Exploratory Study on the Timing of MS Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- number of days with appearance or worsening of symptoms
研究概览
简要总结
The investigators' overall hypothesis is that appearance or worsening of relapsing-remitting multiple sclerosis (RR-MS) symptoms are affected by various factors including stress, hormonal cycles, illness and missed medications.
详细描述
Fluctuations in MS symptoms in women with RR-MS might be affected by a variety of factors. To determine which factors are important, we are asking subjects to fill out a diary and calendar on a daily basis for 90 days. After an initial instructional meeting over the phone, the materials are filled out at home and returned monthly via postage-paid envelopes provided by the study. Compensation ($10 gift card) is sent after each monthly diary is received. The diary includes a list of symptoms and a rank scale for the women to show subtle changes in MS symptoms. The calendar allows the subject to denote additional factors such as stress, hormonal cycles, illnesses or immunizations and changed or missed medications. We anticipate that statistical analysis will reveal which of these factors affect women with relapsing-remitting multiple sclerosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosed with relapsing-remitting multiple sclerosis
排除标准
- •no diagnosis of relapsing-remitting MS
- •diagnosis of any other autoimmune disease or fibromyalgia
- •peri-, post-, or surgically menopausal
- •pregnant within past year or nursing
- •history of chemotherapy
- •on experimental medications
- •treatment with steroids in the last 30 days
研究组 & 干预措施
Relapsing-remitting multiple sclerosis
Females with relapsing-remitting multiple sclerosis
结局指标
主要结局
number of days with appearance or worsening of symptoms
时间窗: 3 months
次要结局
- timing of appearance or worsening of symptoms(3 months)
研究者
Cynthia Corbitt
Associate Professor
University of Louisville
