Actively Recruiting
Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A)
Led by University of Miami · Updated on 2025-09-02
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function.
CONDITIONS
Official Title
Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects, civilians and veterans (expected 1:1 mix) of all races and ethnicities
- 18 years of age or older and able to consent
- Chronic photophobia with a score of 4 or higher on a 0-10 scale, lasting at least 6 months
- Remote history of TBI occurring more than 1 year ago, based on Department of Defense TBI criteria with documented ICD9/ICD10 codes
- Stable medication regimen for the past 3 months
- No prior Botulinum Toxin Type A treatment for orofacial conditions
- English is the primary language by self-report
You will not qualify if you...
- Presence of ocular diseases that could affect photophobia, including glaucoma, corneal or conjunctival scarring, corneal edema, uveitis, iris transillumination defects, or retinal degeneration
- Participation in another investigational drug study within 1 month prior to screening
- Pregnancy or potential pregnancy without a negative pregnancy test within 24 hours of MRI scans
- Contraindications to fMRI scanning, such as metal implants or pacemakers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
A
Anat Galor, MD/MSPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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