An observational study in Head Injury, Traumatic Brain Injury (TBI) and Photosensitivity, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-25.
Sponsored by Ohio State University · Observational
After a head injury, many people find that exposure to light causes them increased discomfort. By measuring how the pupil in the eye constricts to flashes of red and blue light, this study will investigate whether this phenomenon is due to a change in the eye's sensitivity to light.
The pupils inside the eyes constrict in response to light stimulation. Different classes of cells within the human retina initiate this response. Recent research suggests that one of the ganglion cell types involved in this pupil response also plays a role in the photophobia experienced by migraine sufferers. The main aim of this study is to determine whether this type of ganglion cell becomes 'hypersensitive' after traumatic brain injury, thereby contributing to symptoms of increased photosensitivity experienced by many of these individuals.
In the first session of this study, subjects will be asked questions about their sensitivity to light and the reaction of their eyes' pupils to flashing red and blue lights will be measured. The subjects will be given a full eye examination to rule out other causes of increased photosensitivity.
In some cases, subjects will be asked to attend a second session roughly two weeks later. They will be asked to wear a watch that measures their daily activity/sleep rhythms and light exposure during this inter-session period. During the second session, further testing of the pupil responses to blue and red flickering light will be performed.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's enrollment of 40 is below the median of 117 across 557 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.
Compared within Brain Injuries, Traumatic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Craniocerebral Trauma. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Cases: Age 18 or older with symptoms of increased photosensitivity since experiencing a head injury.
Controls: Matched to cases in age, sex and race.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1. Age 18 years or older 2. Had a head injury that occurred at least 6 months prior to entering study 3. Have found lights more bothersome since injury
1. Age 18 years or older 2. Have not had a previous head injury 3. Have had a full eye examination at Ohio State University College of Optometry during last 6 months.
Pupil Responses
The pupil fluctuation evoked by blue and red flickering lights will be measured in patients with a prior brain injury and compared to matched controls.
Time frame: 2 weeks
Sleep Rhythms
Daily rhythms of sleep and activity will be assessed in subjects with prior brain injury and compared to matched controls.
Time frame: 2 weeks
Light Exposure
The exposure to red, blue and green components of the light spectrum will be quantified in patients with a prior brain injury, and compared to matched controls.
Time frame: 2 weeks
Photosensitivity Symptoms
Subjects will complete survey indicating symptoms they have experienced related to light sensitivity and will grade their discomfort after exposed to brief flashes of light.
Time frame: Single visit - one day
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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