Transcript 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.
References
1. Lance JW. Symposium Synopsis. Spasticity: Disordered Motor Control. Chicago, IL: Year Book Medical
Publishers; 1980:485-494.
2. Denny-Brown D. The Cerebral Control of Movement. Springfield, IL: Thomas; 1966.
3. Sanger TD, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW, Task Force on Childhood Motor Disorders.
Classification and definition of disorders causing hypertonia in childhood. Pediatrics 2003;111(1):e89-97.
4. Malhotra S, Pandyan AD, Day CR, Jones PW, Hermens H. Spasticity, an impairment that is poorly defined
and poorly measured. Clin Rehabil 2009;23(7):651-658.
5. Pandyan AD, Gregoric M, Barnes MP, et al. Spasticity: clinical perceptions, neurological realities and
meaningful measurement. Disabil Rehabil 2005;27(1-2):2-6.
6. Francois B, Vacher P, Roustan J, et al. Intrathecal baclofen after traumatic brain injury: early treatment
using a new technique to prevent spasticity. J Trauma 2001;50(1):158-161.
7. Francisco GE, Hu MM, Boake C, Ivanhoe CB. Efficacy of early use of intrathecal baclofen
therapy for treating spastic hypertonia due to acquired brain injury. Brain Inj 2005;19(5):359-364.
8. Meythaler JM, Guin-Renfroe S, Grabb P, Hadley MN. 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.
9. Bose P, Hou J, Nelson R, et al. Effects of acute intrathecal baclofen in an animal model of TBIinduced
spasticity, cognitive, and balance disabilities. J Neurotrauma 2013;30(13):1177-1191.
10. 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.
11. Lai LP, Reeves S, Smith BP, Kolaski K, Shilt JS. Use of intrathecal baclofen in a pediatric
cerebral palsy patient with refractory hemiplegia to maintain orthopaedic surgery gains. J Pediatr
Rehabil Med 2008;1(3):263-268.
12. Berman CM, Eppinger MA, Mazzola CA. Understanding the reasons for delayed referral for
intrathecal baclofen therapy in pediatric patients with severe spasticity. Childs Nerv Syst
2015;31(3):405-413.
References
13. Halpern R, Gillard P, Graham GD, Varon SF, Zorowitz RD. Adherence associated with oral
medications in the treatment of spasticity. PM & R 2013;5(9):747-756.
14. Medtronic. Lioresal Intrathecal (baclofen injection) Full Prescribing Information. Available at:
http://professional.medtronic.com/pt/neuro/itb/fpi/index.htm. 2013.
15. Elovic EP, Esquenazi A, Alter KE, Lin JL, Alfaro A, Kaelin DL. Chemodenervation and nerve
blocks in the diagnosis and management of spasticity and muscle overactivity. PM & R 2009;1(9):842-851.
16. Meythaler JM, Guin-Renfroe S, Hadley MN. Continuously infused intrathecal baclofen for
spastic/dystonic hemiplegia: a preliminary report. Am J Phys Med Rehabil 1999;78(3):247-254.
17. Dario A, Di Stefano MG, Grossi A, Casagrande F, Bono G. Long-term intrathecal baclofen
infusion in supraspinal spasticity of adulthood. Acta Neurol Scand 2002;105(2):83-87.
18. Horn TS, Yablon SA, Stokic DS. Effect of intrathecal baclofen bolus injection on temporospatial
gait characteristics in patients with acquired brain injury. Arch Phys Med Rehabil 2005;86(6):1127-1133.
19. Zahavi A, Geertzen JH, Middel B, Staal M, Rietman JS. Long term effect (more than five years)
of intrathecal baclofen on impairment, disability, and quality of life in patients with severe
spasticity of spinal origin. J Neurol Neurosurg Psychiatry 2004;75(11):1553-1557.
20. Plassat R, Perrouin Verbe B, Menei P, Menegalli D, Mathe JF, Richard I. Treatment of spasticity with
intrathecal baclofen administration: long-term follow-up, review of 40 patients. Spinal Cord2004;42(12):686-93.
21. Gerszten PC, Albright AL, Barry MJ. Effect on ambulation of continuous intrathecal baclofen infusion.
Pediatr Neurosurg 1997;27(1):40-44.
22. Chow JW, Yablon SA, Stokic DS. Effect of intrathecal baclofen bolus injection on ankle muscle
activation during gait in patients with acquired brain injury. Neurorehabil Neural Repair 2015;29(2):163-173.
23. Fasano VA, Broggi G, Barolat-Romana G, Sguazzi A. Surgical treatment of spasticity in cerebral
palsy. Childs Brain. 1978;4(5):289-305.
References
24. Guerrera S, Morabito R, Baglieri A, et al. Cortical reorganization in multiple sclerosis after
intrathecal baclofen therapy. Neurocase 2014;20(2):225-229.
25. Bethoux F, Boulis N, McClelland S, et al. Use of intrathecal baclofen for treatment of severe
spasticity in selected patients with motor neuron disease. Neurorehabil Neural Repair 2013;27(9):828-833.
26. Erwin A, Gudesblatt M, Bethoux F, et al. Intrathecal baclofen in multiple sclerosis: too little, too
late? Multiple Sclerosis 2011;17(5):623-629.
27. Coffey RJ, Cahill D, Steers W, et al. Intrathecal baclofen for intractable spasticity of spinal
origin: results of a long-term multicenter study. J Neurosurg 1993;78(2):226-232.
28. Avellino AM, Loeser JD. Intrathecal baclofen for the treatment of intractable spasticity of spine
or brain etiology. Neuromodulation 2000;3(2):75-81.
29. Stempien L, Tsai T. Intrathecal baclofen pump use for spasticity: a clinical survey. Am J Physical Med
Rehabil 2000;79(6):536-541.
30. Vles GF, Soudant DL, Hoving MA, et al. Long-term follow-up on continuous intrathecal baclofen therapy in
non-ambulant children with intractable spastic cerebral palsy. Eur J Paediatr Neurol 2013;17(6):639-644.
31. Ridley B, Rawlins PK. Intrathecal baclofen therapy: ten steps toward best practice. J Neurosci Nurs
2006;38(2):72-82.
32. Graham HK, Aoki KR, Autti-Ramo I, et al. Recommendations for the use of botulinum toxin type
A in the management of cerebral palsy. Gait Posture 2000;11(1):67-79.
33. Fulkerson DH, Boaz JC, Luerssen TG. Interaction of ventriculoperitoneal shunt and baclofen
pump. Childs Nerv Syst 2007;23(7):733-738.
34. Turner MS. Assessing syndromes of catheter malfunction with SynchroMed infusion systems: the
value of spiral computed tomography with contrast injection. PM & R 2010;2(8):757-766.
35. Buonaguro V, Scelsa B, Curci D, Monforte S, Iuorno T, Motta F. Epilepsy and intrathecal
baclofen therapy in children with cerebral palsy. Pediatr Neurol 2005;33(2):110-113.
36. Schuele SU, Kellinghaus C, Shook SJ, Boulis N, Bethoux FA, Loddenkemper T. Incidence of
seizures in patients with multiple sclerosis treated with intrathecal baclofen. Neurology
2005;64(6):1086-1087