[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624682":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":45,"collaborators":49,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":20,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":78,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Individuals with functionally complete\u002Fincomplete non-traumatic spinal cord injury","EXPERIMENTAL","Individuals with functionally complete\u002Fincomplete non-traumatic spinal cord injury who will undergo SCS for chronic pain",[13],"Procedure: Spinal cord stimulation surgery (device implant) and motor rehabilitation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Spinal cord stimulation surgery (device implant) and motor rehabilitation","The first part of the study will involve a preoperative evaluation. Participants' clinical history, neurological, neurophysiological and advanced brain\u002Fspine MRI examination will be assessed (Part 1). Subsequently, participants will undergo spinal cord stimulation surgery which involves the implantation of a medical device (Part 2). After the surgery, the research participants will be hospitalized at the Neurosurgery Unit (5-14 days) to monitor the incision site (Part 3). Thereafter, the patients will be moved (for at least 6 weeks) to the Rehabilitation Unit in order to identify appropriate stimulation parameters for inducing stepping and standing and for starting training. The combination of epidural stimulation with manual step\u002Fstand training will be thus evaluated (Part 4). Patients will be finally assessed by clinical evaluation, advanced MRI and neurophysiological examination to study the brain, spine and peripheral functions after six months (Part 5).",[9],null,[22],{"facility":23,"status":20,"city":24,"state":20,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"IRCCS Ospedale San Raffaele","Milan","20132","Italy","IT",{"type":29,"coordinates":30},"Point",[31,32],9.18951,45.46427,{"lat":32,"lon":31},[35,41,44],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Luigi Albano, MD, PhD","CONTACT","0226435568","+39","albano.luigi@hsr.it",{"name":42,"role":43,"phone":20,"phoneExt":20,"email":20},"Pietro Mortini, MD","PRINCIPAL_INVESTIGATOR",{"name":36,"role":43,"phone":20,"phoneExt":20,"email":20},{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Albano Luigi","MD, PhD",[50],{"name":51,"class":6},"Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna","100624682","spinal-cord-stimulation-combined-with-motor-training-in-non-traumatic-sci-a-prospective-interventional-study-100624682",false,"NCT07412808","Spinal Cord Stimulation Combined With Motor Training in Non-Traumatic SCI: A Prospective Interventional Study","Evaluation of Spinal Cord Stimulation Assisted by Motor Rehabilitation Training for Restoring Motor Function in Non-traumatic Spinal Cord Injury: an Interventional, Prospective, Monocentric Study","Neuro-scs-002","Inclusion Criteria:\n\n1. Diagnosis of NTSCI at least one year before presentation;\n2. Complete or incomplete spinal cord damage (ASIA grade A, B or C) conditioning chronic neuropathic pain and motor impairment;\n3. Age ≥ 18 years;\n4. Indication to spinal cord stimulation surgery for chronic pain;\n5. Being unable to stand or step independently;\n6. No current anti-spasticity medication regimen;\n7. No botox injections in the prior 3 months;\n8. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;\n9. Willingness and ability to comply with scheduled visits and other trial procedures.\n\nExclusion Criteria:\n\n1. Any person unable to lie still within the environment of the MRI scanner for the required period to perform the study and those where MRI scanning is contraindicated;\n2. Pregnancy or breastfeeding;\n3. Any significant psychiatric disease;\n4. Use of illicit drugs;\n5. Unstable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate standing or stepping;\n6. Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training;\n7. Spinal cord involvement above the D1 segment;\n8. Severe peripheral neuropathies or damage to the cauda equine.","ALL","18 Years",{"count":63,"type":64},10,"ESTIMATED","INTERVENTIONAL",[67],"NA","Interventional prospective longitudinal on the evaluation of spinal cord stimulation (SCS) assisted by motor rehabilitation training for restoring motor function in patients with non-traumatic spinal cord injury (SCI). The investigators will enroll ten research participants with clinically incomplete\u002Fcomplete SCI (patients with paraplegia or severe paraparesis) who will undergo SCS subsequently assisted by motor rehabilitation training for restoring motor function at IRCCS Ospedale San Raffaele, Milan, Italy. The main goal of the project is to evaluate the improvement in motor function generated by the combination of SCS and locomotor training. In line with recently published studies, the investigators propose that daily locomotor training in the presence of SCS with continuous stimulation parameters setting will enable the SCI individuals to stand and step independently while bearing full weight.",[70,71],"Spinal Cord Disease","Spinal Cord Injuries (Complete and Incomplete)",[73,74,75,76,77],"motor restoration","rehabilitation","chronic pain","neuromodulation","spasticity","NOT_YET_RECRUITING","2026-02-09",{"date":81,"type":82},"2026-02-17","ACTUAL",{"date":84,"type":64},"2026-03",{"date":86,"type":64},"2029-04",{"name":47,"class":6},1]