Intrathecal (IT) Baclofen Drug Distribution

NCT02903823 | Completed Phase 4 Results

• 1 other identifier: 151399
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Spasticity

Keywords

spinal cord injury; cerebral palsy; stroke

Outcome Measures

Primary Outcomes (2)

• Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Cerebral Origin

  The Modified Ashworth Scale (MAS) is a 6-point scale (Standard MAS scale values: "0, 1, 1.5, 2, 3, or 4") used to evaluate spasticity based on grading muscle tone by moving joints. The MAS scores in this cohort are measured in biceps, triceps and forearm flexor muscles in upper extremities; and quadriceps, hamstrings and gastrocnemius muscles in lower extremities. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Improvement in spasticity was a reduction in MAS score by 1 point across a joint tested. Maximal MAS change is the sum of MAS score reduction in all four limbs tested. This outcome looks at subjects with spasticity of cerebral origin.

  Baseline to 6 hours post-injection

• Subjects Experiencing Maximal MAS Change From Baseline - Spasticity of Spinal Origin

  The Modified Ashworth Scale (MAS) is a 6-point scale (Standard MAS scale values: "0, 1, 1.5, 2, 3, or 4") used to evaluate spasticity based on grading muscle tone by moving joints. The MAS scores in this cohort are measured in biceps, triceps and forearm flexor muscles in upper extremities; and quadriceps, hamstrings and gastrocnemius muscles in lower extremities. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Improvement in spasticity was a reduction in MAS score by 1 point across a joint tested. Maximal MAS change is the sum of MAS score reduction in all four limbs tested. This outcome looks at subjects with spasticity of spinal origin.

  Baseline to 6 hours post-injection

Study Arms (1)

Baclofen injection at designated spinal level

EXPERIMENTAL

Days 2,3,4,5 a baclofen injection bolus will be given in the catheter, located at C4, T4, T10 and L2 respectively. Effect of baclofen injection (50 microgram bolus) upon rigidity will be assessed manually using the Modified Ashworth rating score for selected upper and lower extremities.

Drug: Baclofen bolus injection

Interventions

Baclofen bolus injection DRUG

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.

Also known as: Injection of baclofen bolus

Baclofen injection at designated spinal level

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients with spasticity from spinal origin (spinal cord injury)
• Adult patients with spasticity of cerebral origin (cerebral palsy and cerebrovascular accident)
• Adult women of child bearing age with a negative pregnancy test

You may not qualify if:

• Patients with spasticity from Multiple sclerosis
• Pregnant women
• Patients under the age of 18 years
• Patients over the age of 50
• Patients who are unable to have an MRI scan of the total spine
• Patients with spinal deformity that would prevent easy access to the lumbar intrathecal space
• Patients who have an allergic reaction to IT baclofen
• Patients who have significant headache from CSF withdrawal
• Patients who have intradural blockage that prevents advancing the IT catheter to the level of C4

Sponsors & Collaborators

• Vanderbilt University: lead
• Medtronic: collaborator

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (6)

• 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.

  PMID: 8613874 BACKGROUND

• 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.

  PMID: 7690122 BACKGROUND

• 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.

  PMID: 10515478 BACKGROUND

• Albright AL. Technique for insertion of intraventricular baclofen catheters. J Neurosurg Pediatr. 2011 Oct;8(4):394-5. doi: 10.3171/2011.7.PEDS11211.

  PMID: 21961547 BACKGROUND

• 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.

  PMID: 8421205 BACKGROUND

• 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.

  PMID: 16619633 BACKGROUND

MeSH Terms

Conditions

Muscle Spasticity; Spinal Cord Injuries; Cerebral Palsy; Stroke

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Brain Damage, Chronic; Brain Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Small number of subjects. Non-randomized trial. Inter-rater variability of assessments.

Results Point of Contact

• Title: Peter Konrad, MD PhD - PI
• Organization: Vanderbilt University Medical Center

peter.konrad@vumc.org

6153439822

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 16, 2016
• Study Start: April 22, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 22, 2022
• Results First Posted: April 27, 2021

Record last verified: 2022-02

Locations

US (1)