Clinical trial NCT02903823: Intrathecal (IT) Baclofen Drug Distribution
Official title: Intrathecal (IT) Baclofen Drug Distribution Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Muscle Spasticity
Keywords: spinal cord injury
cerebral palsy
stroke
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2016-09-16
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Cerebral Origin
timeFrame: Baseline to 6 hours post-injection
measure: Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Spinal Origin
timeFrame: Baseline to 6 hours post-injection
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
References:
citation: Penn RD. Catheter implant systems for intrathecal drug delivery. J Neurosurg. 1996 Apr;84(4):713. doi: 10.3171/jns.1996.84.4.0713a. No abstract available.
citation: Kroin JS, Ali A, York M, Penn RD. The distribution of medication along the spinal canal after chronic intrathecal administration. Neurosurgery. 1993 Aug;33(2):226-30; discussion 230.
citation: Grabb PA, Guin-Renfroe S, Meythaler JM. Midthoracic catheter tip placement for intrathecal baclofen administration in children with quadriparetic spasticity. Neurosurgery. 1999 Oct;45(4):833-6; discussion 836-7. doi: 10.1097/00006123-199910000-00020.
citation: Albright AL. Technique for insertion of intraventricular baclofen catheters. J Neurosurg Pediatr. 2011 Oct;8(4):394-5. doi: 10.3171/2011.7.PEDS11211.
citation: Coffey JR, Cahill D, Steers W, Park TS, Ordia J, Meythaler J, Herman R, Shetter AG, Levy R, Gill B, et al. Intrathecal baclofen for intractable spasticity of spinal origin: results of a long-term multicenter study. J Neurosurg. 1993 Feb;78(2):226-32. doi: 10.3171/jns.1993.78.2.0226.
citation: Albright AL, Turner M, Pattisapu JV. Best-practice surgical techniques for intrathecal baclofen therapy. J Neurosurg. 2006 Apr;104(4 Suppl):233-9. doi: 10.3171/ped.2006.104.4.233.