Intrathecal (IT) Baclofen Drug Distribution

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University
• Collaborator: Medtronic
• Treatments: Baclofen

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