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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06293300
Phase
PHASE2
Status
Recruiting
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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BoNT A — 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).

Study Details

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

Key Dates

Start date
Sep 30, 2024
Status verified
Aug 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BoNT-A Group
    Participants will receive BoNT-A intervention for up to 6 months.

Primary Outcome Measure

Change in photophobia measured by Numerical Rating Scale [ Time Frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Mariela Aguilar, PhD
[email protected]
3053266069
Anat Galor, MD/MSPH (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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