[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07723599":3,"trial-entities:NCT07723599":112,"trial-summary:NCT07723599":115},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":42,"sex":69,"minimum_age":70,"maximum_age":71,"healthy_volunteers":15,"eligibility_criteria":72,"std_ages":85,"locations":88,"central_contacts":107,"overall_officials":109,"references":110,"see_also_links":111},"NCT07723599","STUDY00025928","Combating Age-related Failure of Myelination in Multiple Sclerosis: An Exploratory Study","Combating Age-related Failure of Myelination in Multiple Sclerosis: an Exploratory Study","NOT_YET_RECRUITING","2027-07","2026-07","2026-07-23","2026-08","University of Washington","OTHER",false,"This observational, longitudinal study will examine whether physical activity and other potentially modifiable lifestyle factors are associated with changes in myelin, the protective coating around nerve fibers, in older adults with multiple sclerosis (MS). Participants will undergo magnetic resonance imaging (MRI) scans to measure myelin throughout the central nervous system and will wear wrist-worn activity trackers to assess physical activity over time.","The primary aim of this study is to explore clinical variables and potentially modifiable risk factors that are associated with improved myelination (both enhanced remyelination and reduced demyelination) in older adults living with multiple sclerosis. The emphasis here will be on discovery and generation of pilot data to support further definitive longitudinal observational studies, and ultimately, clinical trials on behavioral and\u002For pharmaceutical interventions to prevent demyelination and promote remyelination in people living with MS.\n\nParticipants will be categorized based on whether they meet or exceed the current physical activity guidelines of at least 150 minutes per week of moderate-intensity aerobic physical activity, 75 minutes per week of vigorous-intensity aerobic physical activity, or an equivalent combination.\n\nAt both baseline and 6 months, MRI and clinical assessments will be obtained, and chart review will be performed. Participants will wear a wrist-worn physical activity monitor and answer monthly questionnaires (assessed via REDCap survey) throughout the study period.\n\nLinear regression will be performed to estimate the effect size of various physical activity variables (step count, sedentary time, and time spent in light\u002Fmoderate\u002Fvigorous physical activity, aerobic capacity and overall strength) with 6-month change in myelination.",[19],"Multiple Sclerosis",[21,22,23,24],"remyelination","demyelination","physical activity","multiple sclerosis","OBSERVATIONAL",null,[],{"count":29,"type":30},14,"ESTIMATED",[32],{"type":14,"name":33,"description":34,"armGroupLabels":35},"Observation","No intervention is administered. Participants undergo observational assessments including MRI, wearable activity monitoring, and questionnaires.",[36],"Adults With Multiple Sclerosis",[38],{"measure":39,"description":40,"timeFrame":41},"Quantitative MRI-derived myelin measure","Change in MRI-derived measures of myelin content within the central nervous system. Specifically, the investigators will use macromolecular proton fraction (MPF), a quantitative MRI parameter which describes the magnetization transfer effect and defined as the relative amount of protons bound to biological macromolecules with restricted molecular motion.","Baseline and 6 months",[43,47,51,55,58,62,65],{"measure":44,"description":45,"timeFrame":46},"Total step count","Total step count will measured using wrist-worn activity tracker.","Continuously collected during the 6-month study period",{"measure":48,"description":49,"timeFrame":50},"Self-reported physical activity","Physical activity will be measured with the International Physical Activity Questionnaire-Short Form (IPAQ-SF). This questionnaire will ask participants about their moderate and vigorous physical activity and time spent walking, to give a total sum score of Metabolic Equivalent of Task (MET). Higher calculated (MET) scores indicate greater physical activity.","Baseline and monthly for the 6-month study period",{"measure":52,"description":53,"timeFrame":54},"Multiple Sclerosis Functional Composite (MSFC)","The MSFC assesses walking function, hand function, and cognitive function and gives a composite score.","baseline and 6 