NCT06293300招募中2 期
Understanding and Treating TBI Associated Photophobia With Botulinum Toxin Type A and Its Impact on Visual Function
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in visual photosensitivity thresholds (VPT) measured Ocular Photosensitivity Analyzer (OPA)
研究概览
简要总结
The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
BoNT-A Group
Experimental
Participants will receive BoNT-A intervention for up to 6 months.
干预措施: BoNT A (Drug)
结局指标
主要结局
Change in visual photosensitivity thresholds (VPT) measured Ocular Photosensitivity Analyzer (OPA)
时间窗: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
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.
Change in photophobia measured by Numerical Rating Scale
时间窗: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
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").
次要结局
- Change in severity of visual photosensitivity symptoms measured by Visual Light Sensitivity Questionnaire-8 (VLSQ-8)(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).(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)(Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.)
- Change in migraine symptom severity score measured by in Migraine Symptom Severity Score (MSSS)(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(Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.)
- Change in dry eye symptoms measured by the Dry Eye Questionnaire 5 (DEQ 5)(Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.)
- Change in ocular surface disease index measured by the Ocular Surface Disease Index (OSDI)(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)(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)(Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.)
研究者
Anat Galor
Professor
University of Miami
研究点 (2)
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