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Intrathecal Baclofen Therapy

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  • Patient Selection

    There are many factors critical to the success of ITB TherapySM (intrathecal baclofen therapy). One of the most important is patient selection.

    Details

    Choosing a treatment option for managing severe spasticity depends on the severity of symptoms and efficacy of the current therapy as determined during the patient assessment process. Treatment typically begins with noninvasive therapies and, if unsuccessful, moves to more interventional treatment options. Often, several therapies are used together for optimum benefit to the patient.

    treatment-fig1
    Figure 1. Treatment Options for Spasticity Management

    Figure 1 depicts the major categories of treatment options used to treat severe spasticity while Figure 2 denotes each therapy’s role based on treatment effect and permanence.

    treatment-fig2
    Figure 2. Treatment Options According to Treatment Effect and Permanence

    Severe spasticity can be treated separately from the patient's primary underlying condition. Effective treatment of spasticity may:

    • Improve gait, hygiene, ease of care
    • Decrease spasm frequency, pain, fatigue
    • Promote tone reduction, increase range of motion
    • Complement physical, occupational, and speech therapies

    In many cases, severe spasticity may be adequately managed with oral medication, rehabilitative interventions, and/or injection therapy. For some patients, however, these treatments do not provide sufficient relief, or they result in intolerable side effects. For example, oral drugs at effective doses for managing spasticity may cause severe drowsiness, dizziness, weakness, and nausea, which can limit participation in family, social, academic, and/or work-related activities.

    Patients who are unresponsive to oral baclofen or who experience intolerable central nervous system (CNS) side effects from oral baclofen may benefit from ITB Therapy. ITB Therapy can significantly decrease severe spasticity1-9 and spasms.2, 7-9

    Who Can Benefit?

    ITB Therapy for the management of severe spasticity should be considered for patients who demonstrate a 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.11 Hypersensitivity to oral baclofen is a contraindication to the therapy.11

    Consider ITB Therapy for patients who experience one or more of the following:

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

    Goal of Patient Selection

    The overall goal for patient selection for ITB Therapy is to choose those patients most likely to experience therapeutic success while reducing the likelihood 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 therapy.

    Exclusion Criteria

    • Presence of infection at time of implant
    • History of hypersensitivity to oral baclofen
    • Inability to comply with therapy 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)
    • Responsive to oral baclofen therapy or experience tolerable side effects at effective doses
    • Spinal anomalies
    • Patient less than 4 years old

    Precautions10

    Use ITB Therapy with care in patients who11:

    • 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 depressants and/or alcohol
    • Have a history of uncontrolled seizures
    References
    1. Francisco GC, Boake C. Improvement in walking speed in poststroke spastic hemiplegia after intrathecal baclofen therapy: a preliminary study. Arch Phys Med Rehabil. 2003;84(8):1194-1199.
    2. Meythaler JM, Guin-Refroe S, Brunner RC, Hadley MN. Intrathecal baclofen for spastic hypertonia from stroke. Stroke. 2001;32(9):2099-2109.
    3. Ivanhoe CB, Francisco GE, McGuire JR, Subramanian T, Grissom SP. Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life. Arch Phys Med Rehabil. 2006;87(11):1509–1515.
    4. Gilmartin R. Intrathecal baclofen for management of spastic cerebral palsy: multicenter trial. J Child Neurol. 2000;15(2):71-77.
    5. Hoving MA, van Raak EP, Spincemaille GH, Palmans LJ, Becher JG, Vles JS; Dutch Study Group on Child Spasticity. Efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy: a randomised controlled trial. Eur J Paediatr Neurol. 2009;13:240-246.
    6. Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years of experience. J Neurosurg. 1992;77(2):236-240.
    7. Albright AL, Gilmartin R, Swift D, Krach LE, Ivanhoe CB, McLaughlin JF. Long-term intrathecal baclofen therapy for severe spasticity of cerebral origin. J Neurosurg. 2003;98(2):291-295.
    8. Coffey RJ, Cahill D, Steers W. Intrathecal baclofen for intractable spasticity of spinal origin: results of a long-term multicenter study. J Neurosurg. 1993;78(6):226-232.
    9. 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. Neuromodulation. 2002;5(1):16-24.
    10. Becker R, Alberti O, Bauer BL. Continuous intrathecal baclofen infusion in severe spasticity after traumatic or hypoxic brain injury. J Neurol 1997; 224(3): 160-166
    11. Lioresal Intrathecal (baclofen injection) Drug Package Insert.

