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
Phase 4
Completed
- Conditions
- spasticitystroke10007963
- Registration Number
- NL-OMON39143
- Lead Sponsor
- Medtronic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
Inclusion Criteria
- 18-75 years old
- stroke not more than 6 months ago
- spasticity in 2 extremities
- Ashworth score > 2
- patient suitable acc. Adult Spasticity Algorithm (not enough effect with other treatments)
- stable blood pressure
- not pregnant
Exclusion Criteria
- acute systemic infection
- presence of pacemaker, ICD, neurostimulator, drug delivery system
- oncontrolled refractoire epilepsy
- use of vitamin K antagonists
- preganant or breast feeding
- Botuline toxine injection less than 4 months ago
- Patient not able to give his/her informed consent himself/herself
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>degree of reducing the spasticity in the lower extremities on the Ashworth<br /><br>Scale (AS) </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Side effects<br /><br>- Differences in efficacy between the 2 groups through tests and questionnaires</p><br>