Recruiting NCT06293300
Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BoNT A.
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Understanding and Treating TBI Associated Photophobia With Botulinum Toxin Type A and Its Impact on Visual Function
Overview
The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function.
Interventions
- 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).
Primary outcome measures
- Change in photophobia measured by Numerical Rating Scale [Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.]
- Change in visual photosensitivity thresholds (VPT) measured Ocular Photosensitivity Analyzer (OPA) [Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.]
Secondary outcome measures (9)
- Change in severity of visual photosensitivity symptoms measured by Visual Light Sensitivity Questionnaire-8 (VLSQ-8) [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). [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) [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) [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 [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) [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) [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) [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) [Time frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Miami — Miami
Identifiers
NCT: NCT06293300 · 20231056 · HT94252310608