[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559483":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":46,"responsibleParty":59,"collaborators":25,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":25,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":25,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":85,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early Baclofen treatment group","EXPERIMENTAL","Oral baclofen will be started as soon as any sign of acute spasticity consisting of spasms, velocity-dependent hypertonia and\u002For clonus is observed. Oral baclofen will be initiated the same day as when signs of spasticity are first observed.\n\nDosage : oral administration of baclofen is started initially at 5 mg three times a day. The dose is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response,",[13],"Drug: Early baclofen Intervention",{"label":15,"type":6,"description":16,"interventionNames":17},"Control group","The control group will receive the \"usual routine care\" as per which baclofen is prescribed only when acute spasticity becomes severe and problematic.\n\nIn the presence of problematic spasticity, oral administration of baclofen is started initially at 5 mg three times a day. The dose is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response.",[18],"Drug: Usual routine care",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Early baclofen Intervention","Baclofen is initiated as soon as any sign of acute spasticity.\n\n5 mg three times a day and is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response, i.e. when spasticity is no longer problematic.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Usual routine care","Baclofen is initiated only when acute spasticity is deemed problematic.\n\n5 mg three times a day and is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response.",[15],[31],{"name":32,"affiliation":33,"role":34},"Andréane Richard-Denis, M.D., MSC","CIUSSS du Nord-de-l'île-de-Montréal-Hôpital du Sacré-Cœur de Montréal","PRINCIPAL_INVESTIGATOR",[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Lara Chawa","CONTACT","514-338-2222","5833276","lara.chawa.cnmtl@ssss.gouv.qc.ca",{"name":43,"role":38,"phone":39,"phoneExt":44,"email":45},"Pascal Mputu","5833270","pascal.mputu.cnmtl@ssss.gouv.qc.ca",[47],{"facility":33,"status":25,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":25},"Montreal","Quebec","H4J 1C5","Canada","CA",{"type":54,"coordinates":55},"Point",[56,57],-73.58781,45.50884,{"lat":57,"lon":56},{"type":34,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Andréane Richard-Denis","Principal investigator","100559483","phase-4-early-pharmacological-treatment-of-acute-spasticity-after-spinal-cord-injury-100559483",false,"NCT06564714","Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury","Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury to Promote Long-term Neurofunctional Recovery: a Randomized Clinical Trial","Inclusion Criteria:\n\n* Male or female aged 18 years or older\n* Blunt (non-penetrating) traumatic SCI\n* AIS grade A to D\n* NLI between C0 and L1\n* Patient willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Non-traumatic SCI (e.g. tumor, infection, transverse myelitis, etc.)\n* AIS grade E upon admission\n* Penetrating tSCI (from stab wound, gunshot injury, etc.)\n* Cauda equina syndrome or NLI below L1\n* Moderate or severe brain injury (mild traumatic brain injury not an exclusion criteria)\n* Contraindication to oral baclofen use (needs clearance from attending physician and pharmacological consultant)\n* Pre-existing neurological disorders (cerebrovascular disease, Parkinson's disease, multiple sclerosis, etc.)\n* Major cognitive deficits precluding informed consent and\u002For assessments\n* Unlikely to comply with scheduled visits (e.g. living in another country)\n* Renal insufficiency","ALL","18 Years",{"count":72,"type":73},55,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","The objective of this clinical trial is to evaluate if early detection of spasticity and immediate treatment with oral baclofen during acute care prevents problematic spasticity and improves neurofunctional recovery after tSCI.\n\nThe main questions it aims to answer are :\n\n1. Assess the safety of early baclofen treatment during acute care after SCI.\n2. Compare the neurofunctional outcomes between the early baclofen group and the control group up to 6 months after tSCI, in terms of mobility, global functional independence, neurological recovery, pain and spasticity.\n\nThe early baclofen group will receive oral administration of baclofen as soon as any sign of acute spasticity is observed. The dose is started initially at 5 mg three times a day and is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response, i.e. when spasticity is no longer problematic. The control group however will receive the \"usual routine care\" at our institution as per which baclofen is initiated by the attending physician (i.e. physiatrist or spine surgeon) only when acute spasticity becomes severe and problematic.",[79],"Traumatic Spinal Cord Injury",[81,82,83,84],"Trauma","Spinal Cord Injury","Baclofen","Spasticity","NOT_YET_RECRUITING","2024-08-19",{"date":88,"type":89},"2024-08-21","ACTUAL",{"date":91,"type":73},"2024-12",{"date":93,"type":73},"2029-06",{"name":5,"class":6},1]