Intrathecal (IT) Baclofen Drug Distribution
Condition: Muscle Spasticity
MeSH terms: Muscle Spasticity
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Baclofen bolus injection
Intervention type(s): Drug
Intervention description(s): A baclofen bolus injection (50 micrograms) will be administered daily after the patient returns from radiology to position catheter injection location. The injection may be given at C4, T4, T10 or L2 spinal locations depending on the catheter tip location.
Other intervention name(s): Injection of baclofen bolus
Intervention MeSH terms: Baclofen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: spinal cord injury; cerebral palsy; stroke