Head InjuryHIPPNCT01942564
The Head Injury-associated Photosensitivity and Pupillary Function (HIPP) Study
An observational study of Head Injury and Traumatic Brain Injury (TBI), run by Ohio State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head Injury, Traumatic Brain Injury (TBI), Photosensitivity
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Keywords
- traumatic brain injury, photophobia, photosensitivity, pupil
- Medical subject headings
- Craniocerebral Trauma, Brain Injuries, Traumatic, Photosensitivity Disorders, Photophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (3)
Sleep Rhythms
Daily rhythms of sleep and activity will be assessed in subjects with prior brain injury and compared to matched controls.
Measured: 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.
Measured: 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.
Measured: Single visit - one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head InjuryStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Principal investigator, Andrew Hartwick, Ohio State University
- Investigators
- Andrew Hartwick, OD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942564
- Sponsor's protocol ID
- 2013H0151
- Other IDs
- W81XWH-12-1-0434
- Acronym
- HIPP
- Status last verified
- Sep 2017
- First submitted
- 6 Sep 2013
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Barker F, Cockerham G, Goodrich G, Hartwick A, Kardon R, Mick AB, Swanson M. Brain Injury Impact on the Eye and Vision. Optom Vis Sci. 2017 Jan;94(1):4-6. doi: 10.1097/OPX.0000000000001001. No abstract available.
PubMed 28009763Yuhas PT, Shorter PD, McDaniel CE, Earley MJ, Hartwick AT. Blue and Red Light-Evoked Pupil Responses in Photophobic Subjects with TBI. Optom Vis Sci. 2017 Jan;94(1):108-117. doi: 10.1097/OPX.0000000000000934.
PubMed 27464575
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Head Injury-associated Photosensitivity and Pupillary Function (HIPP) Study
- ClinicalTrials.gov ID
- NCT01942564
- Acronym / sponsor ID
- HIPP / 2013H0151
- Keywords
- traumatic brain injury, photophobia, photosensitivity, pupil
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- pregnancy
- significant afferent pupillary defect
- previous history of neurodegenerative disease
- intraocular pressure more than 21 mm Hg
- significant visual field defect
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Sleep Rhythms
Time frame: 2 weeks
Light Exposure
Time frame: 2 weeks
Photosensitivity Symptoms
Time frame: Single visit - one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Background: PubMed 28009763Barker F, Cockerham G, Goodrich G, Hartwick A, Kardon R, Mick AB, Swanson M. Brain Injury Impact on the Eye and Vision. Optom Vis Sci. 2017 Jan;94(1):4-6. doi: 10.1097/OPX.0000000000001001. No abstract available.
- Results publication: PubMed 27464575Yuhas PT, Shorter PD, McDaniel CE, Earley MJ, Hartwick AT. Blue and Red Light-Evoked Pupil Responses in Photophobic Subjects with TBI. Optom Vis Sci. 2017 Jan;94(1):108-117. doi: 10.1097/OPX.0000000000000934.
- Vision and Traumatic Brain Injury: The Outlook for Therapeutics - ARVO 2016 (Andrew Hartwick, speaker)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Hartwick, OD, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Injury and Traumatic Brain Injury (TBI), run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupil Responses (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01942564, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.