Intrathecal (IT) Baclofen Drug Distribution

While ITB therapy is commonly recommended for treatment of severe spasticity due to a variety
of diseases, the location of optimal drug (baclofen) delivery has not been defined in a
controlled study. Furthermore, the cost of pharmacological management in these patients is
significant, and optimal location for drug delivery through an implantable drug pump may have
significant impact on the cost burden of maintenance refills. It is the goal of this pilot
study to determine whether there is a significant therapeutic advantage to place the ITB
catheter within the cervical, thoracic or lumbar region of the spine. It is also a goal of
this pilot study to determine whether the origin of spasticity influences the effect of
Lioresal Intrathecal (baclofen injection) on ITB catheters located in the cervical, thoracic
or lumbar regions of the spine. The investigators propose to study the impact of catheter
location on the reduction in spasticity within a group of patients who are scheduled for ITB
trial. In studying the impact of catheter location among patients with spinal versus cerebral
origin of spasticity, the disease origin may also have a significant impact on baclofen
dosing relative to the placement of the catheter.

In addition, the pharmacokinetic half-life and the variability of intrathecal baclofen is
poorly understood as data is limited. In order to provide initial data regarding CSF baclofen
washout, samples of spinal fluid obtained just prior to- and following IT baclofen
administration will be obtained for delayed analysis. The results of these pharmacological
analysis may refine the understanding of how quickly baclofen is distributed from a given
catheter location, and whether it is affected by catheter location or disease origin. Since
multiple catheter locations will be studied within a given patient, it also affords the
opportunity to sample small amounts of CSF at key anatomical sites along the spinal axis as a
secondary objective.

Inclusion Criteria:

1. Adult patients with spasticity from spinal origin (spinal cord injury)

2. Adult patients with spasticity of cerebral origin (cerebral palsy and cerebrovascular
accident)

3. Adult women of child bearing age with a negative pregnancy test

Exclusion Criteria:

1. Patients with spasticity from Multiple sclerosis

2. Pregnant women

3. Patients under the age of 18 years

4. Patients over the age of 50

5. Patients who are unable to have an MRI scan of the total spine

6. Patients with spinal deformity that would prevent easy access to the lumbar
intrathecal space

7. Patients who have an allergic reaction to IT baclofen

8. Patients who have significant headache from CSF withdrawal

9. Patients who have intradural blockage that prevents advancing the IT catheter to the
level of C4