Candidates/Selection Criteria:

STEP 1: Selection Criteria

Spasticity is: Severe and interfering with care or function; causing complications.
Patient is: = or > 4 years of age, clinically stable or not rapidly progressive, with a body weight sufficient to support pump (> or = 20lbs).
Family is: motivated, committed, reliable, reasonable, cooperative.
Goals are: explicit, collective, realistic, appropriate, mutually agreed upon.

PATIENT SELECTION:

Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Stiff Person Syndome, Primary Lateral Sclerosis, Leukodystrophy, Familial Spastic Paraparesis, Spinal Cord Injury, Transverse Myelitis, Compressive Myelopathy, Spinal Cord Stroke

Stroke, Cerebral Hemmorhage, Traumatic Brain Injury, Cerebral Palsy, Anoxic Encephalopathy, Stiff Person Syndrome, Encephalitis, Near Drowning

Dystonia with Spasticity

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Candidates/Selection Criteria

STEP 2: Exclusion Criteria

• Infection or Pregnancy.
• History of allergy or hypersensitivity to baclofen
  

STEP 3: General Clinical considerations:

Critical issues to be considered:

• Unique features of ITB therapy are: graduated control of spasticity, upper extremity treatment, reversibility.
• ITB therapy may decrease trunk and cervical tone.
• Successful outcome depends on conscientious followup and pump maintenance.
• Are these features important to this patient?
• Will this outcome compromise the patients posture or stability?
• Does this patient/family caregiver unit possess the necessary motivation and reliability to maintain the pump?

Questions to ask before & during screening process:

• Is the functional impairment a result of spastic hypertonia?
• Is there a gait disturbance?
• Do spasms force the patient from his/her chair?
• Do spasms interrupt normal sleeping pattern?
• Does the patient rely on tone for present motor function?
• Is perceived “loss of strength” actually loss of tone or loss of strength?
• Will the same therapist be present throughout the entire screening process?
  

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SPINAL SPASTICITY

SPINAL SPASTICITY- selection criteria for intrathecal baclofen therapy

• Moderate to severe spasticity resulting in functional disability, pain, or deformity.
• underlying neurological condition irreversible and/or ‘stable’.
• adequate trial with all available oral drugs are ineffective at maximum doses or result in unacceptable adverse effects.
• guardian / patient understand potential risks, benefits, and need to follow up.
  

SPINAL SPASTICITY - need for ITB therapy in spinal cord injury (SCI)

• Spasticity develops in approximately 70% of all patients with SCI.
• About 30% of all patients on oral medications have inadequate clinical response.
• ITB should be considered early in rehabilitation once condition has stabilized (3-6 months post-injury).

SPINAL SPASTICITY - need for ITB therapy in multiple sclerosis

• Within the first ten years of diagnosis 70% of patients have lower limb and 40% have upper limb spasticity.
• Over time almost all symptomatic patients develop spasticity.
• Male patients with MS develop spasticity earlier and more frequently than females.
• Early treatment (especially in patients with minimal weakness) may have important functional value.

SPINAL SPASTICITY - list of disorders in which ITB has been beneficial

• Multiple Sclerosis
• Spinal Cord injury
• Spinal Ischemia
• Transverse Myelitis
• Spinal Cord Tumor
• Compressive Myelopathy
• Stiff Man Syndrome
• Dystonia (Cerebral)
• Primary Lateral Sclerosis
• Hereditary Spasticity
• Anoxia

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Spasticity of Cerebral Origin

• Severe spasticity of cerebral origin - defined as >3 (Ashworth) - legs
• Previous oral antispasmodics not required
• 3 years of age or older, with enough body mass to support SynchroMed Infusion System
• Minimun of 1 year post-trauma for brain injury
• Brain injury occurred before age 2 for cerebral palsy

(entry criteria for treatment IND program)

Cerebral Origin Spasticity: Special Considerations:

Candidates/Selection Criteria

STEP 4: Screening Trial

Does the patient respond to the trial bolus of ITB therapy?
If the patient responds: proceed with implant -- if the patient desires.
If the patient does not respond: do not proceed.

Pie graph: implantation to no implantation ratio: after experiencing intrathecal baclofen trial