Measuring MS Symptoms in Relation to Menstrual Cycles: Exploring How MS Symptoms May be Affected at Different Times During a Menstrual Cycle in Females Living With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Difference in the Modified Fatigue Impact Scale-5 (MFIS-5) Score Across Menstrual Cycle Phases Over Six Months
研究概览
简要总结
The goal of this observational study is to understand how MS symptoms change during different phases of the menstrual cycle in individuals who menstruate living with MS (Multiple Sclerosis).
The main questions it aims to answer are:
- Does fatigue get worse during certain phases of the menstrual cycle?
- How do symptoms like thinking skills, pain, and mobility change throughout the cycle?
Participants will:
- Use the My Normative app to track their menstrual cycle and MS symptoms.
- Complete symptom check-ins at five points during their cycle for six months.
- Answer questions about fatigue, thinking skills, mood, sleep, and other MS symptoms at the start and end of the study.
These findings may help researchers better understand MS symptom patterns and improve symptom management.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants diagnosed with MS based on the 2024 McDonald Diagnostic criteria (biologically sex-based, any gender as long as not on hormonal gender-enhancing therapy)
- •Aged 16 or older
- •Experiencing menstruation with cycles ranging from 21 to 35 days
- •Have entered menarche, still experiencing menstrual cycles, and have not yet entered menopause
- •May be using hormonal contraceptive methods (e.g., oral contraceptives or hormonal IUDs)
- •Able to speak English
- •Willing to provide informed consent (mature minors will be assessed by their physician for consent eligibility)
- •Able to complete questionnaires and operate the app
排除标准
- •Diagnosed with CNS inflammation disorders other than MS, such as:
- •NMOSD (Neuromyelitis Optica Spectrum Disorder) or MOGAD (Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease)
- •Male or intersex individuals, given the inclusion criteria of requiring a uterus
- •Females under 15 years of age
- •Females who have not started menstruation
- •Females who have stopped menstruation due to menopause or hysterectomy
- •Pregnant or postpartum individuals within one year of delivery,
- •Individuals currently breastfeeding
- •Unable to provide informed consent, or not deemed a mature minor
- •Unable to complete questionnaires and operate the app
结局指标
主要结局
Difference in the Modified Fatigue Impact Scale-5 (MFIS-5) Score Across Menstrual Cycle Phases Over Six Months
时间窗: The MFIS-5 is assessed at baseline (study entry), five key points (menstrual phases) throughout the participant's menstrual cycle every month for 6 months, and study completion (on average, 6 months later)
The Modified Fatigue Impact Scale-5 (MFIS-5) measures the impact of fatigue on cognitive, physical, and psychosocial functions. It uses a 5-point Likert scale for each item, with the following scoring range for each of the 5 items: 0: Never 1. Rarely 2. Sometimes 3. Often 4. Almost Always The total score is the sum of the five items, with a range from 0 to 20. A higher score indicates a greater impact of fatigue on daily functioning. In terms of interpreting the score: A score of 0 would indicate no impact from fatigue. A score of 20 would indicate the maximum possible impact of fatigue on daily functioning. This scale is used to assess fatigue severity in individuals with multiple sclerosis (MS) and other conditions where fatigue is a prominent symptom. A higher score reflects a greater degree of fatigue-related disruption to cognitive, physical, and social tasks.
次要结局
- Qualitative Self-Reported Differences in Self-Perceived Cognitive Function Across Menstrual Cycle Phases(The Cognition Likert Scale is assessed at baseline (study entry) and at five key points (menstrual phases) throughout the participant's menstrual cycle every month for 6 months)
- Qualitative Self-Reported Differences in Hospital Anxiety and Depression Scale (HADS) Scores(The HADS is assessed at baseline (study entry) and study completion (on average, 6 months later))
- Qualitative Self-Reported Difference in Mini-COPE Scores Across Menstrual Cycle Phases(The Mini-COPE is assessed at baseline (study entry), five key points (menstrual phases) throughout the participant's menstrual cycle every month for 6 months, and study completion (on average, 6 months later))
- Qualitative Self-Reported Difference in MFC (Motivation for Cognition) Scores Across Menstrual Cycle Phases(The MFC is assessed at baseline (study entry), five key points (menstrual phases) throughout the participant's menstrual cycle every month for 6 months, and study completion (on average, 6 months later))
- Qualitative Self-Reported Difference in SymptoMScreen Scores Across Menstrual Cycle Phases(The SymptoMScreen is assessed at baseline (study entry), five key points (menstrual phases) throughout the participant's menstrual cycle every month for 6 months, and study completion (on average, 6 months later))
- Qualitative Self-Reported MSNQ (Multiple Sclerosis Neuropsychological Screening Questionnaire) Scores(The MSNQ will be assessed at baseline (study entry) and study completion (on average, 6 months later))