Clinical trial NCT06832293: My MS and My Menstrual Cycle
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Menstrual Cycle
Keywords: Multiple Sclerosis
Menstrual Cycle
MS Symptoms
Fatigue
Cognition
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 300
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be female individuals with confirmed diagnosis of Multiple Sclerosis (MS) who experience a regular menstrual cycle.

Brief summary: 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:

1. Does fatigue get worse during certain phases of the menstrual cycle?
2. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Difference in the Modified Fatigue Impact Scale-5 (MFIS-5) Score Across Menstrual Cycle Phases Over Six Months
timeFrame: 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)
Secondary outcomes:
measure: Qualitative Self-Reported Differences in Self-Perceived Cognitive Function Across Menstrual Cycle Phases
timeFrame: 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
measure: Qualitative Self-Reported Differences in Hospital Anxiety and Depression Scale (HADS) Scores
timeFrame: The HADS is assessed at baseline (study entry) and study completion (on average, 6 months later)
measure: Qualitative Self-Reported Difference in Mini-COPE Scores Across Menstrual Cycle Phases
timeFrame: 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)
measure: Qualitative Self-Reported Difference in MFC (Motivation for Cognition) Scores Across Menstrual Cycle Phases
timeFrame: 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)
measure: Qualitative Self-Reported Difference in SymptoMScreen Scores Across Menstrual Cycle Phases
timeFrame: 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)
measure: Qualitative Self-Reported MSNQ (Multiple Sclerosis Neuropsychological Screening Questionnaire) Scores
timeFrame: The MSNQ will be assessed at baseline (study entry) and study completion (on average, 6 months later)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Penny Smyth, MD
role: PRINCIPAL_INVESTIGATOR
References: