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| ID | Type | Description | Link |
|---|---|---|---|
| HT94252310608 | Other Grant/Funding Number | Department of Defense Awarding Office: U.S. Army Medical Research Acquisition Activity (USAMRAA) |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BoNT-A Group | Experimental | Participants will receive BoNT-A intervention for up to 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change 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"). | 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. | Baseline, 6-weeks post-intervention, and 12-weeks post-intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anat Galor, MD/MSPH | Contact | (305) 3266000 | agalor@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anat Galor, MD/MSPH | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
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Total score ranging from 0 to 100, with higher scores reflecting greater neuropathic ocular pain symptom severity. |
| 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. | Baseline, 6-weeks post-intervention, and 12-weeks post-intervention. |
| Change in migraine symptom severity score measured by in Migraine Symptom Severity Score (MSSS) | Total score ranging from 0 to 21, with higher scores indicating greater migraine severity. | 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. | 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. | 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. | 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. | 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. | Baseline, 6-weeks post-intervention, and 12-weeks post-intervention. |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |