Trial record 14 of 19 for:    Open Studies | "Dermatitis, Contact"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Ohio State University
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Andrew Hartwick, Ohio State University
ClinicalTrials.gov Identifier:
NCT01942564
First received: September 6, 2013
Last updated: September 13, 2013
Last verified: September 2013
  Purpose

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.


Condition
Head Injury
Traumatic Brain Injury (TBI)
Photosensitivity
Photophobia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Head Injury-associated Photosensitivity and Pupillary Function (HIPP) Study

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Pupil Responses [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Sleep Rhythms [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Daily rhythms of sleep and activity will be assessed in subjects with prior brain injury and compared to matched controls.

  • Light Exposure [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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.

  • Photosensitivity Symptoms [ Time Frame: Single visit - one day ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: August 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Case Subjects
  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
Control Subjects
  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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Cases: Age 18 or older with symptoms of increased photosensitivity since experiencing a head injury.

Controls: Matched to cases in age, sex and race.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01942564

Contacts
Contact: Andrew Hartwick, OD, PhD 614-688-8308 hartwick.4@osu.edu

Locations
United States, Ohio
College of Optometry Recruiting
Columbus, Ohio, United States, 43210
Contact: Andrew Hartwick, OD, PhD    614-688-8308    hartwick.4@osu.edu   
Principal Investigator: Andrew Hartwick, OD, PhD         
Sub-Investigator: Michael Earley, OD, PhD         
Sponsors and Collaborators
Ohio State University
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Andrew Hartwick, OD, PhD Ohio State University
  More Information

No publications provided

Responsible Party: Andrew Hartwick, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01942564     History of Changes
Other Study ID Numbers: 2013H0151, W81XWH-12-1-0434
Study First Received: September 6, 2013
Last Updated: September 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
traumatic brain injury
photophobia
photosensitivity
pupil

Additional relevant MeSH terms:
Dermatitis, Contact
Craniocerebral Trauma
Photosensitivity Disorders
Dermatitis, Phototoxic
Epilepsy, Reflex
Photophobia
Brain Injuries
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases
Skin Diseases
Dermatitis, Irritant
Dermatitis
Skin Diseases, Eczematous
Epilepsy
Brain Diseases
Central Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 11, 2014