Clinical trial NCT06293300: Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A)
Official title: Understanding and Treating TBI Associated Photophobia With Botulinum Toxin Type A and Its Impact on Visual Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Traumatic Brain Injury
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-03-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Change in photophobia measured by Numerical Rating Scale
timeFrame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
measure: Change in visual photosensitivity thresholds (VPT) measured Ocular Photosensitivity Analyzer (OPA)
timeFrame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Secondary outcomes:
measure: Change in severity of visual photosensitivity symptoms measured by Visual Light Sensitivity Questionnaire-8 (VLSQ-8)
timeFrame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
measure: Change in severity of neuropathic ocular pain symptoms measured by Neuropathic Pain Symptom Inventory Questionnaire, modified for the Eye (NPSI-Eye).
timeFrame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
measure: Change in visual function related to activities of daily living measured by Visual Function Questionnaire-25 (VFQ-25)
timeFrame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
measure: Change in migraine symptom severity score measured by in Migraine Symptom Severity Score (MSSS)
timeFrame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
measure: Change in impact of headaches on daily life measured by Headache Impact Test (HIT)-6
timeFrame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
measure: Change in dry eye symptoms measured by the Dry Eye Questionnaire 5 (DEQ 5)
timeFrame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
measure: Change in ocular surface disease index measured by the Ocular Surface Disease Index (OSDI)
timeFrame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
measure: Change in pain intensity rating of aftersensations (AS) to repeated heat stimulation on the forehead measure by quantitative sensory testing (QST)
timeFrame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
measure: Change in temporal summation (TS) of heat pain on the forehead measure by quantitative sensory testing (QST)
timeFrame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Anat Galor, MD/MSPH
role: PRINCIPAL_INVESTIGATOR
References: