A randomized, controlled, open-label, parallel-group, multicenter study to compare the effect of Intrathecal Baclofen Therapy (ITB Therapy) versus Best Medical Treatment (BMT) on severe spasticity in post-stroke patients after 6 months active treatment - SISTERS

Medtronic International Trading Sarl0 个研究点目标入组 88 人开始时间: 2009年9月10日最近更新: 2017年10月2日

试验速览

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•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 af-fected muscle groups in the lower extremities
•6. patient is eligible to receive ITB Therapy following the Adult Spasticity Al-gorithm
•a. patient does not reach his/her therapy goal with other treatment in-terventions
•7. stable blood pressure:
•a. 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, e.g. warfarin/coumadin; unless the pa-tient can switch to another accepted anticoagulant (e.g. heparin, aggre-nox, fragmin, plavix, ticlid) 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

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