Medtronic
 
 

ITB TherapySM

Clinical Evidence in Spastic Hypertonia
Associated with Spinal Cord Injury

Guillaume D, Van Havenbergh A, Vloeberghs M, Vidal J, Roeste G. A clinical study of intrathecal baclofen using a programmable pump for intractable spasticity. Arch Phys Med Rehabil. 2005;86(11):2165- 2171.

Methods
  • 138 patients with severe spasticity of cerebral or spinal origin; 129 were implanted (36 had SCI)
  • Non-comparative, multicenter, prospective cohort trial
  • Follow-up at 3, 6, 9, and 12 months
  • Patient age range: 4 to 74
Results
  • For patients with spasticity of spinal origin, Ashworth scores decreased:
    • In lower extremities from 3.68 ± 0.81 to 1.92 ± 0.75 (p < 0.001)
    • In upper extremities from 1.65 ± 0.78 to 1.34 ± 0.50 (p < 0.001)
  • Significant decreases in spasm scores from baseline to 12 months from 2.70 ± 1.24 to 0.97 ± 0.95 (p < 0.001)
  • Improvement in motor function was observed at 12 months (p < 0.001) and in cognitive function at 3 months (p = 0.01) 
  • Performance and satisfaction in selected occupational tasks as measured by the COPM showed improvement (p < 0.001)
  • 87% of physicians rated their overall satisfaction as good or very good, 8% fair, and 5% poor or very poor
  • 10% of patients experienced surgery-related adverse events, including cerebrospinal fluid leak (1), catheter dislodgement during surgery (1), spinal headache (1), drug adverse effect (1), meningitis (1), leg pain (1), hematoma (2), incontinence (2) and pocket wound infection (3)
  • 9% of patients experienced catheter related events, including catheter dislodgement (4), catheter kink (3), catheter occlusion (1), pocket seroma (1), underinfusion (1), and spinal headache (1)
  • 43% of the patients who underwent pump implantation reported at least 1 adverse event during the 12 months of follow-up
  • 5 patient deaths occurred and were unrelated to ITB Therapy

Ordia JI, Fischer E, Adamski E, Chagnon KG, Spatz EL. Continuous intrathecal baclofen infusion by a programmable pump in 131 consecutive patients with severe spasticity of spinal origin. Neuromod. 2002;5(1):16-24.

Methods
  • N = 152 patients with severe spasticity of spinal origin; 131 implanted (53 of those implanted had SCI)
  • All failed to respond to oral anti-spasmodic medications, became refractory to medical treatments or developed intolerable side effects
  • Double-blind, randomized placebo control trial for the first 9 patients
  • Follow-up period 2 to 137 months (mean 73 months)
  • Patient age range: 17 to 73
Results
  • Pre-op to post-op mean Ashworth score: 4.2 to 1.3 (p < 0.0005)
  • Pre-op to post-op mean Spasm score: 3.4 to 0.6 (p < 0.0005)
  • 18 ambulatory patients had improvement in their gait and balance, and 2 previously non-ambulatory patients were able to walk
  • Pre-op and post-op urodynamic studies in 8 patients demonstrated reduced detrusor hypereflexia and bladder-sphincter dyssynergy and increased bladder capacity
  • 10 patients developed a spinal-type headache following the screening test, 6 developed a spinal headache post-surgery, 12 patients had worsened constipation, and 7 patients experienced hypotonia
  • 24 catheter problems occurred in 19 patients, 12 occlusions and kinks, 8 breaks
  • 1 patient developed bacterial meningitis
  • 10 patients died during follow-up, none of which were attributable to ITB Therapy

Dario A, Scamoni C, Bono G, Ghezzi A, Zaffaroni M. Functional improvement in patients with severe spinal spasticity treated with chronic intrathecal baclofen infusion. Funct Neurol. 2001;16(4):311- 315.

Methods
  • 20 non-ambulatory patients with severe spasticity of spinal origin (7 with spinal cord injury or disease)
  • All unresponsive to medical therapy
  • Retrospective study
  • Follow-up period 12 to 36 months (mean 22.4 months)
  • Patient age range: 27 to 52
Results
  • Ashworth scores decreased from 4.4 ± 0.5 to 1.8 ± 0.7 (p < 0.01)
  • Spasm Frequency Scale (in 13 patients) decreased from 2.5 ± 0.8 to 0.5 ± 0.4 (p < 0.01)
  • Self-reported pain scores decreased from 2.5 ± 2.2 to 2.3 ± 1.9 (p < 0.05)
  • Statistically significant improvements in Functional Independence Measure scores:
    • Increase from mean of 33.8 ± 6.9 to 58.7 ± 10.4 (p < 0.05)
    • Improvements mainly in bathing, dressing lower body, and transfers
    • FIM score improvements in patients with tetraparesis was only slight
  • No drug-related adverse events were reported
  • 1 patient experienced CSF leak around the catheter, which required surgical repair

Ordia JI, Fischer E, Adamski E, Spatz EL. Chronic intrathecal delivery of baclofen by a programmable pump for the treatment of severe spasticity. J Neurosurg. 1996;85(3):452-457.

