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Completed

NCT Number: NCT01942564

The Head Injury-associated Photosensitivity and Pupillary Function (HIPP) Study

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18+ years old
  • reports a previous head injury that occurred at least 6 months ago
  • score of 2 or 3 (mild TBI) on OSU-TBI ID Survey
  • best-corrected visual acuity of at least 20/30 in both eyes
  • reliable visual field

Exclusion criteria

  • pregnancy
  • significant afferent pupillary defect
  • previous history of neurodegenerative disease
  • intraocular pressure more than 21 mm Hg
  • significant visual field defect
  • active corneal pathology
  • history of retinal or optic nerve disease
  • strabismus (eye turn)

Treatment and study plan

Primary outcomes

  1. Pupil Responses

    Time frame: 2 weeks

    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.

Secondary outcomes

  1. Sleep Rhythms

    Time frame: 2 weeks

    Daily rhythms of sleep and activity will be assessed in subjects with prior brain injury and compared to matched controls.

  2. Light Exposure

    Time frame: 2 weeks

    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.

  3. Photosensitivity Symptoms

    Time frame: Single visit - one day

    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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • U.S. Army Medical Research and Development Command

Registry information

Acronym: HIPP

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Sep 16, 2013
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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