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ITB TherapySM

Patient Selection: ITB TherapySM and Brain Injury

Brent, living with brain injury. Receiving ITB Therapy.
Brent, living with brain injury. Receiving ITB Therapy since 1992.

Spasticity is one of the most disabling aspects of brain injury.1,2 Spasticity may interfere with mobility, use of residual motor function, transfers, sleep, and the overall rehabilitation and functional outcome of traumatic brain injury (TBI) patients.2 Cerebral-origin spasticity also may cause discomfort and deformity, and increased burden of care.3

In addition to the standard patient-selection criteria, clinicians may wish to consider the following when considering a person living with brain injury for ITB TherapySM (Intrathecal Baclofen 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
  • ITB 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 one year after the injury before consideration of long-term intrathecal baclofen therapy

1. Meythaler JM, McCary A, Hadley MN. Prospective assessment of continuous intrathecal infusion of baclofen for spasticity caused by acquired brain injury: a preliminary report. J Neurosurg. 1997;87(3):415-419.
2. Ordia JI, Fischer E, Adamski E, Spatz EL. Continuous intrathecal baclofen infusion delivered by a programmable pump for the treatment of severe spasticity following traumatic brain injury. Neuromod. 2002;5(2):103-107.
3. Gooch JL, Oberg WA, Grams B, Ward LA, Walker ML. Care provider assessment of intrathecal baclofen in children. Dev Med Child Neurol. 2004;46(8):548-552.

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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