The Effect of Zinc Supplementation on the Efficacy and Duration of Botulinum Toxin for the Treatment of Oculofacial Spasm Disorders
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Jankovic Rating Scale
研究概览
简要总结
The purpose of this study is to determine whether zinc supplements are effective in enhancing the treatment of oculofacial spasm disorders with botulinum toxin.
详细描述
Botulinum Toxin (Botox) has been used for many years in the treatment of oculofacial dystonias such as blepharospasm and hemifacial spasm. It has also gained widespread use for cosmetic purposes. The efficacy and duration of its effect is not constant amongst all patients. Some patient respond very well, while others have no clinical benefit or the clinical benefit does not last as long as expected. Zinc is known to be an important co-factor in the molecular effects of Botox. The investigators hypothesize that one of the many factors that may contribute to the variability in the response to Botox may be the level of Zinc available within the neuromuscular junction of those patients. The investigators plan to to test whether or not giving patients supplemental Zinc with their Botox injections would help improve the magnitude and duration of the intended clinical effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •greater than the age 18 years old
- •patient with hemifacial spasm
- •patient with benign essential blepharospasm.
排除标准
- •patients who have received Botox within 3 months time,
- •patients prone to malabsorption (i.e. those with Celiac disease, inflammatory bowel disease, liver disease, laxative use)
- •patients who cannot tolerate zinc supplementation due to kidney disease, gastrointestinal disease, or any other medical condition.
研究组 & 干预措施
Placebo
干预措施: Sugar pill (Drug)
Zinc Group
干预措施: Zinc Supplement (Drug)
结局指标
主要结局
Jankovic Rating Scale
时间窗: 3 months post Botox injection
a well established scale used in the literature to grade the symptoms of patients with facial spasms disorders.
次要结局
- Treatment Duration Cycle(The time frame will vary with each patient. The time frame is in fact the outcome measure being measured. On average the Botox treatment cycles last 3 months, however this average may be affected by zinc supplements.)
- Blepharospasm Disability Index (BDI)(3 months post Botox injection)