist-watch sensor device; Device: Ocular Coherence Tomography (OCT); Device: Pupillography

Study type: Interventional

Funder types: Other

Identifiers

NCT03694626

201604763

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 5 patient groups

Healthy Control subjects

Active Comparator group

Treatment:

Device: Ocular Coherence Tomography (OCT)

Device: Pupillography

Device: Electrophysiology

Device: Wrist-watch sensor device

Device: Videography

TBI Patients without photosensitivity

Active Comparator group

Treatment:

Device: Ocular Coherence Tomography (OCT)

Device: Pupillography

Device: Electrophysiology

Device: Wrist-watch sensor device

Device: Videography

Migraine patients without photosensitivity

Active Comparator group

Treatment:

Device: Ocular Coherence Tomography (OCT)

Device: Pupillography

Device: Electrophysiology

Device: Wrist-watch sensor device

Device: Videography

Migraine patients with photosensitivity

Active Comparator group

Treatment:

Device: Ocular Coherence Tomography (OCT)

Device: Pupillography

Device: Electrophysiology

Device: Wrist-watch sensor device

Device: Videography

TBI patients with photosensitivity

Active Comparator group

Treatment:

Device: Ocular Coherence Tomography (OCT)

Device: Pupillography

Device: Electrophysiology

Device: Wrist-watch sensor device

Device: Videography