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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:
Participants will:
These findings may help researchers better understand MS symptom patterns and improve symptom management.
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| Measure | Description | Time Frame |
|---|---|---|
| Difference in the Modified Fatigue Impact Scale-5 (MFIS-5) Score Across Menstrual Cycle Phases Over Six Months | 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
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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Self-Reported Differences in Self-Perceived Cognitive Function Across Menstrual Cycle Phases | The Cognition Likert Scale measures self-perceived cognitive function in individuals with MS. It consists of two items rated on a 7-point Likert scale:
Each item is interpreted independently. Interpreting the Score: A lower score on the Perceived Cognitive Function scale (e.g., 1-3) suggests greater cognitive impairment, while a higher score (e.g., 5-7) indicates better cognitive function compared to peers. A lower score on the Frequency of Cognitive Difficulties scale (e.g., 1-3) suggests fewer cognitive challenges, while a higher score (e.g., 5-7) indicates more frequent cognitive difficulties. This scale is used to assess cognitive function in individuals with MS, allowing for the identification of self-reported changes in cognition over time. |
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Inclusion Criteria:
Exclusion Criteria:
NMOSD (Neuromyelitis Optica Spectrum Disorder) or MOGAD (Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease)
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The study population will be female individuals with confirmed diagnosis of Multiple Sclerosis (MS) who experience a regular menstrual cycle.
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| Name | Affiliation | Role |
|---|---|---|
| Penny Smyth, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | Canada | |||
| University of Alberta |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 5, 2025 | Mar 7, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 18, 2024 | Feb 6, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 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 Hospital Anxiety and Depression Scale (HADS) measures symptoms of anxiety and depression in individuals with MS. It consists of 14 self-reported items, with 7 items assessing anxiety and 7 items assessing depression over the past week. Each item is rated on a 4-point Likert scale (0-3), with total scores ranging from 0 to 21 for anxiety and 0 to 21 for depression. Interpreting the Score: 0-7: Normal (no significant symptoms) 8-10: Borderline anxiety or depression 11-21: Clinical levels of anxiety or depression Higher scores indicate greater severity of anxiety and/or depression symptoms. The HADS is widely used in clinical and research settings to assess emotional well-being in individuals with chronic conditions like MS. | 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 (MS-Specific Brief COPE) measures coping strategies used in response to stress. The scale assesses problem-focused coping, emotion-focused coping, and maladaptive coping. It consists of 28 self-reported items, each rated on a 4-point Likert scale: 0 = I hardly ever do this
Interpreting the Score:
The Mini-COPE is widely used in MS research to understand coping behaviors and their impact on psychological well-being. | 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 Motivation for Cognition (MFC) Scale measures an individual's motivation to engage in cognitive tasks at a given moment. It consists of 10 self-reported items, each rated on a 7-point Likert scale:
Interpreting the Score:
The MFC Scale will be used to evaluate fluctuations in cognitive motivation over time, particularly in relation to MS symptoms and 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 SymptoMSScreen measures the impact of MS symptoms on daily life and the accommodations individuals make due to these symptoms. The scale evaluates walking, hand function, spasticity, pain, sensory symptoms, bladder control, fatigue, vision, dizziness, cognition, depression, and anxiety. It consists of 12 self-reported items, each rated on a 7-point Likert scale: 0 = No effect at all
Interpreting the Score: - Higher scores indicate greater MS-related disability and symptom burden. The SymptoMSScreen is used in MS research to assess symptom severity and it's impact on daily functioning. It's use will help track symptom progression and variability 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 Multiple Sclerosis Neuropsychological Screening Questionnaire - Patient Version (MSNQ) assesses cognitive and emotional difficulties in individuals with MS. The scale assesses attention, memory, problem-solving, impulse control, and emotional regulation. It consists of 15 self-reported items, each rated on a 5-point Likert scale based on frequency and severity over the past three months: 0 = Never, does not occur
Interpreting the Score: - Higher scores indicate greater cognitive and emotional impairment related to MS. The MSNQ is commonly used in MS research to identify cognitive difficulties and their impact on daily life. The use of MSNQ will help track cognitive fluctuations across menstrual cycle phases. | The MSNQ will be assessed at baseline (study entry) and study completion (on average, 6 months later) |
| Edmonton |
| Alberta |
| Canada |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |