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ITB TherapySM

Patient Selection: ITB TherapySM and Multiple Sclerosis

Diana, living with MS. Receiving ITB Therapy
Diana, living with MS. Receiving ITB Therapy since 2000.

Thirty-four percent of people with MS have spasticity that interferes with daily living.1 In addition to the standard patient-selection criteria, clinicians may wish to consider the following when considering a person living with MS for ITB TherapySM (Intrathecal Baclofen Therapy):

  • Fatigue can be a big challenge for people living with MS. If ITB Therapy can make their gait more efficient, this may be a benefit in alleviating some fatigue
  • Caregiver support system assessment is important in this population. Due to potential cognitive deficits, it is important that caregivers, when used, are able and willing to attend refill visits and understand symptoms of overdose and underdose2
Other Considerations
  • Dose titration can optimize the necessary level of tone for independent and ambulatory patients
  • Disease progression may affect dose requirements
  • Goals for these patients may include:
    • Improve, or at least preserve, ability to stand and walk
    • Reduce disability with respect to driving, mobility, work, and leisure activities
    • Facilitate self care
  • Given the unpredictable, progressive nature of the disease, it may be important to regularly reassess goals3
  • Fatigue is not a contraindication to rehabilitation following ITB Therapy, but therapy should be dosed accordingly

1. 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.
2. Ridley B. Intrathecal baclofen therapy: challenges in patients with multiple sclerosis. Rehabil Nurs. 2006;31(4):158-164.
3. Centers for Disease Control and Prevention, www.cdc.gov, web site accessed 3/19/08

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.

Important Safety Information 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.


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