Treating light sensitivity after traumatic brain injury with Botox
Understanding and Treating TBI Associated Photophobia With Botulinum Toxin Type A and Its Impact on Visual Function
This study is testing if Botox can help people with light sensitivity after a traumatic brain injury feel better and improve their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06293300 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with chronic photophobia related to a history of traumatic brain injury.
Not a fit: Patients who do not have a history of traumatic brain injury or those who are not experiencing chronic photophobia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from light sensitivity following a traumatic brain injury.
How similar studies have performed: While there is limited data on the use of BoNT-A specifically for TBI-related photophobia, similar approaches have shown promise in treating other forms of chronic pain and sensitivity.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Miami, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.