Download Functional Anatomy and MRI of the Motor System

Best Practices for
ITB Therapy:
Patient Selection
Cindy Ivanhoe, MD, John McGuire, MD
Barbara Ridley, MD Michael Saulino, MD PhD
Jeff Shilt, MD
Disclosures
• Consultant, Research and Educational
grants from Medtronic, Mallinckrodt
ITB FDA Indication
• Management of severe
spasticity of spinal and
cerebral origins.
• Any patient who demonstrates
spasticity that interferes with
comfort, active or passive
function, activities of daily
living, mobility, positioning, or
caregiver assistance should be
considered for interventions
including ITB therapy
Patient Selection
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Define Severe Spasticity
Timing
Influential Factors
Patient/Family Education
Goal Setting
Failure
Contraindications
Conclusions
Spasticity
• “Disordered sensori-motor control,
resulting from an upper motor neuron
lesion, presenting as intermittent or
sustained involuntary activation of
muscles.” (Pandyan, 2005, SPASM consortium)
• Measure abnormal muscle activity not
“stiffness”
• Includes clonus, cocontraction, associated
reactions, dystonia, and spasms
Severe Spasticity
• Degree of functional limitation to the
patient/caregiver.
• How Problematic is it?
• Resistance to passive stretch does not
always correlate with functional impact
• Inability to perform basic ADL’s:
hygiene, dressing, and toileting.
• Cause pain, interrupt sleep, negatively
impact mood, and impair mobility.
Timing of Intervention
• FDA label requires waiting one year after
TBI before ITB therapy. “Too Restrictive”
• Earlier Treatment safe/effective in
appropriate patients. (Francois, 2001, Francisco, 2005,
Meythaler, 1999)
• Musculoskeletal consequences in delayed or
nonintervention, including contracture,
ankylosis, and skin breakdown. (Gerszten, 1998,
Lai, 2008, Berman, 2015)
• Weigh risk vs benefits of early vs late
Complimentary Treatments
• Rehabilitation treatments
• Focal/Segmental Treatments
– Nerve/Motor point blocks
– Tendon transfer/lengthening
• Generalized Treatments:
– Oral/Intrathecal medications
– Rhizotomy
Ambulatory Patients
• ITB may improve the
ambulation status or gait
performance with concurrent
intensive therapy.
• Improvements in isolated cases
(Meythaler, 1999, Dario, 2002, Horn, 2005)
• Larger studies mixed results
(Zahavi, 2004, Plassat, 2004, Gerszten, 1997,
Chow, 2015)
Pediatric Patients
• Spasticity during rapid growth prevents
normal bone and muscle development
causing muscle shortening, joint
dislocations, poor motor function.
• Early treatment of spasticity reduces the
need for orthopedic surgery for
contracture or torsion deformity in
children with severe spasticity from
cerebral palsy. (Gerszten, 1998)
Pediatric Patients
• Preoperative discussion should include
baseline evaluations for scoliosis, hip
status, hydrocephalus, and urodynamic
status.
• Impact of ITB on scoliosis development
or progression is controversial.
• No prospective, matched cohort studies
Progressive Disease States
• MS or progressive muscular dystrophies,
who are implanted prior to significant
joint contracture formation, weakness, or
muscle imbalance, might demonstrate
maintenance of function for longer
periods. (Guerrera, 2014, Bethoux, 2013, Erwin, 2011)
• Early exposure to ITB therapy is
warranted to prevent musculoskeletal
ramifications of spasticity.
Other Considerations
• ITB provides spasticity control while
avoiding cognitive side effects of oral
medications.
• Environmental infrastructure,
• Individual desire and motivation to
participate in necessary therapy and
lifestyle changes,
• Appropriate level of residual neurologic
ability following injury, and access to
appropriate care.
Goal Setting
• Meaningful to patient/caregiver.
• Use common language and approach
• Integrates the psychosocial, physical,
medical, biomechanical, and functional
aspects of each patient.
• What matters most to the patient/caregiver
Goals: Improved Body
Function & Structure
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Improved skin integrity
Improved standing capacity
Improved or maintained range of motion
Improved orthotic tolerance
Reduced startle response
Reduced musculoskeletal pain
Goals Improved Participation
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Improved endurance
Improved standing capacity
Improved ambulation speed
Improved sitting balance/tolerance
Improved orthotic tolerance
Improved cosmesis
Reduced need for oral anti-spasticity
medications
Goals: Improved ADL’s
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Improved ease of hygiene
Improved standing capacity
Improved ambulation speed
Improved quality of ambulation
Improved sitting balance/tolerance
Reduced falls
Failure of Other Therapies
• Consider the least invasive options first
• Unresponsiveness to oral medications or
failure of less invasive options should not be
mandated before exploring ITB therapy.
• Many patients who could benefit from ITB
have a suboptimal response or inadequate
therapeutic benefit from oral medications.
• Combined therapies depict the most
reasonable approach compared to
hierarchical or compartmentalized models
Synergistic Model of Spasticity
Management
Intrathecal
Baclofen
(ITB™)
Therapy
Oral
Medications
Orthopedic
Surgery
Patient
Neurosurgery
Injection
Therapy
NonPharmaclogical
Absolute Contraindications
• True allergy to baclofen
• Active infection
– Chronic colonization (bladder, decub
ulcer) can be implanted in selective
cases; consider ID consultation.
Relative Contraindications
• Unrealistic goals by the patient/caregivers
• Unmanageable mental health issues,
• Psychosocial factors (i.e., unreliable
transportation, inconsistency in keeping
appointments, frequently changing phone
numbers, etc.)
• Financial burden
• Modifiable with case manager or social
worker
Summary of Best Practices
• Severe spasticity: unduly troublesome/problematic to
patients or caregivers.
• ITB therapy should be considered in all patients with
inadequately controlled, problematic spasticity, in all
phases of disease processes.
• ITB therapy effective improving ambulatory function in
certain patients. Rehabilitative therapy should be
applied concomitantly.
• ITB therapy is a highly effective tool for spasticity
reduction in the pediatric population. Baseline
evaluations for scoliosis, hip status, hydrocephalus, and
urodynamic status.
Summary of Best Practices
• ITB should be considered early to potentially
avoid or delay musculoskeletal and functional
consequences of spasticity.
• Patient/family/caregiver education is crucial
• Goal setting is necessary for patients and
clinicians to approach the utilization of ITB
therapy in a meaningful and effective way.
• Must consider the absolute and relative
contraindications and develop appropriate
strategies for each issue.
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