Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A)

April 23, 2024 updated by: Anat Galor, University of Miami

Understanding and Treating TBI Associated Photophobia With Botulinum Toxin Type A and Its Impact on Visual Function

The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
        • Contact:
        • Principal Investigator:
          • Anat Galor, MD/MSPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Recruit and enroll male and female subjects, civilians and veterans (1:1 mix anticipated, i.e., n = 25 from each group) of all races and ethnicities.
  • ≥18 years of age who are able to consent.
  • Report chronic photophobia (Numerical Rating Scale ≥4 on a 0-10 scale, photophobia present ≥6 months) with a remote history of TBI (>1 year).
  • Inclusion into the study with regard to TBI status will be based on the Department of Defense Standard Surveillance Case Definition for TBI Adapted for Armed Forces Health Surveillance Division (AFHSB) Use. This can include one hospitalization or outpatient medical encounter with documented International Classification of Diseases (ICD9/ICD10) codes as identified within the Surveillance Case Definition.
  • Subjects must also have been on a stable medication regimen for the past 3 months and must be naïve to BoNT-A treatment for orofacial conditions.
  • English as primary language (by self-report).

Exclusion Criteria:

  • Individuals with ocular diseases that may confound photophobia, such as glaucoma, corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, retinal degeneration, etc.
  • Patients who are participating in another study with an investigational drug within one month prior to screening.
  • Pregnant individuals. Pregnant subjects will not be scanned in the functional Magnetic Resonance Imaging (fMRI). Although there are no known risks associated with MRI during pregnancy, according to facility policy, University of Miami will not scan someone that is pregnant. Therefore, all women of childbearing potential (menstruating or >12 years old) must complete a for stating that are not pregnant within 24 hours of each MRI scan.
  • Individuals with contraindications to fMRI scanning (e.g. metal implants, pacemaker) will not be offered inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BoNT-A Group
Participants will receive BoNT-A intervention for up to 6 months.
Drug: BoNT A
Participants with TBI-associated photophobia will come one time in person to the clinic and receive 35 Units of BoNT-A injected in 7 forehead sites (0.1 cc in each location).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in photophobia measured by Numerical Rating Scale
Time Frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
The change in numerical rating of average photophobia during the past week, ranging from 0 (for "no ocular pain") to 10 ("the most intense ocular pain imaginable").
Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in visual photosensitivity thresholds (VPT) measured Ocular Photosensitivity Analyzer (OPA)
Time Frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
The change in the OPA visual photosensitivity thresholds, ranging from 0 to 4.51 log lux, with a lower VPT indicating less tolerance to light or increased light sensitivity.
Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in severity of visual photosensitivity symptoms measured by Visual Light Sensitivity Questionnaire-8 (VLSQ-8)
Time Frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Total score ranging from 8 to 40, with a higher score indicating more visual photosensitivity symptom severity.
Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in severity of neuropathic ocular pain symptoms measured by Neuropathic Pain Symptom Inventory Questionnaire, modified for the Eye (NPSI-Eye).
Time Frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Total score ranging from 0 to 100, with higher scores reflecting greater neuropathic ocular pain symptom severity.
Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in visual function related to activities of daily living measured by Visual Function Questionnaire-25 (VFQ-25)
Time Frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Total score ranging from 0 to 100, with higher scores indicating better quality of life.
Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in migraine symptom severity score measured by in Migraine Symptom Severity Score (MSSS)
Time Frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Total score ranging from 0 to 21, with higher scores indicating greater migraine severity.
Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in impact of headaches on daily life measured by Headache Impact Test (HIT)-6
Time Frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Total score ranging from 36 to 78, with higher scores indicating greater impact of headaches have on a person's ability to function on the job, at school, at home and in social situations.
Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in dry eye symptoms measured by the Dry Eye Questionnaire 5 (DEQ 5)
Time Frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Total score ranging from 0 to 22, with higher scores indicating more dry eye symptoms.
Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in ocular surface disease index measured by the Ocular Surface Disease Index (OSDI)
Time Frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Total score ranging from 0 to 100, will be administered to assess dry eye symptoms, with higher scores indicating more dry eye symptoms and impact on daily activities.
Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in pain intensity rating of aftersensations (AS) to repeated heat stimulation on the forehead measure by quantitative sensory testing (QST)
Time Frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
QST methodology will be used to measure the severity of painful sensations that remain present 15 seconds after presentation of 10 one-second presentations (each separated by one second) of a noxious stimulus to the skin of the forehead. Ratings of the "intensity of pain" on a 0 to 100 numerical rating scale (0 = "no pain"; 100 = "most intense pain imaginable") will be recorded for these aftersensations.
Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in temporal summation (TS) of heat pain on the forehead measure by quantitative sensory testing (QST)
Time Frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
QST methodology will be used to measure the increase in pain intensity ratings that occur when repeated noxious stimuli are presented in rapid succession (i.e., temporal summation; TS). Ratings of the "intensity of pain" on a 0 to 100 numerical rating scale (0 = "no pain"; 100 = "most intense pain imaginable"). TS at each study time point will be determined by subtracting the rating of pain intensity at its peak during the rapid train of one-second noxious heat stimuli from the rating of pain intensity after a single one-second heat stimulus of the same temperature.
Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Anat Galor, MD/MSPH, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20231056
  • HT94252310608 (Other Grant/Funding Number: Department of Defense Awarding Office: U.S. Army Medical Research Acquisition Activity (USAMRAA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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