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ITB TherapySM

Patient Selection: ITB TherapySM and Stroke

Mary C., stroke survivor. Receiving ITB Therapy since 2003
Mary C., stroke survivor. Receiving ITB Therapy since 2003.

Clinical evidence cites 38% of people experience spasticity within one year following a stroke.1 In addition to the standard patient-selection criteria clinicians may wish to consider the following when considering a stroke survivor for ITB TherapySM (Intrathecal Baclofen 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 by use of a complementary intervention, such as injection therapy
  • In one study, stroke survivors on anticoagulation medication demonstrated no complications related to short-term discontinuation of the anticoagulation therapy before and after the procedure3
  • Discuss the risks and benefits of discontinuing anticoagulation medication during the screening test and surgical procedure with patients and their caregivers

It is important to note that no Medtronic-approved protocol exists for the discontinuation of anticoagulation medication during the screening test and surgical procedure and the decision to proceed rests on an individual analysis of risks and benefits. However, 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 two 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 anticoagulants such as warfarin, sodium, aspirin, clopidogrel, or ticlopidine held for at least three days.2


1. Watkins CL, Leathley MJ, Gregson JM, Moore AP, Smith TL, Sharma AK. Prevalence of spasticity post stroke. Clin Rehabil. 2002:16(5):515-522.
2. Meythaler JM, Guin-Refroe S, Brunner, RC, Hadley MN. Intrathecal baclofen for spastic hypertonia from stroke. Stroke. 2001;32(9):2099-2109.

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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