[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655764":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":24,"studyPopulation":27,"armGroups":24,"interventions":24,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":65,"collaborators":24,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":24,"eligibilityCriteria":73,"healthyVolunteers":70,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":24,"studyType":80,"phases":24,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":40,"whyStopped":24,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":24},[9,13],{"measure":10,"description":11,"timeFrame":12},"Improved Spasticity Score","We will study changes in Spasticity using the Modified Ashworth Scale in participants over the course of this study.","From enrollment to 5 years",{"measure":14,"description":15,"timeFrame":16},"Improved Dystonia Score","We will use the Barry Albright Dystonia Scale to measure changes in dystonia in participants over the course of this study.","From enrollment to 5 years.",[18,21],{"measure":19,"description":20,"timeFrame":12},"Overall Quality of Life Improvements","We will use the CP-Child survey to measure quality of life changes in participants over the course of this study. Specifically looking at trends in caregiver satisfaction with hygiene, and comfort.",{"measure":22,"description":23,"timeFrame":16},"Reduced Surgical Complications","We will review outcomes for our participants to quantify surgical complications such as infection, malfunction, re-operation, spinal fluid leak, prolonged urinary retention, muscle wasting, and decubitus ulcer formation.",null,{"allocation":24,"interventionModel":24,"interventionModelDescription":24,"primaryPurpose":24,"observationalModel":6,"timePerspective":26,"maskingInfo":24},"PROSPECTIVE","Patients will be recruited from the Cerebral Palsy and multidisciplinary tone management clinic.",[29],{"name":30,"affiliation":5,"role":31},"Weston Northam, MD","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},"Adam Porter, Research Manager, MPH","CONTACT","617-919-6013","adam.porter@childrens.harvard.edu",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-71.05977,42.35843,{"lat":50,"lon":49},[53,55,56,59,61,63],{"name":54,"role":35,"phone":36,"phoneExt":24,"email":37},"Adam Porter, MPH",{"name":30,"role":31,"phone":24,"phoneExt":24,"email":24},{"name":57,"role":58,"phone":24,"phoneExt":24,"email":24},"Kristin Buxton, PNP","SUB_INVESTIGATOR",{"name":60,"role":58,"phone":24,"phoneExt":24,"email":24},"Juliani Mariani, MD",{"name":62,"role":58,"phone":24,"phoneExt":24,"email":24},"Scellig Stone, MD, PhD",{"name":64,"role":58,"phone":24,"phoneExt":24,"email":24},"Carley Vuillermin, MBBS, MPH, FRACS",{"type":31,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Weston Thomas Northam","Assistant Professor of Neurosurgery, Harvard Medical School","100655764","outcomes-of-neurosurgical-tone-management-100655764",false,"NCT07817745","Outcomes of Neurosurgical Tone Management","Inclusion Criteria:\n\n* Any patients undergoing intrathecal baclofen pump insertion or combined dorsal ventral rhizotomy at Boston Children's Hospital.\n* Must be at least 6 years of age at time of enrollment\n\nExclusion Criteria:\n\n\\-","ALL","6 Years","25 Years",{"count":78,"type":79},100,"ESTIMATED","OBSERVATIONAL","Patients with spastic\u002Fdystonic quadriplegia (GMFCS IV\u002FV) are often severely disabled by their tone, and require surgical tone management to improve quality of life, allow for better function, improve comfort, and range of motion. This has historically been limited to Intrathecal Baclofen (ITB) pumps, which are effective for up to 85% of patients but carry significant morbidity \u002F complications and are not appropriate for many patients. More recently, combined dorsal\u002Fventral rhizotomy (CR) has emerged as an alternative means for tone control, a one-time surgery with no required hardware implantation. However, more information is needed regarding long-term outcomes of this procedure in addition to comparative outcomes of ITB. This information will lead to improved patient selection, counseling, and care. This is a prospectively enrolled, single-center study, involving survey administration and clinical observation of outcomes pre- and post-surgery.",[83,84],"Spastic\u002FDystonic Quadriplegia","Cerebral Palsy (CP)",[86,87,88,89,90,91,92,93],"CP","Cerebral Palsy","Tone Management","Dystonic","Spastic","Spasticity","Intrathecal Baclofen Pump","Combined Dorsal\u002FVentral Rhizotomy","2026-09-08",{"date":96,"type":97},"2026-09-14","ACTUAL",{"date":99,"type":97},"2024-06-26",{"date":101,"type":79},"2031-01-01",{"name":5,"class":6},1]