months",{"measure":56,"description":57,"timeFrame":41},"Low Contrast Letter Acuity","The LCLA assesses visual function",{"measure":59,"description":60,"timeFrame":61},"Time spent in moderate-to-vigorous physical activity (MVPA)","MVPA will be measured via wrist-worn physical activity monitor","Throughout the 6-month period",{"measure":63,"description":64,"timeFrame":61},"Sedentary Time","Sedentary Time will be measured via wrist-worn fitness tracker",{"measure":66,"description":67,"timeFrame":68},"Self-reported sedentary time","Self-reported sedentary time will be measured with the International Physical Activity Questionnaire-Short Form (IPAQ-SF). This questionnaire will ask participants about their time spent sitting over the past 7 days, as an estimate of sedentary time.","Baseline and monthly throughout the 6-month period","ALL","50 Years","70 Years",{"inclusion":73,"exclusion":79,"raw_text":84},[74,75,76,77,78],"Diagnosis of multiple sclerosis","Independent with ambulation (able to walk 500m without aid)","Disease duration \\>10 years","Age 50 to 70 years (inclusive)","Be able to read, speak, and understand English",[80,81,82,83],"Diagnosis of other neurologic disease that would interfere with interpretation such as stroke, myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), neuromyelitis optica (NMO), and sarcoidosis.","Inability to complete study procedures (including obtaining MRI at BMIC and using Fitbit connected to smartphone)","Currently participating in another clinical trial on remyelination","Pregnancy. (Pregnancy status will be asked at screening and before each MRI. Pregnancy testing will not be offered as part of this study.)","Inclusion Criteria:\n\n* Diagnosis of multiple sclerosis\n* Independent with ambulation (able to walk 500m without aid)\n* Disease duration \\>10 years\n* Age 50 to 70 years (inclusive)\n* Be able to read, speak, and understand English\n\nExclusion Criteria:\n\n* Diagnosis of other neurologic disease that would interfere with interpretation such as stroke, myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), neuromyelitis optica (NMO), and sarcoidosis.\n* Inability to complete study procedures (including obtaining MRI at BMIC and using Fitbit connected to smartphone)\n* Currently participating in another clinical trial on remyelination\n* Pregnancy. (Pregnancy status will be asked at screening and before each MRI. Pregnancy testing will not be offered as part of this study.)",[86,87],"ADULT","OLDER_ADULT",[89],{"facility":90,"city":91,"state":92,"zip":93,"country":94,"contacts":95,"geoPoint":104},"Multiple Sclerosis Center at UW Medical Center - Northwest","Seattle","Washington","98133","United States",[96,101],{"name":97,"role":98,"phone":99,"email":100},"Susan R Robles, BS","CONTACT","206-598-0501","msstudy@uw.edu",{"name":102,"role":103},"Sarah B Simmons, MD, PhD","PRINCIPAL_INVESTIGATOR",{"lat":105,"lon":106},47.60621,-122.33207,[108],{"name":97,"role":98,"phone":99,"email":100},[],[],[],{"nct_id":4,"conditions":113,"biomarkers":114},[19],[],{"nct_id":4,"found":116,"summary":117,"prompt_version":127},true,{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This is an observational study with 14 planned participants. It is not a treatment study, but rather aims to gather information over time.","completed","Observational Study on Myelination in Older Adults with Multiple Sclerosis","This observational study is looking at how physical activity and other lifestyle factors might affect myelin, the protective coating around nerve fibers, in people aged 50 to 70 with multiple sclerosis (MS). You would not receive any new treatments. Instead, researchers will use MRI scans to measure myelin in your brain and spinal cord, and you'll wear a wrist device to track your activity. They want to see if certain lifestyle choices are linked to changes in myelin over six months. The goal is to gather initial information that could lead to future studies on preventing myelin damage and promoting repair in MS. The study plans to include 14 participants, but its current status is unclear.","Your myelin levels will be measured at the start of the study and again at 6 months.",116,"You would have MRI scans and clinical assessments at the beginning and after 6 months. You would also wear a wrist activity monitor and complete monthly questionnaires throughout the study period.","Not stated in the trial record.",[33],"v2"]