1. Intrathecal baclofen Troubleshooting and Management
Michael Saulino, MD PhD
MossRehab
Assistant Professor
Thomas Jefferson University
Adjuvant Assistant Professor
Temple University

2. CME Disclosures 1 Speaker’s bureau for Jazz Pharmaceuticals
Speaker’s bureau and clinical investigator for Medtronic, Inc
Speaker’s bureau for Ipsen
Consultant for SPR therapeutics and Myoscience

3. CME Disclosures 2
Will discuss off label and investigational indications for medications and devices
All activities are reviewed by Albert Einstein Healthcare Network’s conflict of interest committee
Honoraria are paid directly to PMR department

4. Intrathecal baclofen therapy
Consider all factors to optimize therapy
Patient
Disease
Agent
Device
Clinician

5. Patients
Given the divergence of disease conditions and presentations that be affected by ITB, it is crucial that clinicians counsel patients carefully regarding their expectations for this therapy
Patients should be queried about their individual goals for treatment.
They may indentify a wide variety of aspirations, anything from reduced caregiver burden to improved ambulatory capacity.

6. Patient factors Might be a problem with language
“Spasms” and “Stiffness” can have multiple meanings
Pain ≠ spasticity 6

7. Disease factors Varieties of increased resistance to PROM
Spasticity  ITB approved
Dystonia  ITB sensitive
Contracture  not ITB sensitive
Heterotopic ossification
Ankylosis
Rigidity
Gegenhalten / paratonia

8. Diseases (approved indications)
Spinal cord injury
Multiple sclerosis
Cerebral palsy
Stroke
Traumatic brain injury

9. Other illnesses potentially sensitive to ITB
Non-traumatic spinal diseases: hereditary spastic paraparesis, transverse myelitis, ALS
Dystonias
Metabolic disorders: adrenoleukodystrophy
Primary muscle diseases: tetanus, stiff person syndrome

10. Noxious stimuli Can increase or drive increase tone
In a previously stable patient, increased tone can be the harbinger of a secondary influence
Searching for this driving force can be a daunting task

11. Potential Noxious Stimuli
Urinary: infection, stones, distention
Dermatological: decubuti, surgical incisions
Neurological: hydrocephalus, syringomyelia
Pulmonary: pneumonia, coughing
Medications: SSRIs
Unusual: sunburn, bee stings, cancer

12. Agent Traditionally, effects of ITB have been related to two factors:
Catheter tip location
Dosage administered
Emerging data suggests that drug concentration / volume administered / flow rate can play a role in therapeutic effects.

13. Agent Does tolerance to ITB exist ?
Reported as high as 30 % in the literature, although thorough investigation into other potential causes can be lacking
Potentially addressed by bolus delivery or variable / complex dosing regimens

14. Catheter Micro-fractures
Dawes WJ, Drake JM, Fehlings D. Pediatr Neurosurg Sep;39(3):144-8. 14

15. Agents Intrathecal Lioresal – FDA approved – Medtronic / Novartis
Intrathecal Gablofen – FDA approved – CNS therapeutics
Compounded baclofen – not FDA approved – state regulated, compounding pharmacies

16. Investigation Techniques for Catheter Problems
Plain radiography Catheter dye study CT myelogram Nuclear medicine cisternogram Magnetic resonance imaging 16

17. Device factors Pump Catheter
Potential problems: pocket fill, battery failure, empty reservoir, programming errors, motor stall
Catheter
Potential problems: kinks, holes, blockages 17

18. CT myelogram after side port injection
Remove 2-3 mls of fluid
Inject 2-3 mls of isotonic contrast
Patient is then immediately spiral scanned from 2 vertebral segments above the tip of the catheter, down through the pump in the abdomen. 18

19. CT myelogram dye study Advantages: Disadvantages:
Improved sensitivity compared to plain films and fluoroscopy
“Free” CT of abdomen, thorax, lumbar and thoracic spine
Disadvantages:
Technical expertise
Coordination with radiology
Cannot undertake if fluid cannot be aspirated from side port

20. Normal study 20

21. Contrast loculated in the spinal canal21

22. Contrast ventral to CSF suggesting subdural migration22

23. Contrast extravasating into the subcutaneous tissues suggesting catheter breakage23

24. Contrast filing of an intrathecal granuloma

25. Clinicians
Manager
Evaluator
Trialist
Implanter
Trouble
shooter

26. Intrathecal baclofen therapy
Consider all factors to optimize therapy
Patient
Disease
Agent
Device
Clinician