    Spasticity Assessment

    Proper diagnosis is critical for determining the most effective management of severe spasticity. The rehabilitation team can provide valuable insights in the assessment of patients with severe spasticity during various stages of evaluation, screening, and follow-up.

    Individuals with severe spasticity present with a broad range of functional levels ranging from ambulatory and high functioning to total dependence for all activities of daily living (ADLs). Appropriate and thorough assessment of the individual's impairments and capabilities serve to provide a baseline for realistic goal setting for a therapy. Assessment tools are also useful for evaluating a therapy's effectiveness over time.

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    Standardizing Assessment for Spasticity Management

    (19:39)

    Demonstration of the standard functional assessments and underlying impairment testing used in spasticity management.

    Functional Assessment: Patient 1

    (11:36)

    Functional testing of a patient with congenital hydrocephelus, cerebral palsy, and right cerebral vascular accident.

    Functional Assessment: Patient 2

    (6:10)

    Functional testing of a non-ambulatory patient with multiple sclerosis.

    Functional Assessment: Patient 3

    (1:08)

    Functional testing of an ambulatory patient with multiple sclerosis.

     

    Patient Assessment

    The patient selection phase for ITB Therapy involves assessment of a patient's clinical conditions and psychosocial situation by multidisciplinary team members.

    The key tasks involved in assessing patients for ITB Therapy include:

    The Patient Selection Algorithm provides a roadmap to review indications and contraindications for help in the selection of patients for ITB Therapy for the management of severe spasticity of cerebral and spinal origin.

    Several assessment tools and scales are available for standardizing assessment for spasticity management. These include a variety of scales, questionnaires, inventories, indices, and other tools.

    Refer to the Severe Spasticity Management chapter of the SynchroMed Programmable Infusion Systems Clinical Reference Guide for detailed information and procedures on patient assessment for ITB Therapy.

    Review Patient Selection Criteria

    Candidates for ITB Therapy are patients who have:

    • A diagnosis of severe spasticity
    • Become refractory to oral baclofen or experienced intolerable side effects at effective doses (spasticity of spinal origin only)
    • Demonstrated positive response to a single bolus dose of Lioresal® Intrathecal (baclofen injection)
    • Waited at least 1 year after a traumatic brain injury

    Clinical Considerations

    Prior Procedures – Prior soft-tissue lengthening procedures, tendon releases, and selective posterior rhizotomy are not contraindications to ITB Therapy.

    Seizures – A history of seizures is not a contraindication to ITB Therapy.

    Presence of Other Devices – The presence of a ventriculoperitoneal (VP) shunt is not a contraindication to ITB Therapy. The telemetry signals produced by the pump programmer can cause sensing problems and inappropriate device responses with an implantable pacemaker or defibrillator.

    Trunk and Cervical Weakness – Among patients who have significant trunk or cervical weakness, spasticity or increased tone may be necessary for stabilization and maintenance of appropriate posture. The benefits of baclofen in reducing spasticity must be carefully weighed against the potential for loss of patient’s function if trunk or cervical tone is reduced.

    Considerations for Particular Patient Conditions and Situations
    Precautions for using Lioresal Intrathecal (baclofen injection) should be taken with patients with the following conditions:

    • Autonomic dysreflexia
    • Impaired renal function
    • Psychotic disorders, schizophrenia, or confusional states
    • Pregnancy (Lioresal Intrathecal is pregnancy category C)
    • Nursing mothers
    • Pediatric patients

    Use of ITB Therapy is contraindicated:

    • If the patient has a history of allergy to oral baclofen
    • In the presence of infection
    • When the pump cannot be implanted 2.5 cm or less from the surface of the skin
    • In patients whose body size is not sufficient to accept pump bulk and weight
    • In the presence of spinal anomalies

     

    Select the Patient

    Patient assessment is an essential step prior to selecting candidates for ITB Therapy. Ideally, an interdisciplinary team conducts the assessment so that all facets of the patient’s condition can be considered.

