[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tetraplegics\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tetraplegics":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100563774","restoring-hand-function-in-patients-with-tetraplegia-by-intraneural-stimulation-of-peripheral-nerves-100563774",false,"NCT06620536","Restoring Hand Function in Patients with Tetraplegia by Intraneural Stimulation of Peripheral Nerves","REGRASP","Inclusion Criteria:\n\n1. Men or women aged between 18 and 70.\n2. Spinal cord injury at the C5-6 level, with complete motor paralysis (ASIA A or ASIA B).\n3. Chronic injury (\\> 6 months), with stable clinical condition.\n\nExclusion Criteria:\n\n1. Systemic infections.\n2. Central and\u002For peripheral nervous system comorbidity.\n3. Reduced joint flexibility.\n4. Severe spasticity of the upper limb (mAS 3).\n5. Severe denervation of forearm and hand muscles (as demonstrated by electromyography and electroneurography analysis and intraoperative neural stimulation).\n6. Muscles not electrically excitable.\n7. Presence of hyperalgesia or allodynia.\n8. Wearers of life support devices that could be adversely affected by electromagnetic interference, such as pacemakers, implanted cardioverter defibrillators, etc.\n9. Cognitive impairment.\n10. Active or history of psychiatric illnesses including major depression, bipolar disorder and personality disorders (borderline or antisocial personality disorder).\n11. Pregnancy.\n12. History of alcohol or substance abuse.\n13. Acquired brain injury with residual deficits.\n14. Participation in other clinical trials.\n15. Known allergies\u002Fhypersensitivity to TIME-4H electrode materials.\n16. Life expectancy of less than one year.\n17. Contraindications to general anaesthesia (patient refusal, severe aortic stenosis, significant pulmonary disease, etc.).","ALL","18 Years","70 Years",{"count":20,"type":21},2,"ESTIMATED","INTERVENTIONAL",[24],"NA","The aim of the clinical investigation is to evaluate the feasibility, in terms of efficacy and safety, of a prosthetic system, the Regrasp 1 system, based on intraneural stimulation via TIME- 4H electrodes, as an aid device for restoring hand function in tetraplegic patients.",[27],"Tetraplegics",[29,30,31,32],"electrodes","intraneural stimulation","hand","tetraplegia","NOT_YET_RECRUITING","2024-09-27",{"date":36,"type":37},"2024-10-01","ACTUAL",{"date":39,"type":21},"2024-10",{"date":41,"type":21},"2026-12",{"name":43,"class":44},"Azienda Ospedaliero-Universitaria Careggi","OTHER"]