Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-27 @ 11:22 PM
Study NCT ID:
NCT07081594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-23
First Post:
2025-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Impact of Sex Hormones in Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2025-06-17', 'studyFirstSubmitQcDate': '2025-07-22', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corticospinal excitability', 'timeFrame': "At 3 points during the individual's 1-month menstrual cycle, 1) Early Follicular 2) Late Follicular 3) Luteal", 'description': 'Measuring the brain to muscle connection using transcranial magnetic stimulation - a non-invasive way to measure brain activity. Peak to Peak amplitude in mV is recorded'}, {'measure': 'Blood Draw', 'timeFrame': "At 3 points during the individual's 1-month menstrual cycle, 1) Early Follicular 2) Late Follicular 3) Luteal", 'description': 'To quantify estradiol and progesterone levels. Normative values of estradiol (E) and progesterone (P) per phase: early follicular (E: 125pmol/L; P: 0.38nmol/L), late follicular (E: 464pmol/L; P: 0.188nmol/L), luteal (E: 412pmol/L; P: 28.8nmol/L)'}], 'secondaryOutcomes': [{'measure': 'strength', 'timeFrame': "At 3 points during the individual's 1-month menstrual cycle, 1) Early Follicular 2) Late Follicular 3) Luteal", 'description': 'Measured by a pinch maximal voluntary contraction in lb-f'}, {'measure': 'Fatigue', 'timeFrame': "At 3 points during the individual's 1-month menstrual cycle, 1) Early Follicular 2) Late Follicular 3) Luteal", 'description': 'Measured with a pinch fatiguing task to estimate how quickly muscle of the hand fatigues. Measured in Seconds'}, {'measure': 'Motor Learning', 'timeFrame': "At 3 points during the individual's 1-month menstrual cycle, 1) Early Follicular 2) Late Follicular 3) Luteal", 'description': 'A visuomotor tracking task to measure difference between target trace and performed trace, measured in root mean squared error'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Sex hormones', 'menstrual cycle'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '35963205', 'type': 'BACKGROUND', 'citation': "Christogianni A, O'Garro J, Bibb R, Filtness A, Filingeri D. Heat and cold sensitivity in multiple sclerosis: A patient-centred perspective on triggers, symptoms, and thermal resilience practices. Mult Scler Relat Disord. 2022 Nov;67:104075. doi: 10.1016/j.msard.2022.104075. Epub 2022 Jul 25."}, {'pmid': '27845228', 'type': 'BACKGROUND', 'citation': 'Karim HT, Huppert TJ, Erickson KI, Wollam ME, Sparto PJ, Sejdic E, VanSwearingen JM. Motor sequence learning-induced neural efficiency in functional brain connectivity. Behav Brain Res. 2017 Feb 15;319:87-95. doi: 10.1016/j.bbr.2016.11.021. Epub 2016 Nov 11.'}, {'pmid': '36914263', 'type': 'BACKGROUND', 'citation': 'Casamento-Moran A, Mooney RA, Chib VS, Celnik PA. Cerebellar Excitability Regulates Physical Fatigue Perception. J Neurosci. 2023 Apr 26;43(17):3094-3106. doi: 10.1523/JNEUROSCI.1406-22.2023. Epub 2023 Mar 13.'}, {'type': 'BACKGROUND', 'citation': 'Hackney AC, ed. Sex Hormones, Exercise and Women: Scientific and Clinical Aspects. 1st ed. 2017. Springer International Publishing : Imprint: Springer; 2017. doi:10.1007/978-3-319-44558-81'}, {'pmid': '32719651', 'type': 'BACKGROUND', 'citation': 'Gilli F, DiSano KD, Pachner AR. SeXX Matters in Multiple Sclerosis. Front Neurol. 2020 Jul 3;11:616. doi: 10.3389/fneur.2020.00616. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'Emerging evidence indicates that females with MS experience worsened symptoms during the luteal phase (post ovulation) of the menstrual cycle when progesterone levels rise and estradiol fluctuate. The rapid hormonal swings may disrupt hypothalamic regulation, leading to an increase in body temperature - a well-established trigger for MS symptom exacerbation. These hormonal changes could also affect neuromuscular function, as estradiol and progesterone receptors are present in the nervous system and skeletal muscles.