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

NCT ID: NCT06293300

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2026-09-30

Brief Summary

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

Traumatic Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BoNT-A Group

Participants will receive BoNT-A intervention for up to 6 months.

Group Type: EXPERIMENTAL

BoNT A

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Anat Galor

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anat Galor, MD/MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anat Galor, MD/MSPH

Role: CONTACT

agalor@miami.edu

(305) 3266000

Facility Contacts

Mariela Aguilar, PhD

Role: primary

maguilar1@miami.edu

3053266069

Other Identifiers

HT94252310608

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20231056

Identifier Type: -

Identifier Source: org_study_id