[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553434":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":37,"centralContacts":42,"locations":50,"responsibleParty":66,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":23,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":23,"overallStatus":53,"whyStopped":23,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Istituto Clinico Humanitas","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Multidisciplinary and innovative approach","EXPERIMENTAL","MRI examination using experimental sequences on 3 Tesla scanner. Neuromotor assessment by an ad-hoc evaluation of the neuromotor skills that includes upper and lower limb assessment.\n\nNeurophysiological Assessment: Motor evoked potential (MEP) and Somatosensory evoked potential (SEP) evaluations.\n\nNeurological and clinical data (including mJOA and Barthel Index) Surgery (if applicable) using a cage in Polyetheretherketone (PEEK) or modern carbon fiber material.",[13,14,15,16],"Diagnostic Test: MRI standard and qMRI","Other: MEPs and SSEPs","Other: Neuromotor assessment","Procedure: Anterior cervical discectomy and fusion",[18,24,28,32],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DIAGNOSTIC_TEST","MRI standard and qMRI","Non-contrast cervical spine MRI including morphological and quantitative MRI sequences on a 3 Tesla scanner. MRI examination includes conventional and experimental sequences",[9],null,{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"MEPs and SSEPs","Neurophysiological examination by motor and somatosensorial evocked potential using transcranial magnetic stimulation and electrical stimulation to the peripheral nerve",[9],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"Neuromotor assessment","Upper and Lower limb assessment: Purdue Pegboard Test (PTT), Box and Block test (BBT), Nine Hole Peg Test (NHPT), gait analysis and 30 seconds sit to stand test (30CST)",[9],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":23},"PROCEDURE","Anterior cervical discectomy and fusion","If applicable: Anterior cervical discectomy and fusion surgery using PEEK or modern carbon fiber material",[9],[38],{"name":39,"affiliation":40,"role":41},"Letterio S POLITI, MD","Humanitas Research Hospital IRCCS, Rozzano-Milan","PRINCIPAL_INVESTIGATOR",[43,47],{"name":39,"role":44,"phone":45,"phoneExt":23,"email":46},"CONTACT","+390282245644","letterio.politi@hunimed.eu",{"name":48,"role":44,"phone":23,"phoneExt":23,"email":49},"Luca A CAPPELLINI, MD","luca.cappellini@humanitas.it",[51],{"facility":52,"status":53,"city":54,"state":23,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"IRCCS Istituto Clinico Humanitas","RECRUITING","Rozzano","20089","Italy","IT",{"type":59,"coordinates":60},"Point",[61,62],9.1559,45.38193,{"lat":62,"lon":61},[65],{"name":39,"role":44,"phone":45,"phoneExt":23,"email":46},{"type":67,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[69],{"name":70,"class":6},"Mediolanum Cardio Research","100553434","quatitative-mri-of-the-spinal-cord-in-cervical-myelopathy-assessment-of-microstuctural-damage-for-outcome-improvement-100553434",false,"NCT06486038","Quatitative MRI of the Spinal Cord in Cervical Myelopathy: Assessment of Microstuctural Damage for Outcome Improvement","QCEMY","Inclusion Criteria:\n\n1. Subjects willing and able to give informed consent for participation in the study.\n2. Age 18-80.\n3. Subjects under evaluation for potential surgical intervention of anterior cervical discectomy and fusion as established by a board-certified neurosurgeon based on clinical and radiological findings according to good clinical practice.\n4. Grade I-III single level sub-axial (C3-C7) cervical spinal canal stenosis (Kang, AJR 2011) on a preliminary anatomical MRI.\n5. Deficitary or irritative cervical spinal cord symptoms and\u002For signs in concordance with MRI findings.\n\nExclusion Criteria:\n\n1. Subjects unable o.r unwilling to give informed consent .\n2. Age \\\u003C18 or \\> 80\n3. Subjects with pacemaker or any other contraindication to undergo high-field (3 Tesla) MRI exam.\n4. Pregnancy or planned pregnancy before the end of the study .\n5. Co-existing or prior neurological disease of the brain, SC, or peripheral nervous system.\n6. Co-existing or prior oncologic disease .\n7. Prior surgery in the brain or spine.","ALL","18 Years","80 Years",{"count":82,"type":83},100,"ESTIMATED","INTERVENTIONAL",[86],"NA","The aim of this low interventional study is to detect microstructural degeneration prior to the presentation, worsening, or persistence following surgical or conservative treatment of cervical degenerative myelopathy signs and symptoms using quantitative imaging metrics and functional biometric analysis.\n\nThe endpoints of the study are to collect and compare the clinical, biometric, neurophysiological and imaging data.\n\nThe objectives of the study are:\n\n* to implement and validate a novel quantitative Magnetic Resonance (qMRI) protocol clinically for the identification and quantification of microstructural spinal cord damage\n* to compare qMRI data to clinical and neuromotor's and corresponding neurophysiological data\n* to create an integrated diagnostic tool for early diagnosis and disease monitoring of myelopathy, and for identification of a more reproducible and quantitative scale for assessing reversible and irreversible spinal cord damage combining clinical, biometric, imaging and neurophysiological data in patients suitable for surgical or non-surgical treatment.\n\nPatient will undergo:\n\n* MRI (baseline - 1 month- 6 months)\n* clinical data collection (baseline- 1 month - 6 months)\n* neuromotor assessment (baseline - 1 month - 6 months)\n* neurophysiological assessment (baseline - 6 months)\n* surgery if applicable Quantitative MRI of the spinal cord could provide a new objective system for identification of patients who require surgery before developing irreversible clinical damage, and to avoid surgical treatment in those who do not require it. Additionally, quantitative MRI, in combination with clinical data such as, neuromotor tests, could provide an important approach to assess the effectiveness of the therapeutical approach.",[89],"Cervical Myelopathy","2024-07-08",{"date":92,"type":93},"2024-07-10","ACTUAL",{"date":95,"type":93},"2024-04-03",{"date":97,"type":83},"2025-05-31",{"name":5,"class":6},1]