[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545424":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":46,"centralContacts":50,"locations":55,"responsibleParty":72,"collaborators":75,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":35,"eligibilityCriteria":83,"healthyVolunteers":80,"sex":84,"minAge":85,"maxAge":35,"enrollmentInfo":86,"targetDuration":35,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":58,"whyStopped":35,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"University of Milan","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Spontaneous motor reorganization: observation","ACTIVE_COMPARATOR","Only neurological and neuropsychological assessment as per normal clinical routine and conventional and advanced functional, resting-state MRI acquisitions",[13],"Diagnostic Test: Resting State Functional Magnetic Resonance Imaging (rs-fMRI)",{"label":15,"type":16,"description":17,"interventionNames":18},"Enhanced motor reorganization: upfront Motor Rehabilitation","EXPERIMENTAL","Patients submitted to motor rehabilitation program aimed at learning unimanual and bimanual coordinated sequences, along with personalized exercise according to tumor location (frontal vs parietal). For 6 months each patient will perform the motor training program in outpatient training session, checked by a physiotherapist for corrected execution at home 3 times\u002Fweek, and is assessed for the correct training execution and progresses in training sessions each month, by physical therapists at the Rehabilitation Unit and on a weekly schedule by on-line distant monitoring (telemedicine).",[19],"Behavioral: Up-front Motor Rehabilitation",{"label":21,"type":16,"description":22,"interventionNames":23},"Enhanced motor reorganization: upfront Chemotherapy","Temozolomide-based regimen of 6 months duration is applied. Treatment will be discontinued in case of toxicity (G2-G4).",[24],"Drug: Up-front Chemotherapy",{"label":26,"type":16,"description":27,"interventionNames":28},"Enhanced motor reorganization: upfront Chemotherapy + Motor Rehabilitation","Temozolomide-based regimen of 6 months duration is applied. Treatment will be discontinued in case of toxicity (G2-G4).\n\nPatients will also be submitted to motor rehabilitation program aimed at learning unimanual and bimanual coordinated sequences, along with personalized exercise according to tumor location (frontal vs parietal). For 6 months each patient will perform the motor training program in outpatient training session, checked by a physiotherapist for corrected execution at home 3 times\u002Fweek, and is assessed for the correct training execution and progresses in training sessions each month, by physical therapists at the Rehabilitation Unit and on a weekly schedule by on-line distant monitoring (telemedicine).",[19,24],[30,36,41],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DIAGNOSTIC_TEST","Resting State Functional Magnetic Resonance Imaging (rs-fMRI)","rs-fMRI + neurological and neuropsychological evaluation at preoperative timepoint and 1-2 months postop, 3-4 months postop, 6-8 months postop, 12 months postop",[9],null,{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":35},"BEHAVIORAL","Up-front Motor Rehabilitation","personalized motor rehabilitation for 6 months + rs-fMRI + neurological and neuropsychological evaluation before starting motor rehabilitation, at 2-3 months during rehabilitation, 6-9 months during rehabilitation, before surgery (if surgery indicated by tumour board), 1 month postop, 2-3 months postop",[26,15],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":35},"DRUG","Up-front Chemotherapy","Temozolomide at either 6 cycles consisting of 150-200 mg per square meter for 5 days during each 28-day cycle, or metronomic schedule, + rs-fMRI + neurological and neuropsychological evaluation before starting motor rehabilitation, at 2-3 months during rehabilitation, 6-9 months during rehabilitation, before surgery (if surgery indicated by tumour board), 1 month postop, 2-3 months Post",[21,26],[47],{"name":48,"affiliation":5,"role":49},"Lorenzo Bello, MD","PRINCIPAL_INVESTIGATOR",[51],{"name":48,"role":52,"phone":53,"phoneExt":35,"email":54},"CONTACT","0039-340-217-1453","lorenzo.bello@unimi.it",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"IRCCS Ospedale Galeazzi