Intrathecal Baclofen Therapy for Severe Spasticity

There are many factors critical to the success of ITB TherapySM . One of the most important is careful patient selection.

Who Can Benefit?

Who Can Benefit from Intrathecal Baclofen Therapy?

ITB Therapy for the management of severe spasticity should be considered for patients who demonstrate positive response to a single bolus dose of Lioresal® Intrathecal (baclofen injection) during the screening test and one or more of the following:

  • Ineffective results or side effects (such as fatigue or nausea) from oral medications (spinal origin spasticity only)
  • Spasticity or spasms that interfere with function or daily activities
  • Spasticity or spasms that interfere with care or positioning
  • Spasticity-related pain

Lioresal Intrathecal is not recommended for intravenous, intramuscular, subcutaneous, or epidural administration.1 Hypersensitivity to oral baclofen is a contraindication to the intervention.1

Goal for Patient Selection

The overall goal for patient selection is to choose those patients most likely to experience therapeutic success while reducing the possibility of risks, complications, and adverse events.

A careful assessment and discussion of the patient's expectations and goals will help identify appropriate candidates for the intervention.

Exclusion Criteria

  • Presence of infection (at time of implant)
  • History of hypersensitivity to baclofen
  • Inability to comply with intervention maintenance (refills)
  • Pump cannot be implanted 2.5 cm or less from the surface of the skin
  • Body size not sufficient to accept pump bulk and weight
  • Less than 1-year post-injury (for traumatic brain injury only)
  • Have adequate response with acceptable side effects to oral baclofen therapy (spinal cord origin only)

Precautions1

Use ITB Therapy with care in patients who:

  • Use increased tone for functional value
  • Have trunk or cervical weakness
  • Have impaired renal function
  • Are pregnant or breastfeeding
  • Have a history of autonomic dysreflexia
  • Have a psychotic disorder or exhibit confusional state
  • Use central nervous system (CNS) depressants and/or alcohol
  • Have a history of uncontrolled seizures

Sample Treatment Goals for Spasticity Management

Treatment goals for spasticity management may include:

  • Improvement in functional independence
  • Improvements in the ability to perform activities of daily living
  • A reduction in spasticity that interferes with care and comfort
  • Facilitation of rehabilitation therapy
  • Prevention of spasticity-related complications such as pain, pressure ulcers, and joint contractures
  • Reduction in caregiver burden related to hygiene, transfers, and catheterization

References

  1. Lioresal® Intrathecal (baclofen injection) Drug Package Insert.

Considerations for Specific Patient Populations

Brain Injury

Spasticity is one of the most disabling aspects of brain injury1 and may be seen as early as a few days after brain injury or may take up to 3-6 months to develop.2 Spasticity occurs in about 25% of those living with traumatic brain injury;3 the incidence is up to 40% for those with mid-brain injuries.3

Clinicians should consider the following before making a recommendation for ITB Therapy:

  • Caregiver support system assessment is important in this population; particular attention should be paid to transportation for refills and family comprehension of overdose and underdose symptoms
  • Intrathecal baclofen therapy may assist in the ability of patients to participate in rehabilitation therapy
  • Those with spasticity due to traumatic brain injury should wait at least 1 year after the injury before consideration of long-term intrathecal baclofen therapy4

Cerebral Palsy

It is estimated that 70-80% of persons living with CP have spasticity,5 and at least 60% of those with spasticity have functional limitations.6 For children with severe movement disorders, oral medications or injection therapy are often inadequate, especially in children older than five or six.7

Clinicians should consider the following before making a recommendation for ITB Therapy:

  • Ensure pediatric patients have adequate body mass to accommodate the pump
  • Consider use of spasticity management interventions such as ITB Therapy before, or in conjunction with, orthopedic surgeries; note that the need for (or extent of) orthopedic surgery may be reduced or eliminated if ITB Therapy is used first, according to one study examining lower extremity spasticity8
  • Assess the social support system of pediatric patients and the independence level of adult patients

