Spasticity in Stroke – Randomized StudyA randomized, controlled, open-label, parallel-group, multi-center study to compare the effect of Intrathecal Baclofen Therapy (ITB Therapy®) versus Best Medical Treatment (BMT) on spasticity in post-stroke patients after 6 months active treatment - SISTERS

Medtronic International trading0 个研究点目标入组 88 人开始时间: 2009年11月11日最近更新: 2017年1月9日

适应症

试验速览

暂无简介。

•To be eligible for inclusion into this study, patients must fulfill all of the following criteria prior to study enrollment:
•1.patient (or legal guardian) has been informed of the study procedures and has given written informed consent
•2.18-75 years of age
•3.patient experienced last stroke > 6 months prior to enrollment
•4.patient presents spasticity in at least 2 extremities
•5.patient presents an Ashworth score = 3 in a minimum of two of the affected muscle groups in the lower extremities
•6.patient is eligible to receive ITB Therapy following the Adult Spasticity Algorithm
•a.Patient does not reach his/her therapy goal with other treatment interventions
•7.patient is medically stable:
•a.stable blood pressure:
•i.no change in hypertensive medication in last month
•NOTE: ventriculo-peritoneal shunts and valves can be present
•8.If female, she must either
•a.be post-menopausal or surgically sterilized; or
•b.use a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study
•9.patient/family is willing to comply with study protocol including attending the study visits
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•To be eligible for inclusion in this study the patients must not meet any of the following criteria:
•1.patient/family is considered by the physician to be unable or unwilling to participate in long-term ITB Therapy management
•2.patient has known hypersensitivity to baclofen
•3.active systemic infection
•NOTE: pressure sores are not a contraindication unless they are present near the implant sites
•4.presence of a cardiac pacemaker, ICD, implantable neurostimulator or drug delivery device
•5.uncontrolled refractory epilepsy
•6.use of oral vitamin K antagonists, eg warfarin or coumadin; unless the patient can switch to another accepted anticoagulant (e.g. heparin) for the period of ITB test and implant
•7.patient is pregnant or breast-feeding
•8.patient received a Botulinum toxin injection less than 4 months ago

发起方

Medtronic International trading