SISTERS: Spasticity In Stroke Study - Randomized Study

Completed · Phase 4

Conditions studied: Severe Spasticity

In brief

To demonstrate that Intrathecal Baclofen (ITB) Therapy, compared to Best Medical Treatment (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke patients with generalized spastic hypertonia who have not reached their therapy goal with other treatment interventions assessed by a decrease in the average Ashworth Scale (AS) score in the lower extremities.

Key facts

Study ID

NCT01032239

Run by

MedtronicNeuro

People needed

61

Starts

2009-11-01

Expected to finish

2016-09-01

Last updated by the study team

2018-02-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To be eligible for inclusion into this study, patients must fulfill all of the following criteria prior to study enrollment:
• patient (or legal guardian) has been informed of the study procedures and has given written informed consent
• patient experienced last stroke > 6 months prior to enrollment
• patient presents spasticity in at least 2 extremities
• patient presents an Ashworth score ≥ 3 in a minimum of two of the affected muscle groups in the lower extremities
• 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
• stable blood pressure: no change in hypertensive medication in last month (NOTE: ventriculoperitoneal shunts and valves can be present)
• if female, she must either be post-menopausal or surgically sterilized; or use a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study
• patient/family is willing to comply with study protocol including attending the study visits

You may not qualify if…

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

Where it is running

• University of California Irvine — Irvine, California, United States
• MedStar National Rehabilitation Network — Washington D.C., District of Columbia, United States
• Design Neuroscience Center — Doral, Florida, United States
• Rehabilitation Medical Group - Florida Hospital — Orlando, Florida, United States
• Tallahassee Neurological Clinic Department of Neurosurgery — Tallahassee, Florida, United States
• Saint Alphonsus Regional Med Center — Boise, Idaho, United States
• Research Medical Center — Kansas City, Missouri, United States
• Einstein Hospital/Moss Rehabilitation — Elkins Park, Pennsylvania, United States
• TIRR Memorial Herman Hospital — Houston, Texas, United States
• Sozialmedizinisches Zentrum Baumgartner Höhe Otto-Wagner-Spital — Vienna, Austria
• Landeskrankenhaus Hochzirl — Zirl, Austria
• Clin. Univ. UCL Saint Luc — Brussels, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• Universitaire Ziekenhuizen Leuven, campus Pellenberg — Leuven, Belgium
• Kliniken Beelitz GmbH Neurologische Rehabilitationsklinik — Beelitz-Heilstätten, Germany
• Ambulantes Neurologisches Rehabilitationszentrum — Bonn, Germany
• Therapiezentrum Burgau — Burgau, Germany
• Rhein-Sieg-Klinik Dr. Becker Klinikgesellschaft — Nümbrecht, Germany
• Centro di Riabilitazione "Villa Beretta" — Costa Masnaga, Italy
• Fondazione Salvatore Maugeri Clinica del lavoro e della riabilitazione IRCSS — Pavia, Italy
• Afdeling Revalidatie Academisch Ziekenhuis Maastricht — Maastricht, Netherlands
• Univerzitetni rehabilitacijski inštitut Republike Slovenije Soča — Ljubljana, Slovenia
• Fundació Privada Institut de Neurorehabilitació Guttmann, Badalona — Barcelona, Spain
• Hospital Universitario La Paz — Madrid, Spain
• St George's Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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