Multiple Sclerosis

Seventeen percent of people with MS have spasticity that frequently affects their activities of daily living.9

Clinicians should consider the following before making a recommendation for ITB Therapy:

  • Dose titration can optimize the necessary level of tone for independent and ambulatory patients
  • Disease progression may affect dose requirements
  • Some MS patients may be more sensitive to intrathecal baclofen effects, prompting some centers to trial ambulatory MS patients at a lower dose (for example, 25 mcg vs 50 mcg)10
  • Caregiver support system assessment is important in this population. Due to potential cognitive deficits, it's important that caregivers are able and willing to attend refill visits and understand symptoms of overdose and underdose10
  • Given the unpredictable, progressive nature of the disease, it may be important to regularly reassess goals
  • Fatigue is not a contraindication to rehabilitation following intrathecal baclofen therapy, but should be dosed accordingly

Spinal Cord Injury

Sixty-two percent of people with spinal cord injury (SCI) from cervical or thoracic injury reported having spasticity. Twelve percent reported having spasticity so severe that it interfered with activities of daily living.11

Clinicians should consider the following before making a recommendation for ITB Therapy:

  • Dose titration can optimize tone needed for transfers
  • Reduced spasticity may help to preserve sexual function in people with spinal cord injury according to anecdotal evidence12
  • Patients with a high-level injury or history of autonomic dysreflexia may pose a greater risk for complications4

Stroke

According to clinical evidence 38% of people experience spasticity within 1 year following a stroke.13

Clinicians should consider the following before making a recommendation for ITB Therapy:

  • Dose titration of independent and ambulatory patients can allow for retention of needed tone
  • A balance between overall tone and localized spasticity can be addressed through a complementary intervention, such as injection therapy
  • In one study on the use of intrathecal baclofen in stroke survivors, patients on anticoagulation medication showed no complications related to short-term discontinuation of the anticoagulation intervention before and after the procedure14.
  • In a clinical trial of patients with stroke-related spasticity, Meythaler et al. noted no complications related to short-term discontinuation of anticoagulant therapy in the 2 patients on anticoagulant therapy.
  • Lumbar punctures for the screening test were performed using a 25-gauge spinal needle (versus the usual 22-gauge) in these patients. Prothrombin times were monitored in these patients, who had their warfarin held for at least 3 days.14
  • A conversation about the risks and benefits of discontinuing anticoagulation medication should be conducted during the screening test and surgical procedure. Include patients and their caregivers in the conversation*

*No Medtronic-approved protocol exists for the discontinuation of anticoagulation medication during the screening test and surgical procedure. The decision to proceed should be based on an individual analysis of risks and benefits.

References

  1. Meythaler J, et al. Long-term continuously infused intrathecal baclofen for spastic dystonic hypertonia in traumatic brain injury: 1-year experience. Arch Phys Med Rehabil 1999; 80(1):13-19.
  2. Harben A. Medical conditions related to brain injury: Spasticity symptoms and treatment.  http://www.birf.info/home/library/med_cond/mci_spassys.html accessed 10/01/2008.
  3. Wedekind C, Lippert-Gruner M. Long-term outcome in severe traumatic brain injury is significantly influenced by brainstem involvement. Brain Inj 2005;19:681-4.
  4. Lioresal® Intrathecal (baclofen injection) Drug Package Insert.
  5. Centers for Disease Control and Prevention, www.cdc.gov, web site accessed 3/19/2008.
  6. Kennes J, Rosenbaum P, Hanna SE, et al. Health status of school-aged children with cerebral palsy: information from a population-based sample. Dev Med Child Neurol 2002; 44: 240–47.
  7. Albright AL. Neurosurgical treatment of spasticity and other pediatric movement disorders. J Child Neurol. 2003;18(supplement 1):S67-S78.
  8. Gerszten PC, Albright AL, Johnstone GF. Intrathecal baclofen infusion and subsequent orthopedic surgery in patients with spastic cerebral palsy. J Neurosurg. 1998;88(6):1009-1013.
  9. Rizzo MA, Hadjimichael OC, Preiningerova J, Vollmer TL. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler. 2004;10(5):589-595.
  10. Ridley B. Intrathecal baclofen therapy: challenges in patients with multiple sclerosis. Rehabil Nurs. 2006;31(4):158-164.
  11. Anson CA, Shepherd C. Incidence of secondary complications in spinal cord injury. Int J Rehabil Res. 1996;19(1):55-66.
  12. Ordia JI, Fischer E, Adamski E, Chagnon KG, Spatz EL. Continuous intrathecal baclofen infusion by a programmable pump in 131 consecutive patients with severe spasticity of spinal origin. Neuromod. 2002;5(1):16-24.
  13. Watkins CL, Leathley MJ, Gregson JM, Moore AP, Smith TL, Sharma AK. Prevalence of spasticity post stroke. Clin Rehabil. 2002:16(5):515-522.
  14. Meythaler JM, Guin-Refroe S, Brunner, RC, Hadley MN. Intrathecal baclofen for spastic hypertonia from stroke. Stroke. 2001;32(9):2099-2109.

