spasticity spierspasmen
Conditions
Interventions
There are several interventions as compared to the normal ITB-test-infusion
protocol.
Baclofen test-infusion
•Patients will receive an additional intrathecal catheter, the same catheter
that is use
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Patients will have to meet the requirements necessary for implantation of an ITB pump. -Patients can be monitored regularly (at least once / 6 weeks) during the year after pump implantation. -Patients details can be taken, including the following details: o Gender, date of birth, o Length, weight, blood pressure o Medication o Underlying disease, year of onset o Daily oral baclofen dose and duration of oral baclofen treatment -Female patients at fertile age need to guarantee adequate anti-conception.
Exclusion criteria
Exclusion criteria: -Patients who have a contra-indication for intrathecal catheter placement: o Anti-clotting medication o Low platelet count o Elevated intracranial pressure o The presence of another electronic device -Patients who don*t reach a satisfactory effect in the test-infusion phase. -Patients experiencing pump failures during the duration of the study -Patients below the age of 18 -Pregnancy or female patients at fertile age who cannot guarantee adequate anti-conception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of tolerance in patients receiving intrathecal baclofen therapy, determined by baclofen dose and spasticity (MAS) from pump implantation to 1 year after pump implantation | — |
Secondary
| Measure | Time frame |
|---|---|
| -CSF baclofen concentration of patients and the creation of a PK/PD-model for ITB -Individual patient characteristics as are described in the protocol. | — |
Countries
Netherlands
Outcome results
None listed