    Key Tasks for Selecting the Patient:

    • Conduct a complete patient history and physical examination
    • Evaluate the spasticity, spasms, clonus, and underlying strength
    • Assess orthotic and other equipment needs

    Consult with caregivers and conduct additional patient assessment as needed to determine:

    • Level of independence
    • Difficulty in care giving tasks
    • Functional status
    • Activities of daily living (ADL)
    • Social support structure
    • Determine current medication use, including antispasmodics
      • Assess history of drug side effects and adverse events
    • Establish realistic goals with patient, family, caregivers, and an interdisciplinary spasticity management team
    • Identify ITB Therapy candidates

    Establish Treatment Goals

    Treatment goals must be realistic given the patient's current level of function and disability. Examples of spasticity management goals include:

    • Improvement in functional independence
    • Improvement 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 and pressure ulcers
    • Reduction in a caregiver burden related to hygiene and transfers

     

    Provide Patient and Caregiver Education

    Patient education is critical to managing patient expectations and the long-term success of ITB Therapy. Education begins at the initial assessment and continues throughout all phases of ITB Therapy. The patient, family, and caregiver need to understand the need for commitment to ITB Therapy, including the importance of keeping refill appointments, reporting unusual or unexpected symptoms, obtaining physical therapy, and other.

    Refer to Patient Education Checklist for Screening for ITB Therapy in the appendix of the SynchroMed Programmable Infusion Systems Clinical Reference Guide for a detailed checklist of key patient education topics.

    Two features of ITB Therapy using the SynchroMed II infusion system that should be kept in mind during the patient selection process are:

    • Flexible dosing patterns
    • Reversibility of treatment

     

    Considerations by Condition

    All candidates for ITB Therapy must meet the patient selection criteria. In addition, clinicians should consider additional selection criteria related to the patient's underlying condition.

    Brain Injury

    Spasticity is one of the most disabling aspects of brain injury.1 Spasticity occurs in about 25% of those living with traumatic brain injury;2 the incidence is up to 40% for those with mid-brain injuries.2

    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 severe spasticity due to traumatic brain injury should wait at least 1 year after the injury before consideration of long-term intrathecal baclofen therapy.3

    Cerebral Palsy

    It is estimated that 70-80% of persons living with CP have spasticity,4 and at least 60% of those with spasticity have functional limitations.5 For children with severe movement disorders, oral medications or injection therapy are often inadequate, especially in children older than five or six.6

    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 severe spasticity management therapies 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 spasticity.7
    • 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.8

    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, which can be addressed by adjusting the programming of the drug pump.
    • 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 underdose.
    • 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.9

    Clinicians should consider the following before making a recommendation for ITB Therapy:
    • Dose titration can optimize tone needed for transfers.
    • Patients with a high-level injury or history of autonomic dysreflexia may pose a greater risk for complications.3

    Stroke

    According to clinical evidence 38% of people experience spasticity within 1 year following a stroke.10

    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 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.11
      • 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.11
    • 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. 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.
    3. Lioresal™ Intrathecal (baclofen injection) Drug Package Insert.
    4. Centers for Disease Control and Prevention, www.cdc.gov, web site accessed 3/19/2008.
    5. 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.
    6. Albright AL. Neurosurgical treatment of spasticity and other pediatric movement disorders. J Child Neurol. 2003;18(supplement 1):S67-S78.
    7. 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.
    8. 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.
    9. Anson CA, Shepherd C. Incidence of secondary complications in spinal cord injury. Int J Rehabil Res. 1996;19(1):55-66.
    10. Watkins CL, Leathley MJ, Gregson JM, Moore AP, Smith TL, Sharma AK. Prevalence of spasticity post stroke. Clin Rehabil. 2002:16(5):515-522.
    11. Meythaler JM, Guin-Refroe S, Brunner, RC, Hadley MN. Intrathecal baclofen for spastic hypertonia from stroke. Stroke. 2001;32(9):2099-2109.

    Screening Test

    A standard screening test is required to determine whether ITB Therapy may be suitable as a treatment option for their severe spasticity. In the test, patients receive a bolus dose of baclofen injection via a lumbar puncture, and the patient’s response is evaluated.

    A majority of patients who respond favorably go on to receive ITB Therapy long term. Nonresponse 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.