\n\nThree critical aspects of motor rehabilitation are corticospinal excitability, motor learning, and fatigability. Previous research indicates that corticospinal excitability and the capacity to learn fine motor tasks fluctuate across menstrual cycles, indicating hormonal influences on neuroplasticity. However, it remains unclear how these hormonal fluctuations specifically affect corticospinal excitability, motor learning, and motor fatigability in females with MS. Understanding these relationships could significantly improve rehabilitation approaches. For example, pre-menopause females with MS may experience a more optimal state for neuroplasticity during the follicular phase of their cycles, therefore providing a potential window for greater rehabilitation efficacy.', 'detailedDescription': 'The objective of this project is to systematically examine how hormonal fluctuations pre-menopause influence corticospinal excitability, motor learning, and motor fatigability in females with MS. The study is structured around the following specific aims:\n\nAim 1: Quantify the effects of estradiol and progesterone levels on corticospinal excitability in pre- menopausal females with MS. We will elicit motor evoked potentials by cortical and subcortical stimulation of corticospinal axons using transcranial magnetic stimulation (TMS).\n\nAim 2: Evaluate how hormonal fluctuations across menstrual phases impact motor learning ability in pre-menopause females with MS. Participants will be asked to perform a finger sequence motor learning task using visual feedback. The task will be performed using a computer keyboard. Participants will be asked to copy the numerical sequence on a monitor in front of them that pertains to a number on the keyboard with their fingers. Participants will be given three different sequences with equivalent difficulty at each session to avoid carry-over effects between visits.\n\nAim 3: Determine the relationship between hormonal fluctuations and motor fatigability in pre-menopause females with MS. Participants will perform a maximal voluntary force (MVF). Participants will then be asked to pinch to 80% of their MVF, and maintain this hold for as long as possible1. The trial will end when the force drops below 40% MVF. Two trials in total will be performed. Average time to fatigue (40% MVF) and slope of the drop-off will be calculated as a measure of overall fatigue.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Persons with menstrual cycles and any form of multiple sclerosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of relapsing-remitting, primary progressive or secondary progressive MS with no minimum years since diagnosis\n* Stable disease modifying therapies for at least 6 months\n* Eumenorrheic females\n\nExclusion Criteria:\n\n* Another diagnosis (e.g., peripheral neuropathies or orthopedic)\n* Pregnancy as confirmed by urine test\n* Irregular menstrual cycles\n* Diagnosis of premenstrual dysphoric disorder or polycystic ovary syndrome\n* Taking antipsychotic medications / does not pass the TMS safety checklist'}, 'identificationModule': {'nctId': 'NCT07081594', 'briefTitle': 'Investigating the Impact of Sex Hormones in Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Shirley Ryan AbilityLab'}, 'officialTitle': 'Investigating the Impact of Sex Hormones on Corticospinal Excitability, Motor Learning, and Fatigue in Females With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'STU00224323'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pre-Menopausal Women', 'description': 'Naturally cycling women with multiple sclerosis'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kailynn Mannella, PhD', 'role': 'CONTACT', 'email': 'kmannella@sralab.org', 'phone': '312-238-6493'}, {'name': 'Milap Sandhu, PT, PhD', 'role': 'CONTACT', 'email': 'msandhu@sralab.org'}], 'overallOfficials': [{'name': 'Milap Sandhu, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shirley Ryan AbilityLab'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Following IRB approval, documents will be available', 'ipdSharing': 'YES', 'description': 'De-Identified data will be available after completion of the study upon request', 'accessCriteria': 'These data will be available upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milap Sandhu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Milap Sandhu', 'investigatorAffiliation': 'Shirley Ryan AbilityLab'}}}}