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Recruiting Phase 2 NCT06293300

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

Trial Parameters

Condition Traumatic Brain Injury
Sponsor University of Miami
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 50
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-09-30
Completion 2026-09-30
Interventions
BoNT A

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.

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

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