Objectively Diagnose and Monitor Treatment of Light Sensitivity

Not Applicable

Recruiting

• Conditions: Photophobia; Traumatic Brain Injury; Migraine
• Interventions: Device: Pupillography; Device: Ocular Coherence Tomography (OCT); Device: Wrist-watch sensor device; Device: Videography; Device: Electrophysiology

• Registration Number: NCT03694626
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-10-01
• Study First Posted: 2018-10-03
• Study Start: 2019-07-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-17
• Primary Completion: 2028-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Control subjects	Ocular Coherence Tomography (OCT)	-
Healthy Control subjects	Electrophysiology	-
TBI Patients without photosensitivity	Ocular Coherence Tomography (OCT)	-
TBI Patients without photosensitivity	Wrist-watch sensor device	-
Migraine patients without photosensitivity	Ocular Coherence Tomography (OCT)	-
Migraine patients without photosensitivity	Wrist-watch sensor device	-
Migraine patients without photosensitivity	Electrophysiology	-
Healthy Control subjects	Wrist-watch sensor device	-
TBI Patients without photosensitivity	Pupillography	-
TBI Patients without photosensitivity	Videography	-
Healthy Control subjects	Pupillography	-
Migraine patients without photosensitivity	Pupillography	-
Migraine patients with photosensitivity	Pupillography	-
Healthy Control subjects	Videography	-
TBI Patients without photosensitivity	Electrophysiology	-
Migraine patients with photosensitivity	Wrist-watch sensor device	-
Migraine patients with photosensitivity	Videography	-
TBI patients with photosensitivity	Wrist-watch sensor device	-
Migraine patients without photosensitivity	Videography	-
Migraine patients with photosensitivity	Ocular Coherence Tomography (OCT)	-
TBI patients with photosensitivity	Ocular Coherence Tomography (OCT)	-
Migraine patients with photosensitivity	Electrophysiology	-
TBI patients with photosensitivity	Videography	-
TBI patients with photosensitivity	Electrophysiology	-
TBI patients with photosensitivity	Pupillography	-

Primary Outcome Measures

Name	Time	Method
Correlation of facial responses to light sensitivity	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	1 Day	The correlation of facial responses to light sensitivity is compared between groups to test whether the measure can accurately distinguish light sensitivity.

Secondary Outcome Measures

Name	Time	Method
Correlation of objective biological marker of light sensitivity to optic nerve structures	1 Day	Bio marker score will be correlated to optic nerve structure measurements made using Optical Coherence Tomography (OCT) to evaluate structural loss of the optic nerve.
Correlation of objective biological marker of light sensitivity to macula (structure found in the back of the eye).	1 Day	Bio marker score will be correlated to macula structure measurements made using Optical Coherence Tomography (OCT) to examine to evaluate structural loss of the macula (structure found in the back of the eye).

Trial Locations

Locations (1)

University of Iowa Health Care; 🇺🇸 Iowa City, Iowa, United States