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

Traumatic Brain Injury Clinical Trial

Official title:

Understanding and Treating TBI Associated Photophobia With Botulinum Toxin Type A and Its Impact on Visual Function

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06293300
• Other study ID #: 20231056
• Secondary ID: HT94252310608
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 1, 2024
• Est. completion date: August 30, 2026

Study information

• Verified date: April 2024
• Source: University of Miami
• Contact: Anat Galor, MD/MSPH
• Phone: (305) 3266000
• Email: agalor[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 30, 2026
• Est. primary completion date: August 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Photophobia
• Traumatic Brain Injury

Intervention

Drug:
• BoNT A
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).

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Secondary	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.
Secondary	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.	Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.