Nctid:
NCT06226324
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001930", "term"=>"Brain Injuries"}, {"id"=>"D000008180", "term"=>"Lupus Erythematosus, Systemic"}], "ancestors"=>[{"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000006259", "term"=>"Craniocerebral Trauma"}, {"id"=>"D000020196", "term"=>"Trauma, Nervous System"}, {"id"=>"D000014947", "term"=>"Wounds and Injuries"}, {"id"=>"D000003240", "term"=>"Connective Tissue Diseases"}, {"id"=>"D000001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M5207", "name"=>"Brain Injuries", "asFound"=>"Brain Injury", "relevance"=>"HIGH"}, {"id"=>"M11177", "name"=>"Lupus Erythematosus, Systemic", "asFound"=>"Systemic Lupus Erythematosus", "relevance"=>"HIGH"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}, {"id"=>"M9349", "name"=>"Craniocerebral Trauma", "relevance"=>"LOW"}, {"id"=>"M22023", "name"=>"Trauma, Nervous System", "relevance"=>"LOW"}, {"id"=>"M6464", "name"=>"Connective Tissue Diseases", "relevance"=>"LOW"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>120}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-25", "studyFirstSubmitDate"=>"2024-01-09", "studyFirstSubmitQcDate"=>"2024-01-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-06", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus", "timeFrame"=>"2 years", "description"=>"Early identification of specific brain areas of brain injury in lupus patients by fMRI provides objective imaging markers for early clinical intervention."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Systemic Lupus Erythematosus"]}, "descriptionModule"=>{"briefSummary"=>"Systemic lupus erythematosus (SLE) is a chronic autoimmune disease involving multiple organs and systems. The central nervous system is one of the most commonly involved parts, and the involvement of the nervous system is called neuropsychiatric lupus, which is one of the most common complications of SLE and the main cause of death. Cognitive impairment and emotional disorders are the most common neuropsychiatric symptoms, with a prevalence of up to 80%. Studies have shown that the prevalence of NPSLE is between 37% and 95%. Compared with SLE patients, the mortality rate increases by three times. Early diagnosis and treatment play an important role in improving the quality of life of patients. fMRI has the advantages of non-invasive, in vivo and high repeatability, and can detect the brain function changes of patients early before the structural changes. This study uses fMR to compare the differences in brain function changes between SLE patients and healthy controls, explore the neuroimaging mechanism of brain injury, and provide reference for the early clinical intervene.", "detailedDescription"=>"The fMRI images of 40 SLE patients with neuropsychiatric symptoms, 40 SLE patients without neuropsychiatric symptoms and 40 healthy controls matched by sex, age and education level were collected. fMRI was selected as an evaluation method to compare the differences in brain functional changes among the three groups, and to explore the specific brain regions in the imaging of early brain injury in SLE. Neurocognitive assessment was performed on all subjects, clinical data and laboratory serum markers of SLE patients were collected, and the correlation between SLE patients and specific brain regions was analyzed, and multiple regression models were constructed to provide imaging references for early clinical diagnosis and intervention in the process of NPSLE."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT"], "maximumAge"=>"55 years", "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"There were 80 SLE patients (40 with and without neuropsychiatric symptoms) and 40 healthy controls", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Age and gender matched the case group\n2. Right-handed\n3. No cerebrovascular, neurological or mental diseases\n4. Can cooperate with MRI and neuropsychiatric examination\n\nExclusion Criteria:\n\n1. Patients with serious diseases of other systems\n2. Patients with diseases of central nervous system\n3. Other rheumatic immune system diseases\n4. Neuropsychiatric history\n5. Smokers, drug users or alcoholics\n6. Contraindicated MRI"}, "identificationModule"=>{"nctId"=>"NCT06226324", "briefTitle"=>"fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus", "organization"=>{"class"=>"OTHER", "fullName"=>"The Affiliated Hospital of Inner Mongolia Medical University"}, "officialTitle"=>"fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus", "orgStudyIdInfo"=>{"id"=>"AHInnerMongolia-SLE"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"SLE with neuropsychiatric symptoms", "description"=>"1. Neuropsychiatric symptoms meeting the 1999 ACR definition\n2. Ages 18-55y\n3. Female\n4. Right-handed\n5. Can cooperate with MRI and neuropsychiatric examination", "interventionNames"=>["Other: neuropsychological test"]}, {"label"=>"SLE without neuropsychiatric symptoms", "description"=>"1. Patients who meet the 2019 ACR diagnostic criteria for SLE\n2. Patients without neuropsychiatric symptoms\n3. Age 18-55y\n4. Female\n5. Right-handed\n6. Able to cooperate with MRI and neuropsychiatric examination", "interventionNames"=>["Other: neuropsychological test"]}, {"label"=>"Healthy control group", "description"=>"1. Age and gender matched the case group\n2. Right-handed\n3. No cerebrovascular, neurological or mental diseases\n4. Can cooperate with MRI and neuropsychiatric examination", "interventionNames"=>["Other: neuropsychological test"]}], "interventions"=>[{"name"=>"neuropsychological test", "type"=>"OTHER", "description"=>"The subjects were evaluated for memory, cognition, mood and sleep", "armGroupLabels"=>["Healthy control group", "SLE with neuropsychiatric symptoms", "SLE without neuropsychiatric symptoms"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Hohhot", "state"=>"Inner Mongolia", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Peng fei Qiao", "role"=>"CONTACT", "email"=>"24853170@qq.com", "phone"=>"15904718239"}, {"name"=>"Peng fei Qiao", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Affiliated Hospital of Inner Mongolia Medical University", "geoPoint"=>{"lat"=>40.81056, "lon"=>111.65222}}], "centralContacts"=>[{"name"=>"Peng fei Qiao", "role"=>"CONTACT", "email"=>"24853170@qq.com", "phone"=>"15904718239"}], "overallOfficials"=>[{"name"=>"Peng fei Qiao", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Affiliated Hospital of Inner Mongolia Medical University"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"The Affiliated Hospital of Inner Mongolia Medical University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
