The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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).
University of Miami
Miami, Florida, United States
RECRUITINGChange in photophobia measured by Numerical Rating Scale
The change in numerical rating of average photophobia during the past week, ranging from 0 (for "no ocular pain") to 10 ("the most intense ocular pain imaginable").
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in visual photosensitivity thresholds (VPT) measured Ocular Photosensitivity Analyzer (OPA)
The change in the OPA visual photosensitivity thresholds, ranging from 0 to 4.51 log lux, with a lower VPT indicating less tolerance to light or increased light sensitivity.
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in severity of visual photosensitivity symptoms measured by Visual Light Sensitivity Questionnaire-8 (VLSQ-8)
Total score ranging from 8 to 40, with a higher score indicating more visual photosensitivity symptom severity.
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in severity of neuropathic ocular pain symptoms measured by Neuropathic Pain Symptom Inventory Questionnaire, modified for the Eye (NPSI-Eye).
Total score ranging from 0 to 100, with higher scores reflecting greater neuropathic ocular pain symptom severity.
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in visual function related to activities of daily living measured by Visual Function Questionnaire-25 (VFQ-25)
Total score ranging from 0 to 100, with higher scores indicating better quality of life.
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in migraine symptom severity score measured by in Migraine Symptom Severity Score (MSSS)
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Total score ranging from 0 to 21, with higher scores indicating greater migraine severity.
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in impact of headaches on daily life measured by Headache Impact Test (HIT)-6
Total score ranging from 36 to 78, with higher scores indicating greater impact of headaches have on a person's ability to function on the job, at school, at home and in social situations.
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in dry eye symptoms measured by the Dry Eye Questionnaire 5 (DEQ 5)
Total score ranging from 0 to 22, with higher scores indicating more dry eye symptoms.
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in ocular surface disease index measured by the Ocular Surface Disease Index (OSDI)
Total score ranging from 0 to 100, will be administered to assess dry eye symptoms, with higher scores indicating more dry eye symptoms and impact on daily activities.
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in pain intensity rating of aftersensations (AS) to repeated heat stimulation on the forehead measure by quantitative sensory testing (QST)
QST methodology will be used to measure the severity of painful sensations that remain present 15 seconds after presentation of 10 one-second presentations (each separated by one second) of a noxious stimulus to the skin of the forehead. Ratings of the "intensity of pain" on a 0 to 100 numerical rating scale (0 = "no pain"; 100 = "most intense pain imaginable") will be recorded for these aftersensations.
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Change in temporal summation (TS) of heat pain on the forehead measure by quantitative sensory testing (QST)
QST methodology will be used to measure the increase in pain intensity ratings that occur when repeated noxious stimuli are presented in rapid succession (i.e., temporal summation; TS). Ratings of the "intensity of pain" on a 0 to 100 numerical rating scale (0 = "no pain"; 100 = "most intense pain imaginable"). TS at each study time point will be determined by subtracting the rating of pain intensity at its peak during the rapid train of one-second noxious heat stimuli from the rating of pain intensity after a single one-second heat stimulus of the same temperature.
Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.