Screening Test

Adverse events from the screening test may include hypotonia, somnolence, headache, dizziness and nausea/vomiting.

A standard screening test can determine whether ITB Therapy (Intrathecal Baclofen Therapy) is suitable for a patient with severe spasticity. In the test, the patient receives an intrathecally administered test dose of baclofen injection via a lumbar puncture.

Non-response to a low dose may require a trial with a higher dose to demonstrate patient benefit. There must be 24 hours between doses.

 

The screening test must be conducted in a medically supervised and adequately equipped environment with immediate access to resuscitative equipment.

Prior to the screening test, be sure to do the following:

  • Educate patient and caregiver regarding the screening test procedure
  • Consider titration or discontinuation of concomitant oral antispasmodic medications; some physicians only hold the daily dose on the day of screening
  • Prepare for the possibility of significant hypotonia during screening as a result of the bolus injection

Adverse events from the screening test may include hypotonia, somnolence, headache, dizziness, and nausea/vomiting.

Patient Selection Tools

Developed by the National Stroke Association, this scorecard can be used to help stroke survivors gauge their rehabilitation needs. It may be used to help facilitate discussions with physicians, therapists, and others involved in the ongoing care of the stroke survivor.

For more information on the indications, contraindications, warnings, and precautions for the SynchroMed programmable infusion systems, please review the device brief summaries for the SynchroMed II Drug Infusion System and the SynchroMed EL Infusion System.

ITB Therapy (Intrathecal Baclofen Therapy) is indicated for use in the management of severe spasticity. For spasticity of spinal cord origin, ITB Therapy via an implantable infusion system should be reserved for patients unresponsive to oral baclofen or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long-term intrathecal baclofen therapy.

Indications, Safety & Warnings for ITB Therapy: Intrathecal Baclofen Withdrawal: Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at risk (e.g., spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen).

This therapy is contraindicated in patients who are hypersensitive to baclofen. Implantation of the infusion system is contraindicated if the patient is of insufficient body size, requires a pump implant deeper than 2.5 cm, or, in the presence of spinal anomalies or active infection.

The most frequent drug adverse events vary by indication but include: hypotonia (34.7%), somnolence (20.9%), headache (10.7%), convulsion (10.0%), dizziness (8.0%), urinary retention (8.0%), nausea (7.3%), and paresthesia (6.7%). Pump system component failures leading to pump stall, or dosing/programming errors may result in clinically significant overdose or underdose. Acute massive overdose may result in coma and may be life threatening.

The most frequent and serious adverse events related to device and implant procedures are catheter dislodgement from the intrathecal space, catheter break/cut, and implant site infection including meningitis. Electromagnetic interference (EMI) and Magnetic resonance imaging (MRI) may cause patient injury, system damage, operational changes to the pump, and changes in flow rate.

Please refer to the full prescribing information and system information for details or call Medtronic at 1-800-328-0810. Rx Only. Lioresal® is a registered trademark of Novartis Pharmaceuticals Corporation.

January 2008