SISTERS: Spasticity In Stroke Study - Randomized Study

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medtronic International Trading Sarl; MedtronicNeuro
• Treatments: Baclofen

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