[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636643":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":48,"collaborators":25,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":25,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":25,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":25,"overallStatus":72,"whyStopped":25,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"G. d'Annunzio University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CLBP Patients","EXPERIMENTAL","This arm includes 20 participants with a clinical diagnosis of non-specific chronic low back pain (duration \\> 3 months).\n\nParticipants undergo a clinical and functional evaluation through validated scales (VAS, RMDQ, MPQ, Waddell Index, Zung SAS\u002FSDS, BAQ).\n\nThe experimental procedure consists of a 3T MRI session including two resting-state fMRI blocks: one in a neutral condition and one while interacting with a \"perceptive surface\" (postural mat with sensory cones).\n\nAdvanced microstructural imaging (SANDI model) is also performed.",[13],"Device: Perceptive Surface (SU-PER mat)",{"label":15,"type":16,"description":17,"interventionNames":18},"Healthy Controls","ACTIVE_COMPARATOR","This arm includes 20 healthy volunteers, aged 18-45, without history of chronic pain.\n\nParticipants undergo the same 3T MRI protocol as the clinical group (neutral vs. perceptive surface conditions) to provide a baseline for \"normal\" cortical representation and connectivity.\n\nClinical evaluations for this group are limited to demographic data and the Visual Analogue Scale (VAS) for pain\u002Fdiscomfort monitoring during the scan.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Perceptive Surface (SU-PER mat)","The intervention consists of a postural mat equipped with sensory cones of varying elastic memory and elasticity.\n\nThis tool is used as a neurocognitive rehabilitation device designed to restore body perception and postural control.\n\nThe device is passive, non-magnetic, and made of MRI-compatible latex (inert material).\n\nDuring the fMRI session, the surface is positioned so that the participant, while lying in the scanner, perceives specific plantar or trunk tactile and proprioceptive stimuli.",[9,15],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Teresa Paolucci","CONTACT","+39 3278588219","teresa.paolucci@unich.it",[33],{"facility":34,"status":25,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"ITAB - Istituto di Tecnologie Avanzate Biomediche - Università degli Studi \"G. d'Annunzio\"","Chieti","Chieti (CH)","66100","Italy","IT",{"type":41,"coordinates":42},"Point",[43,44],14.16494,42.34827,{"lat":44,"lon":43},[47],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},{"type":49,"investigatorFullName":28,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Associate Professor","100636643","brain-connectivity-and-perceptive-surfaces-in-chronic-low-back-pain-super-rmnf-100636643",false,"NCT07568353","Brain Connectivity and Perceptive Surfaces in Chronic Low Back Pain (SUPER-RMNf)","Lombalgia Cronica Aspecifica e Superfici Percettive: Rappresentazione Corticale Del Tronco Nella Risposta al Trattamento Riabilitativo - Studio Quasi-sperimentale Non Randomizzato","Inclusion Criteria:\n\n* Aged between 18 and 45 years\n* Right-handed dominance\n* Good general health condition\n* Ability to provide written informed consent.\n\nFor the patient group:\n\n\\- Clinical diagnosis of non-specific chronic low back pain with a duration of more than 3 months\n\nFor the control group:\n\n\\- Healthy volunteers without a history of chronic pain\n\nExclusion Criteria:\n\n* Contraindications to 3T Magnetic Resonance Imaging, such as pacemakers or non-compatible metallic implants\n* Pregnancy or breastfeeding\n* Presence of significant neurological or psychiatric pathologies\n* Current use of psychoactive medications.\n* Sensory or motor disorders of the lower limbs that prevent interaction with the perceptive surface.\n* Unstable or acute clinical conditions.\n* Inability to remain still during the MRI scanning procedure",true,"ALL","18 Years","45 Years",{"count":63,"type":64},40,"ESTIMATED","INTERVENTIONAL",[67],"NA","Rationale:\n\nChronic Low Back Pain (CLBP) is often associated with \"cortical reorganization,\" where the brain's map of the back becomes less precise. This phenomenon contributes to the persistence of pain and reduced body awareness. While traditional rehabilitation focuses on the physical structure of the spine, neurocognitive approaches use \"perceptive surfaces\" to provide specific tactile and proprioceptive feedback, aiming to \"retrain\" the brain's representation of the trunk.\n\nObjective and Hypothesis:\n\nThe primary goal of this study is to investigate how the brain responds to stimulation from these perceptive surfaces in patients with CLBP compared to healthy individuals. The investigators hypothesize that using these surfaces will lead to immediate changes in functional brain connectivity, particularly in areas responsible for body awareness and pain processing (somatosensory and salience networks).\n\nStudy Procedures:\n\nThe study will involve 20 patients with chronic non-specific low back pain and 20 healthy volunteers. All participants will undergo a Functional Magnetic Resonance Imaging (fMRI) session. During the scan, participants will be placed on a specialized perceptive surface. Brain activity and connectivity will be measured at rest and during specific tactile stimulation. Additionally, advanced imaging techniques (SANDI model) will be used to look at the microscopic structure of brain cells (neurons).\n\nClinical Impact:\n\nBy comparing the two groups, the study aims to identify specific \"brain signatures\" of recovery. This could help clinical professionals understand if perceptive surfaces can effectively restore cortical maps, leading to better personalized rehabilitation strategies for chronic pain.",[70,71],"Low Back Pain","Healthy","NOT_YET_RECRUITING","2026-04-30",{"date":75,"type":76},"2026-05-05","ACTUAL",{"date":78,"type":64},"2026-05-01",{"date":80,"type":64},"2026-07-01",{"name":5,"class":6},1]