RecruitingNCT06832293

My MS and My Menstrual Cycle

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


Sponsor

University of Alberta

Enrollment

300 participants

Start Date

Feb 19, 2025

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 16 Years

Inclusion Criteria15

  • 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
  • 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

Exclusion Criteria2

  • Diagnosed with CNS inflammation disorders other than MS, such as:
  • NMOSD (Neuromyelitis Optica Spectrum Disorder) or MOGAD (Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease)

Locations(2)

University of Calgary

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

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NCT06832293


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