[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531275":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":34,"studyPopulation":23,"armGroups":35,"interventions":48,"overallOfficials":64,"centralContacts":68,"locations":73,"responsibleParty":90,"collaborators":93,"id":96,"slug":23,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":23,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":75,"whyStopped":23,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Kessler Foundation","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":23},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in objective new learning and memory (NLM).","The California Verbal Learning Test-Second Edition (CVLT-II) measures verbal learning and memory by having participants recall a list of words from 4 semantic categories. The word list is presented over 5 trials with a 20 minute delayed recall and recognition trial. Standardized T-scores range from 0-100, where higher scores indicated better performance.","Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)",{"measure":14,"description":15,"timeFrame":12},"Change in everyday memory","The Ecological Memory Simulations (EMS) is a multi-component test that measures memory as it relates to everyday life. Scores range from 0-205, where higher scores indicated better performance.",[17,20],{"measure":18,"description":19,"timeFrame":12},"Change in hippocampal volume","MRI data will be collected in the Rocco Ortenzio Neuroimaging Center at Kessler Foundation using an FDA-approved 3.0 T Siemens Skyra scanner and a 32-channel head coil to measure the volume of bilateral hippocampi.",{"measure":21,"description":22,"timeFrame":12},"Change in hippocampal function","fMRI data will be collected during a list-learning task conducted while in the FDA-approved 3.0 T Siemens Skyra scanner with a 32-channel head coil.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":29,"maskingDescription":30,"whoMasked":31},"DOUBLE","Participants will be blinded to the intent of the two exercise conditions. The outcomes assessor will also be blinded to the random assignment of enrolled participants.",[32,33],"PARTICIPANT","OUTCOMES_ASSESSOR","The proposed research study will be the first to apply the Kessler Foundation modified Story Memory Technique (KF-mSMT®), the practice standard for cognitive rehabilitation, with one of two exercise programs. Alone, KF-mSMT® has been beneficial to NLM impairment, however, its effects are highly selective to list learning and as such, will not maximally restore NLM function. The combination of KF-mSMT® and exercise provides a robust approach towards maximal functional recovery.",[36,43],{"label":37,"type":38,"description":39,"interventionNames":40},"Cognitive Rehabilitation + Aerobic Exercise with Virtual Reality (VR)","EXPERIMENTAL","In the cognitive rehabilitation and aerobic exercise with VR condition, participants will complete a supervised, aerobic exercise training program (AET) integrated with virtual reality (Ideally Designed Exercise to Accelerate Learning\u002Fmemory; IDEAL) three days per week over a 12 week period. For seven weeks, participants will only complete IDEAL. For weeks 8-12, participants will complete the Kessler Foundation modified story Memory Technique (KF-mSMT®), a memory retraining program on 2 of the 3 days per week.",[41,42],"Behavioral: The Kessler Foundation modified Story Memory Technique® (KF-mSMT®)","Behavioral: Aerobic Exercise Training (AET) plus Virtual Reality (IDEAL)",{"label":44,"type":38,"description":45,"interventionNames":46},"Cognitive Rehabilitation + Stretching and Toning","In the cognitive rehabilitation and stretching and toning (S\u002FT) exercise condition, participants will complete 12 weeks of supervised S\u002FT activities 3 days per week over the 12 week period. For seven weeks, participants will only complete S\u002FT. During weeks 8-12, participants will complete the Kessler Foundation modified story Memory Technique (KF-mSMT®), a memory retraining program on 2 of the 3 days per week.",[41,47],"Behavioral: Stretching and Toning (S\u002FT)",[49,54,60],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":23},"BEHAVIORAL","The Kessler Foundation modified Story Memory Technique® (KF-mSMT®)","KF-mSMT is a memory retraining technique that consists of two-related skills: (1) imagery and (2) context\u002Forganization. The proposed KF-mSMT intervention includes 10 total sessions with 2 sessions per week for 5 weeks. Each session will last 45-60 minutes.",[37,44],{"type":50,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Aerobic Exercise Training (AET) plus Virtual Reality (IDEAL)","The AET condition includes 12 weeks of supervised, progressive, moderate intensity cycle ergometry. The AET will include semi-immersive, interactive VR such the cycling speed on the bike will translate directly to perceived speed through the virtual environment.",[37],[59],"IDEAL",{"type":50,"name":61,"description":62,"armGroupLabels":63,"otherNames":23},"Stretching and Toning (S\u002FT)","The S\u002FT condition will include 12 weeks of supervised S\u002FT activities that target the head\u002Fneck. shoulder, elbow\u002Fforearm, hand\u002Fwrist, trunk\u002Fhip, ankle\u002Ffoot.",[44],[65],{"name":66,"affiliation":5,"role":67},"Carly Wender, PhD","PRINCIPAL_INVESTIGATOR",[69],{"name":66,"role":70,"phone":71,"phoneExt":23,"email":72},"CONTACT","(973) 324-8388","cwender@kesslerfoundation.org",[74],{"facility":5,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"RECRUITING","East Hanover","New Jersey","07936","United States","US",{"type":82,"coordinates":83},"Point",[84,85],-74.36487,40.8201,{"lat":85,"lon":84},[88],{"name":66,"role":70,"phone":89,"phoneExt":23,"email":72},"9732436984",{"type":67,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Carly Wender","Research Scientist",[94],{"name":95,"class":6},"National Multiple Sclerosis Society","100531275",false,"NCT06197685","A Novel Combinatory Approach to Maximize Functional Recovery of Learning and Memory in Multiple Sclerosis","COMBINE","Inclusion Criteria:\n\n* Be within the ages of 18 and 70 years of age\n* Speak English as their primary language\n* Confirmed MS diagnosis by a neurologist\n* Be relapse and steroid-free for at least 30 days\n* Mild-to-moderate self-reported mobility disability, based on the Patient Determined Disease Steps scale (PDDS)\n* Currently physically inactive, based on the Godin Leisure Time Exercise Questionnaire (GLTEQ)\n* Right handedness\n\nExclusion Criteria:\n\n* History of neurological disorders besides MS or history of uncontrolled psychiatric disorders (ex: major depression)\n* Have contraindications to exercise, based on the Physical Activity Readiness Questionnaire (PAR-Q)\n* Currently use medications that may impact cognition (ex: steroids, benzodiazepines)\n* Currently pregnant\n* Contraindication for MRI (metal or electronic devices in the body that are not considered MRI safe)\n* Severe cognitive impairment as measured by the Modified Telephone Interview of Cognitive Status (TICS-M)","ALL","18 Years","70 Years",{"count":106,"type":107},78,"ESTIMATED","INTERVENTIONAL",[110],"NA","The goal of this novel study is to compare the effect of a combined cognitive rehabilitation and exercise approach on new learning and memory (NLM) in persons with multiple sclerosis (pwMS) and mobility disability.",[113],"Multiple Sclerosis",[113,115,116,117,118],"Aerobic exercise","Virtual Reality","Leg cycling","Mobility disability","2025-08-25",{"date":121,"type":122},"2025-09-02","ACTUAL",{"date":124,"type":122},"2024-02-12",{"date":126,"type":107},"2026-06-30",{"name":5,"class":6},1]