Spasticity in Stroke – Randomized Study A 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 60 人开始时间: 2010年10月19日最近更新: 2019年6月30日

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•To be eligible for inclusion into this study, patients must fulfil all of the following criteria prior to study enrolment:
•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. Patieint experienced last stroke > 6 months prior to enrolment
•4. Patient presents spasticity in at least two extremities
•5. Patient presents an Ashworth score of at least 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 the last month
•NOTE: ventriculo-peritoneal shunts and valves can be present
•8. If female, she must either:
•a. be post-menopausal or surgically sterilised; 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 the 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 58
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•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 anatagonists e.g. 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 injectin less than 4 months ago
•9. According to the investigator's opinion, the patient is not capable to comprehend the nature of the study and to give his/her informed consent him/herself

发起方

Medtronic International Trading