SISTERS: Spasticity In Stroke Study - Randomized Study
Condition: Severe Spasticity
MeSH terms: Muscle Spasticity
Intervention: intrathecal baclofen
Intervention description: ITB test, implant, 6 months follow-up
Intervention MeSH terms: Baclofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Severe spasticity in post-stroke patients

Summary:

      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.
    

Eligibility criteria:

        Inclusion criteria:

        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. patient experienced last stroke > 6 months prior to enrollment

          3. patient presents spasticity in at least 2 extremities

          4. patient presents an Ashworth score ≥ 3 in a minimum of two of the affected muscle
             groups in the lower extremities

          5. 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

          6. stable blood pressure: no change in hypertensive medication in last month (NOTE:
             ventriculoperitoneal shunts and valves can be present)

          7. 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

          8. patient/family is willing to comply with study protocol including attending the study
             visits

        Exclusion criteria:

        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 patient can
             switch to another accepted anticoagulant (e.g. heparin, aggrenox, fragmin, plavix,
             ticlid) for the period of ITB test and implant

          7. patient is pregnant or breastfeeding

          8. patient received a Botulinum toxin injection less than 4 months ago