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Best Practices for ITB Therapy: Patient Selection

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.

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Best Practices for ITB Therapy: Patient Selection

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  1. Best Practices for ITB Therapy: Patient Selection Cindy Ivanhoe, MD, John McGuire, MD Barbara Ridley, MD Michael Saulino, MD PhD Jeff Shilt, MD

  2. Disclosures • Consultant, Research and Educational grants from Medtronic, Mallinckrodt

  3. 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

  4. Patient Selection • Define Severe Spasticity • Timing • Influential Factors • Patient/Family Education • Goal Setting • Failure • Contraindications • Conclusions

  5. 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

  6. 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.

  7. 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

  8. Complimentary Treatments • Rehabilitation treatments • Focal/Segmental Treatments • Nerve/Motor point blocks • Tendon transfer/lengthening • Generalized Treatments: • Oral/Intrathecal medications • Rhizotomy

  9. 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)

  10. 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)

  11. 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

  12. 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.

  13. 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.

  14. 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

  15. Goals: Improved Body Function & Structure • Improved skin integrity • Improved standing capacity • Improved or maintained range of motion • Improved orthotic tolerance • Reduced startle response • Reduced musculoskeletal pain

  16. Goals Improved Participation • Improved endurance • Improved standing capacity • Improved ambulation speed • Improved sitting balance/tolerance • Improved orthotic tolerance • Improved cosmesis • Reduced need for oral anti-spasticity medications

  17. Goals: Improved ADL’s • Improved ease of hygiene • Improved standing capacity • Improved ambulation speed • Improved quality of ambulation • Improved sitting balance/tolerance • Reduced falls

  18. 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

  19. Synergistic Model of Spasticity Management Patient IntrathecalBaclofen (ITB™) Therapy Oral Medications Orthopedic Surgery Neurosurgery Injection Therapy Non- Pharmaclogical

  20. Absolute Contraindications • True allergy to baclofen • Active infection • Chronic colonization (bladder, decub ulcer) can be implanted in selective cases; consider ID consultation.

  21. 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

  22. 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.

  23. 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.

  24. 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. ClinRehabil 2009;23(7):651-658. 5. Pandyan AD, Gregoric M, Barnes MP, et al. Spasticity: clinical perceptions, neurological realities and meaningful measurement. DisabilRehabil 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 NervSyst 2015;31(3):405-413.

  25. 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. LioresalIntrathecal (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. ActaNeurolScand 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 NeurolNeurosurg Psychiatry 2004;75(11):1553-1557. 20. Plassat R, PerrouinVerbe 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 intrathecalbaclofen infusion. PediatrNeurosurg 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.

  26. 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 PaediatrNeurol 2013;17(6):639-644. 31. Ridley B, Rawlins PK. Intrathecal baclofen therapy: ten steps toward best practice. J NeurosciNurs 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 NervSyst 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. PediatrNeurol 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

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