Treating light sensitivity after traumatic brain injury with Botox

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to investigate the effectiveness of Botulinum Toxin Type A (BoNT-A) in treating photophobia, or light sensitivity, in individuals who have experienced a traumatic brain injury (TBI). The study will enroll both civilians and veterans who report chronic photophobia and have a documented history of TBI. Participants must be at least 18 years old, able to consent, and have been on a stable medication regimen for the past three months. The trial will assess the impact of BoNT-A on visual function and overall quality of life for these patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Miami
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Anat Galor, MD/MSPH — University of Miami
• Study coordinator: Anat Galor, MD/MSPH
• Email: agalor@miami.edu
• Phone: (305) 3266000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.