    • 97% of patients with spasticity of spinal origin demonstrate a positive response to the screening test in one clinical study.1
    • 94% of patients with spasticity of cerebral origin demonstrate a positive response to the screening test in one clinical study.2

     

    Responsibilities Before the Screening Test

    • Educate patient and caregiver regarding the screening test procedure
    • Establish a baseline assessment prior to the bolus injection
    • Consider titration or discontinuation of concomitant oral antispasmodic medications. Some physicians hold the daily dose only on the day of screening
    • Prepare for the possibility of significant hypotonia during screening as a result of the bolus injection. This should not be interpreted as a failed screening test; however, underlying muscle strength and weakness should be assessed

    Screening Procedure

    screen-test
    ITB Therapy Screening Test Algorithm

    A typical screening procedure for ITB Therapy:

    • Administer an initial screening test dose of Lioresal® Intrathecal (baclofen injection) of 50 mcg. For very small pediatric patients, a screening dose of 25 mcg may be tried first
    • Drug effects usually begin 30-60 minutes after the bolus
    • Peak effect occurs approximately 4 hours after the bolus dose and the effect may last 4-8 hours
    • Monitor the patient for a minimum of 4-8 hours and observe for response
    • Continue to monitor the patient until spasticity begins to return to baseline
    • During the first few hours following the lumbar puncture, the patient should lie flat to minimize the possibility of a cerebrospinal fluid leak, which could cause nausea, vomiting, and/or spinal headache
    • Determine the patient’s response by evaluating changes in muscle spasticity and spasms. Reassessments can be done at 1, 2, and 4 hours post injection
    • If the clinical response is less than desired, a second bolus injection of 75 mcg may be administered NO LESS THAN 24 hours after the first bolus. (Adjust dose accordingly if the initial dose is 25 mcg)
    • Again, monitor the patient for a minimum of 4-8 hours and observe the patient for response. Continue to monitor until the patient’s spasticity begins to return to baseline
    • Repeat for 100 mcg as needed
    • DO NOT EXCEED a bolus dose of 100 mcg. Patients who don’t respond to a 100 mcg bolus of Lioresal Intrathecal (baclofen injection) should not be considered candidates for ITB Therapy. An acceptable response should be determined for each patient in advance of the screening test
    • Possible adverse events of the screening test are drug related and include hypotonia, somnolence, nausea, vomiting, headaches, and dizziness. Ask your patients to indicate if they experience any of these potential events
    • A screening test is contraindicated in the presence of active infection and in patients who demonstrate hypersensitivity to oral baclofen
    • If you have patients who may be candidates for ITB Therapy and you are interested in having them undergo a screening test, contact your Medtronic representative or call Medtronic at (800) 328-0810

    Refer to the Patient Education Checklist for Screening for ITB Therapy in the appendix of the SynchroMed Programmable Infusion Systems Clinical Reference Guide for information on patient and caregiver education for the ITB Therapy screening test. Refer to the Severe Spasticity Management chapter for detailed information and procedures on the patient screening test for ITB Therapy, including withdrawal from oral antispasmodics and measurement tools for evaluating the screening test outcome.

     

    References
    1. Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years of experience. J Neurosurg. 1992;77(2):236-240.
    2. Gilmartin R. Intrathecal baclofen for management of spastic cerebral palsy: multicenter trial. J Child Neurol. 2000;15(2):71-77.

    Tools and Resources

    Patient Selection Tools

    SynchroMed Programmable Infusion Systems Clinical Reference Guide

    The Severe Spasticity Management chapter includes detailed information and procedures on patient selection and screening for ITB Therapy. Tools include a checklist for patient and caregiver education, a screening test assessment form, guidelines for patient withdrawal from oral antispasmodics, and other tools for the ITB Therapy screening test.

    ITB Resource Center

    These guidelines and downloads can help centers manage spasticity consultations and ITB screening tests.

    Patient Assessment Tools

    How Spasticity Is Affecting You

    This form is completed by the patient and caregiver. It gives a picture of the impact of spasticity on the patient’s life with current treatments.

    Assessment Tools and Scales

    Several tools are available for standardizing assessment for spasticity management including a variety of scales, questionnaires, inventories, indices, and other tools.

    Task List for Screening Test

    Downloadable version of team tasks to prepare for and conduct a screening test.

    Screening Test Results

    This is a template to document the results of a patient's screening test.

    ITB Therapy (Intrathecal Baclofen Therapy) is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. 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). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information.

     

    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 (800) 328-0810.

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