Intrathecal Baclofen and Pediatric Dystonia
A legfontosabb adatok
- Hol
- Houston (Egyesült Államok)A helyszín megnézése
Helyszínek itt: Egyesült Államok
- Texas Childrens HospitalHouston, Egyesült ÁllamokContact: Principal Investigator, MD, PhDRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Baylor College of Medicine
- Azonosító
- NCT06606574
- A regiszteradat frissítve
- 2026. november 5.
- Eredeti leírás
The goal of this study is to better understand outcomes in children with dystonic cerebral palsy (CP) receiving intrathecal baclofen (ITB), ventral dorsal rhizotomy (VDR), or deep brain stimulation (DBS) as part of standard clinical care. The decision to proceed with ITB, VDR, or DBS is made independently of research participation.A teljes eredeti leírásKevesebb
Predicting Response In Children With Dystonic Cerebral Palsy to Intrathecal Baclofen (Predict-ITB), Ventral Dorsal Rhizotomy (Predict-VDR), and Deep Brain Stimulation (Predict-DBS)
The goal of this study is to better understand outcomes in children with dystonic cerebral palsy (CP) receiving intrathecal baclofen (ITB), ventral dorsal rhizotomy (VDR), or deep brain stimulation (DBS) as part of standard clinical care. The decision to proceed with ITB, VDR, or DBS is made independently of research participation.
The study aims to:
1. Evaluate changes in dystonia and other clinically important outcomes; 2. Identify characteristics associated with treatment response; and 3. Develop a multidimensional outcome measure for children with dystonic CP.
Participants receiving ITB will follow a study-specific standardized titration protocol designed to identify a dose that provides maximum benefit with minimal side effects. Participants in all three groups will complete research assessments and questionnaires at protocol-specified timepoints to evaluate dystonia, spasticity, function, pain, stress, and quality of life.
Bevonási feltételek: Child must be large enough to have an ITB pump implanted (typically ~18 kg/4 years old); Child must be less than 21 years of age; They have a diagnosis of CP; Presence of dystonia verified with a documented Hypertonia Assessment Tool (HAT) and they must have a Barry-Albright Dystonia Scale (BADS) score >14; They have been identified by a physician for ITB treatment for tone management and the family/child have agreed to proceed with implantation; note: an ITB trial dose is not necessary to qualify; Child and family are willing to participate in full schedule of formal assessments, spanning pre-implantation, every 2 weeks until ideal intrathecal baclofen pump dosing is reached, and follow-up assessments; Child must be less than 21 years of age; They have a diagnosis of CP; Presence of dystonia verified with a documented Hypertonia Assessment Tool (HAT) and they must have a Barry-Albright Dystonia Scale (BADS) score >14; Currently less than 12 months post ITB pump implant for tone management; Child and family are willing to participate in the 12-month outcome measure assessment; Child must be less than 21 years of age; They have a diagnosis of CP; Presence of dystonia verified with a documented Hypertonia Assessment Tool (HAT); They have been identified by a physician as a candidate for VDR for tone management and the family/child have agreed to proceed with surgery; Child must be less than 21 years of age; They have a diagnosis of CP and have been identified by a physician as a candidate for DBS.
Kizáró feltételek: Emergent need for ITB such as status dystonicus or paroxysmal sympathetic hyperactivity; Botulinum injections within 3 months or phenol injections within 6 months; Foster care placement or incarceration; Family not willing to participate in schedule of assessments.