[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581009":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":29,"responsibleParty":47,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":64,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Shanghai 6th People's Hospital","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Intrathecal baclofen management of hereditary spastic paraparesis",null,"Patients with hereditary spastic paraparesis aged 14 to 70 years, with a Modified Ashworth Scale score of greater or equal to 3 in 2 or more joints of lower limb, and agree to undergo Intrathecal baclofen surgery will be recruited. Patients will receive professional assessment every six months.",{"label":13,"type":10,"description":14,"interventionNames":10},"The oral baclofen group","Patients who do not agree to intrathecal baclofen treatment or those who do not achieve satisfactory therapeutic effect during the baclofen testing phase will be included in oral baclofen group. Patients will receive professional assessment every six months, with natural history observation.",[16],{"name":17,"affiliation":18,"role":19},"Li Cao, phD","Shanghai Jiao Tong University Affiliated Sixth People's Hospital","PRINCIPAL_INVESTIGATOR",[21,25],{"name":17,"role":22,"phone":23,"phoneExt":10,"email":24},"CONTACT","+86 21 64369263","caoli2000@yeah.net",{"name":26,"role":22,"phone":27,"phoneExt":10,"email":28},"Wotu Tian, phD","+86 21 64369181","wotu_tian@163.com",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine","RECRUITING","Shanghai","Shanghai Municipality","213000","China","CN",{"type":39,"coordinates":40},"Point",[41,42],121.45806,31.22222,{"lat":42,"lon":41},[45],{"name":26,"role":22,"phone":46,"phoneExt":10,"email":28},"21 64369181",{"type":19,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Li Cao","Professor","100581009","a-prospective-cohort-study-of-itb-treatment-for-hsp-100581009",false,"NCT06844734","A Prospective Cohort Study of ITB Treatment for HSP","Intrathecal Baclofen for the Management of Hereditary Spastic Paraparesis: a Prospective Cohort Study","ITB-HSP","Inclusion Criteria:\n\n* Patients meet the clinical and genetic diagnostic criteria of hereditary spastic paraplegia (HSP);\n* Age: 14 to 70 years old\n* Modified Ashworth Score for lower limbs: ≥2 joints with muscle tone ≥grade 3\n* Patients are willing to participate in clinical trials and able to understand and comply with the research program\n\nExclusion Criteria:\n\n* Patients are allergic to the baclofen\n* Other neurological diseases likely affecting the evaluation of study treatment\n* Other medical conditions such as: heart disease, tumor, blood disease, liver disease, kidney disease, etc. in the past 1 year\n* Pregnancy or lactating women or subjects who are unable to use appropriate contraception during the trial\n* Participating in another study drug trial and used the investigational drug in the past 30 days\n* Subjects have poor compliance or other factors that are not suitable for participating in the clinical trial","ALL","14 Years","70 Years",{"count":62,"type":63},50,"ESTIMATED","3 Years","OBSERVATIONAL","The investigators conduct a prospective cohort study to explore the treatment effectiveness of continuous infusion of intrathecal baclofen (ITB) for hereditary spastic paraplegia (HSP) in China, delve into the optimal timing for starting treatment, and investigate the response differences among different subtypes. The ultimate goal is to provide clinical evidence and guidance for the application of ITB in treating HSP in China, as well as improve the life expectancy and quality of life for HSP patients. The main questions it aims to answer are:\n\n1. Changes in gait and motor function, as well as spasticity levels, compared to pre-surgery and control group after ITB surgery.\n2. Changes in quality of life, pain, psychological and emotional status, and cognition compared to pre-surgery and control group after ITB surgery.\n3. Complications following ITB surgery.\n4. Impact of ITB surgery on the occurrence and progression of skeletal deformities.\n5. Subgroup analysis: comparing surgical outcomes between different genotypes and between simple versus complex types.\n6. Determine the optimal timing for ITB intervention.",[68],"Hereditary Spastic Paraplegia",[70,71],"Hereditary Spastic Paraparesis","Intrathecal baclofen","2025-02-24",{"date":74,"type":75},"2025-02-26","ACTUAL",{"date":77,"type":75},"2025-01-01",{"date":79,"type":63},"2028-03-01",{"name":5,"class":6},1]