Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT06832293
Status:
RECRUITING
Last Update Posted:
2025-03-26
First Post:
2025-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
My MS and My Menstrual Cycle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-03-05', 'size': 539957, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-07T11:40', 'hasProtocol': True}, {'date': '2024-10-18', 'size': 263964, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-02-06T16:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2025-02-06', 'studyFirstSubmitQcDate': '2025-02-12', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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)", 'description': '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:\n\n0: Never\n\n1. Rarely\n2. Sometimes\n3. Often\n4. 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.\n\nIn terms of interpreting the score:\n\nA score of 0 would indicate no impact from fatigue. A score of 20 would indicate the maximum possible impact of fatigue on daily functioning.\n\nThis 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.'}], 'secondaryOutcomes': [{'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", 'description': '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:\n\n1. Perceived Cognitive Function Compared to Peers (ex. 1 = Severely worse, 4 = Unchanged, 7 = Significantly better).\n2. Frequency of Cognitive Difficulties (ex. 1 = Never, 4 = Sometimes, 7 = All the time).\n\nEach item is interpreted independently.\n\nInterpreting the Score:\n\nA 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.\n\nA 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.\n\nThis scale is used to assess cognitive function in individuals with MS, allowing for the identification of self-reported changes in cognition over time.'}, {'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)', 'description': '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.\n\nEach 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.\n\nInterpreting the Score:\n\n0-7: 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.'}, {'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)", 'description': '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\n\nLikert scale:\n\n0 = I hardly ever do this\n\n1. = I rarely do this\n2. = I do this often\n3. = I almost always do this\n\nInterpreting the Score:\n\n* Higher scores indicate more frequent use of a specific coping strategy.\n* Individual scores provide insight into which coping mechanisms are most commonly used in response to stress.\n\nThe Mini-COPE is widely used in MS research to understand coping behaviors and their impact on psychological well-being.'}, {'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)", 'description': "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:\n\n* 3 = Very strongly does not apply to me\n* 2 = Strongly does not apply to me\n* 1 = Somewhat does not apply to me 0 = Neutral\n\n * 1 = Somewhat applies to me\n * 2 = Strongly applies to me\n * 3 = Very strongly applies to me\n\nInterpreting the Score:\n\n* Higher scores indicate greater motivation for engaging in cognitive tasks.\n* Lower scores suggest reduced interest in or avoidance of cognitively demanding activities.\n\nThe MFC Scale will be used to evaluate fluctuations in cognitive motivation over time, particularly in relation to MS symptoms and menstrual cycle phases."}, {'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)", 'description': "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:\n\n0 = No effect at all\n\n1. = Very mild limitation\n2. = Mild limitation\n3. = Moderate limitation\n4. = Severe limitation\n5. = Very severe limitation\n6. = Total limitation\n\nInterpreting the Score:\n\n\\- Higher scores indicate greater MS-related disability and symptom burden.\n\nThe 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."}, {'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)', 'description': '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:\n\n0 = Never, does not occur\n\n1. = Very rarely, no problem\n2. = Occasionally, seldom a problem\n3. = Quite often, interferes with life\n4. = Very often, very disruptive\n\nInterpreting the Score:\n\n\\- Higher scores indicate greater cognitive and emotional impairment related to MS.\n\nThe 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Menstrual Cycle', 'MS Symptoms', 'Fatigue', 'Cognition'], 'conditions': ['Multiple Sclerosis', 'Menstrual Cycle']}, 'descriptionModule': {'briefSummary': '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).\n\nThe main questions it aims to answer are:\n\n1. Does fatigue get worse during certain phases of the menstrual cycle?\n2. How do symptoms like thinking skills, pain, and mobility change throughout the cycle?\n\nParticipants will:\n\n* Use the My Normative app to track their menstrual cycle and MS symptoms.\n* Complete symptom check-ins at five points during their cycle for six months.\n* Answer questions about fatigue, thinking skills, mood, sleep, and other MS symptoms at the start and end of the study.\n\nThese findings may help researchers better understand MS symptom patterns and improve symptom management.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be female individuals with confirmed diagnosis of Multiple Sclerosis (MS) who experience a regular menstrual cycle.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* Aged 16 or older\n* Experiencing menstruation with cycles ranging from 21 to 35 days\n* Have entered menarche, still experiencing menstrual cycles, and have not yet entered menopause\n* May be using hormonal contraceptive methods (e.g., oral contraceptives or hormonal IUDs)\n* Able to speak English\n* Willing to provide informed consent (mature minors will be assessed by their physician for consent eligibility)\n* Able to complete questionnaires and operate the app\n\nExclusion Criteria:\n\n* Diagnosed with CNS inflammation disorders other than MS, such as:\n\nNMOSD (Neuromyelitis Optica Spectrum Disorder) or MOGAD (Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease)\n\n* Male or intersex individuals, given the inclusion criteria of requiring a uterus\n* Females under 15 years of age\n* Females who have not started menstruation\n* Females who have stopped menstruation due to menopause or hysterectomy\n* Pregnant or postpartum individuals within one year of delivery,\n* Individuals currently breastfeeding\n* Unable to provide informed consent, or not deemed a mature minor\n* Unable to complete questionnaires and operate the app'}, 'identificationModule': {'nctId': 'NCT06832293', 'briefTitle': 'My MS and My Menstrual Cycle', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Pro00140591'}}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sarah Morrow, MD', 'role': 'CONTACT', 'email': 'calgarymsresearch@ucalgary.ca', 'phone': '403-944-4187'}, {'name': 'Dr. Sarah Morrow', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Penny Smyth, MD', 'role': 'CONTACT', 'email': 'smyth@ualberta.ca', 'phone': '780-248-1775'}, {'name': 'Dr. Penny Smyth', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Penny Smyth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}