Methods
  • N = 66 with severe spasticity of spinal origin, 59 implanted (27 of those implanted had SCI)
  • Medical treatment failed in all patients
  • Follow up period 23 to 70 months (mean 42 months)
  • Patient age range: 16 to 73
Results
  • All responded positively to the bolus (screening) dose of ITB Therapy
  • Mean Ashworth score decreased from 4.3 preoperatively to 1.4 at last follow-up (p < 0.0005)
  • Spasm score decreased from 3.6 to 0.5 (p < 0.0005)
  • Several patients found that activities of daily living such as transferring from wheelchair to bed were easier to accomplish
  • Muscle aches and pain, sleeplessness, and overall misery associated with uncontrolled spasms were considerably improved
  • Reduction in average length of hospitalization during the first year after the pump was implanted, but no change in overall utilization of outpatient resources
  • Net reduction in hospital days was 27 for an average reduction of 2.7 days per patient
  • 6 patients with preexisting constipation were more symptomatic post-surgery; all responded to a bowel regimen. 3 ambulatory patients experienced muscular hypotonia. 3 patients experienced urinary retention
  • Catheter-related problems occurred 19 times in 15 patients, including 7 breaks in 5 patients, 9 occlusions, 2 punctures, and 1 dislodgement
  • 2 pumps were explanted, 1 due to infection in the pump pocket, and 1 was removed due to skin erosion
  • 2 patient deaths occurred, neither related to ITB Therapy

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.

Methods
  • N = 93 adults with severe spasticity of spinal origin; 75 implanted (47 of those implanted had SCI)
  • Randomized, double-blind, placebo-controlled screening protocol
  • Long-term, multicenter study
  • Follow-up period 5 to 41 months (mean 19 months)
  • Patient age range: 19 to 69
Results
  • Decrease in Ashworth (AS) scores (pre-op to post-op mean AS: 3.9 to 1.7)
    • No significant difference between patients with MS versus SCI
  • Decrease in Spasm (SS) scores (pre-op to post-op mean SS: 3.1 to 1.0)
    • No significant difference between patients with MS versus SCI
  • 11 patients experienced drug related complications including hypotension, seizure, and depression; 6 patients developed an episode of suspected tolerance
  • 22 catheter malfunctions in 18 patients (dislodgement, kink, disconnect, and occlusion)
  • 3 deaths of unknown cause
  • 3 mechanical failures required removal and pump replacement

Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years experience. J Neurosurg. 1992;77(2):236-240.

Methods
  • N = 66 patients with severe spasticity and/or spasms of spinal origin; 62 implanted (30 of those implanted had spinal trauma)
  • All failed oral anti-spasmodic drug therapy
  • Follow-up period averaged 30 months
  • Patient age range: 10 to 71
Results
  • 64/66 (97%) patients screened responded with a reduction in Ashworth scale and/or spasm scale scores of 2 points or more
  • 3 patients had recurrence of spasms or rigidity after 2, 3, and 3.5 years of successful management in spite of verified drug delivery to the lumbar space
  • Therapy well-tolerated
    • Transient side effects reported in 31 patients; most common side effects were drowsiness (22), dizziness (10), blurred vision (10), and slurred speech (6); side effects were managed with dose adjustments
  • 25 catheter malfunctions
  • Pump failed in 7% of cases resulting in cessation of baclofen delivery
  • 5 procedural complications occurred
  • 4 patient deaths were unrelated to ITB Therapy

ITB Therapy (Intrathecal Baclofen Therapy) is indicated for use in the management of severe spasticity. For spasticity of spinal cord origin, ITB Therapy via an implantable infusion system should be reserved for patients unresponsive to oral baclofen or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long-term intrathecal baclofen therapy.

Important Safety Information for ITB Therapy:
Intrathecal Baclofen Withdrawal: Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at risk (e.g., spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen).

This therapy is contraindicated in patients who are hypersensitive to baclofen. Implantation of the infusion system is contraindicated if the patient is of insufficient body size, requires a pump implant deeper than 2.5 cm, or, in the presence of spinal anomalies or active infection.

The most frequent drug adverse events vary by indication but include: hypotonia (34.7%), somnolence (20.9%), headache (10.7%), convulsion (10.0%), dizziness (8.0%), urinary retention (8.0%), nausea (7.3%), and paresthesia (6.7%). Pump system component failures leading to pump stall, or dosing/programming errors may result in clinically significant overdose or underdose. Acute massive overdose may result in coma and may be life threatening.

The most frequent and serious adverse events related to device and implant procedures are catheter dislodgement from the intrathecal space, catheter break/cut, and implant site infection including meningitis. Electromagnetic interference (EMI) and Magnetic resonance imaging (MRI) may cause patient injury, system damage, operational changes to the pump, and changes in flow rate.

Please refer to the full prescribing information and system information for details or call Medtronic at 1-800-328-0810. Rx Only. Lioresal® is a registered trademark of Novartis Pharmaceuticals Corporation.

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