RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-09-30

Study Completion:2026-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06293300

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Study Contact

Anat Galor, MD/MSPH

CONTACT

(305) 3266000

agalor@miami.edu

Principal Investigator

Anat Galor, MD/MSPH

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

Anat Galor, MD/MSPH, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2024-09-30

Study Completion Date2026-08-30

Study Record Updates

Study Start Date2024-09-30

Study Completion Date2026-08-30

Terms related to this study

Additional Relevant MeSH Terms

Traumatic Brain Injury