Nctid:
NCT06611280
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009103", "term"=>"Multiple Sclerosis"}, {"id"=>"D000012598", "term"=>"Sclerosis"}], "ancestors"=>[{"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000020278", "term"=>"Demyelinating Autoimmune Diseases, CNS"}, {"id"=>"D000020274", "term"=>"Autoimmune Diseases of the Nervous System"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000003711", "term"=>"Demyelinating Diseases"}, {"id"=>"D000001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M12060", "name"=>"Multiple Sclerosis", "asFound"=>"Multiple Sclerosis", "relevance"=>"HIGH"}, {"id"=>"M15415", "name"=>"Sclerosis", "asFound"=>"Sclerosis", "relevance"=>"HIGH"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M22098", "name"=>"Demyelinating Autoimmune Diseases, CNS", "relevance"=>"LOW"}, {"id"=>"M22094", "name"=>"Autoimmune Diseases of the Nervous System", "relevance"=>"LOW"}, {"id"=>"M6909", "name"=>"Demyelinating Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"CROSS_SECTIONAL", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>20}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-08", "completionDateStruct"=>{"date"=>"2026-05-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-20", "studyFirstSubmitDate"=>"2024-09-03", "studyFirstSubmitQcDate"=>"2024-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-24", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-10-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"lactate to glx ratio", "timeFrame"=>"2 hours from enrollment to end of assessment", "description"=>"Brain deuterium metabolic imaging determined lactate to glx ratio"}], "secondaryOutcomes"=>[{"measure"=>"Six-minute walk test", "timeFrame"=>"3 hours from enrollment to end of assessment", "description"=>"Measure of walking capacity as meters walking in six minutes"}, {"measure"=>"25 meter walk test", "timeFrame"=>"3 hours from enrollment to end of assessment", "description"=>"Maximal and usual walking speed over 25 feet including a 3 m measurement"}, {"measure"=>"Six-spot-step-test", "timeFrame"=>"3 hours from enrollment to end of assessment", "description"=>"Fastes time to kick six block away from six markings on the floor approximatly 1 meter from another in a zig-zag patteren."}, {"measure"=>"Handgrip strength", "timeFrame"=>"3 hours from enrollment to end of assessment", "description"=>"Handgrip dynamometry"}, {"measure"=>"5-sit-to-stand", "timeFrame"=>"3 hours from enrollment to end of assessment", "description"=>"Time to perform five sit to stand."}, {"measure"=>"Processing speed - Selective reminding test", "timeFrame"=>"3 hours from enrollment to end of assessment", "description"=>"Symbol digit modality test, number of symbols translated in 90 s"}, {"measure"=>"Memory function - Symbol digit modality test", "timeFrame"=>"3 hours from enrollment to end of assessment", "description"=>"Symbol digit modality test\n\n* Short term memory\n* consistence short term memory\n* long-term memory"}, {"measure"=>"Glukose level", "timeFrame"=>"3 hours from enrollment to end of assessment", "description"=>"From blood sample"}, {"measure"=>"Lactat level", "timeFrame"=>"3 hours from enrollment to end of assessment", "description"=>"From blood sample"}, {"measure"=>"Glucose uptake", "timeFrame"=>"2 hours from enrollment to end of assessment", "description"=>"Brain deuterium metabolic imaging demined glucose uptake measured by glucose to DHO + glucose ratio"}, {"measure"=>"glucose to glx ratio", "timeFrame"=>"2 hours from enrollment to end of assessment", "description"=>"Brain deuterium metabolic imaging demined glucose to glx ratio"}, {"measure"=>"Clinical information on multiple sclerosis - Disease modifying treatment", "timeFrame"=>"7 days from enrollment to end of assessment", "description"=>"Information on current disease modifying treatment are exacted from the hospital patient record"}, {"measure"=>"Clinical information on multiple sclerosis - Time since diagnosis", "timeFrame"=>"7 days from enrollment to end of assessment", "description"=>"Information on time since diagnosis are exacted from the hospital patient record"}, {"measure"=>"Modified Fatigue Impact Scale", "timeFrame"=>"7 days from enrollment to end of assessment", "description"=>"A 29-item questionnaire measuring the impact of multiple sclerosis on the patient. With a minimum score of 29 and a maximum of 116, a higher score indicates a worse outcome."}, {"measure"=>"Clinical information on multiple sclerosis - Expanded disability status score", "timeFrame"=>"7 days from enrollment to end of assessment", "description"=>"Information on expanded disability status score is exacted from the hospital patient record. The expanded disability status score is a physician rating of disease severity from 0-10 with a higher score indicating higher disability."}, {"measure"=>"Multiple Sclerosis Impact Scale", "timeFrame"=>"7 days from enrollment to end of assessment", "description"=>"A 21-item questionnaire measuring the impact of multiple sclerosis on the patient. With a minimum score of 0 and a maximum of 84, a higher score indicates a worse outcome."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Multiple Sclerosis (MS) - Relapsing-remitting"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this case-control study is to investigate glucose brain metabolism in people with multiple sclerosis and age- and sex-matched healthy controls. The main questions it aims to answer are:\n\n* How does brain glucose metabolism in people with multiple sclerosis compare to age- and sex-matched healthy controls?\n* How is the brain glucose metabolism of people with multiple sclerosis associated with disease severity?\n\nParticipants will come in for testing lasting approximately three hours and undergo deuterium metabolic imaging, physical function test, cognitive function test, and answer survey."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"The study seeks to include people with relapsing remitting multiple sclerosis that are otherwise healthy and age- and sex-matched healthy control participants.", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Aged 18-60 years.\n* Definite Relapsing remitting multiple sclerosis diagnosis according to the most recent diagnostic criteria\n\nExclusion Criteria:\n\n* Contraindications for MRI:\n\nPacemaker, neurostimulator or cholera implant. Metal foreign bodies such as fragments and irremovable piercings. Unsafe medical implants (safety of heart valves, hips and the like must be confirmed).\n\nClaustrophobia. Largest circumference including arms \\> 160 cm\n\n* Pregnancy\n* Competing neurological, psychiatric, or systemic diseases including diabetes (except prior TIA, unspecific brain MRI findings, hypertension, atherosclerosis and hyperlipidemia/cholesterolemia which are allowed).\n* Participating in other clinical trials with investigational medical products or drugs."}, "identificationModule"=>{"nctId"=>"NCT06611280", "briefTitle"=>"Deuterium Metabolic Imaging in People with Multiple Sclerosis", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Aarhus"}, "officialTitle"=>"Deuterium Metabolic Imaging in People with Multiple Sclerosis", "orgStudyIdInfo"=>{"id"=>"DMI in MS"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"MS group", "description"=>"People with relapse remitting multiple sclerosis", "interventionNames"=>["Other: No Interventions"]}, {"label"=>"HC group", "description"=>"Healthy control participant who are age- and sex-matched to the MS group", "interventionNames"=>["Other: No Interventions"]}], "interventions"=>[{"name"=>"No Interventions", "type"=>"OTHER", "description"=>"No delivered intervention.", "armGroupLabels"=>["HC group", "MS group"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Tobias Gæmelke, PhD-stud", "role"=>"CONTACT", "email"=>"gaemelke@ph.au.dk", "phone"=>"4528264508"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"Due to the European Unions General Data Protection Regulation."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Aarhus", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