Sant'Ambrogio","RECRUITING","Milan","Lombardy","20157","Italy","IT",{"type":65,"coordinates":66},"Point",[67,68],9.18951,45.46427,{"lat":68,"lon":67},[71],{"name":48,"role":52,"phone":53,"phoneExt":35,"email":54},{"type":49,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Lorenzo Bello","Full Professor",[76],{"name":77,"class":6},"University of Turin, Italy","100545424","personalized-rendering-of-motor-system-functional-plasticity-potential-to-improve-glioma-resection-and-quality-of-life-100545424",false,"NCT06381726","Personalized Rendering of Motor System Functional Plasticity Potential to Improve Glioma Resection and Quality of Life","Inclusion Criteria (ARM 1):\n\n* Patients signing informed consent for participation in the study\n* Males and females\n* Age ≥ 18 years\n* Patients with lower-grade gliomas with involvement of the motor pathways who are candidates for surgery\n\nInclusion Criteria (ARM 2\u002F3\u002F4):\n\n* Patients signing informed consent for participation in the study\n* Males and females\n* Age ≥ 18 years\n* Patients with lower-grade gliomas treated over two years with tumors only biopsied and\u002For partially resected and eligible for second surgery\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Inability to adhere to standard study controls\n* Subjects unable to understand and freely provide consent to the study","ALL","18 Years",{"count":87,"type":88},400,"ESTIMATED","INTERVENTIONAL",[91],"NA","Background Lower-grade-gliomas affect young patients, thus the longest progression-free-survival (PFS) with a high level quality of life is crucial. Surgery most significantly impacts on tumor natural history, postponing recurrence, improving symptoms, decreasing the need of adjuvant therapies, with extent of resection, gross-total and supra-total (GTR and STR), strongly associating with longest PFS. Achievement of GTR or STR depends on the degree of functional reorganization induced by glioma. Consequently, a successful treatment fostering neural circuit reorganization before surgery, would increase the chance of GRT\u002FSTR.\n\nHypothesis The plastic potential of motor system suggests that reorganization of circuits controlling hand movements could be presurgically fostered in LGG patients by enhancing plasticity with up-front motor-rehabilitation and\u002For by decreasing tumor infiltration with up-front chemotherapy. Advanced neuroimaging allows to infer the neuroplasticity potential. Intraoperative assessment of the motor circuits functionality will validate reliability of preoperative analyses.\n\nAims The project has 4 aims, investigating: A) the presurgical functional (FC) and structural (SC) connectomics of the hand-motor network to picture the spontaneous reorganization and the influence of clinical, imaging and histomolecular variables; B) the dynamic of FC and SC after tumor resection; C) changes in FC and SC maps after personalized upfront motor rehabilitation and\u002For chemotherapy; D) the effect of FC and SC upfront treatment on the achievement of GTR\u002FSTR preserving hand dexterity.\n\nExperimental Design Resting-state fMRI and diffusion-MRI will provide FC and SC maps pre- and post-surgery; personalized up-front motor rehabilitation and\u002For chemotherapy will be administered; Intraoperative brain mapping procedures will generate data to validate the maps.\n\nExpected Results\n\n1. Provide a tool to render the motor functional reorganization predictive of surgical outcome.\n2. Identify demographic, clinical and imaging variables associated with functional reorganization.\n3. Describe the gain induced by up-front treatment.\n4. Distinguish \"patterns\" predicting chance for GTR\u002FSTR from \"patterns\" suggesting need for up-front treatment.\n\nImpact On Cancer Results will increase the achievement of GTR\u002FSTR, preserving motor integrity, with dramatic impact on LGGs natural history.",[94,95],"Glioma","Glioma, Malignant",[94,97,98,99,100,101,102,103,104,105,106,107,108,109],"Neurosurgery","Chemotherapy, Neoadjuvant","Motor Rehabilitation","Magnetic Resonance Imaging","Diffusion Magnetic Resonance Imaging","Resting State Functional Magnetic Resonance Imaging","Functional Magnetic Resonance Imaging","Functional Connectomics","Structural Connectomics","Neuronal Plasticity","Higher Nervous Activity","Neurological Rehabilitation","Antineoplastic Protocols","2024-04-18",{"date":112,"type":113},"2024-04-24","ACTUAL",{"date":115,"type":113},"2024-03-07",{"date":117,"type":88},"2028-02-28",{"name":5,"class":6},1]