Medtronic
 
 

ITB TherapySM

Clinical Evidence in Spastic
Hypertonia Associated with Brain 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; 10 had traumatic brain injury; 129 were implanted
  • 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 cerebral origin spasticity, Ashworth scores decreased:
    • In lower extremities from 4.02 ± 0.92 to 1.96 ± 0.78 (p < 0.001)
    • In upper extremities from 3.58 ± 1.25 to 2.07 ± 0.86 (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

Gooch JL, Oberg WA, Grams B, Ward LA, Walker ML. Care provider assessment of intrathecal baclofen in children. Dev Med Child Neurol. 2004;46(8):548-552.

Methods
  • N = 80 (10 had traumatic brain injury with severe spasticity of cerebral origin)
  • Case series of consecutive patients
  • Receiving ITB Therapy for a minimum of 1 year at time of evaluation
  • Patient age range: almost 4 to 21
Results
  • Tone reduction of 0 to 0.9 in upper and of 1.0 to 1.9 in lower extremities as measured by Ashworth Scale
  • 84% (43/51) experienced no loss of range of motion; 16% (8/51) experienced some loss of range of motion
  • Patients who chose the following goals showed these improvements:
    • 91% prevented worsening of deformity
    • 91% experienced improvement in ability to assist with daily living skills
    • 88% experienced improvement in ease of care
  • 81% strongly agreed they would have the procedure performed again; 14% slightly agreed
  • All care providers reported improvement scores in the Caregiver Questionnaire
  • Non-system related complications included cognitive status change (2), severe spasms (1), and overdose (1)
  • A total of 70 device-related complications requiring surgery occurred in 63 patients. The most common in this study were catheter occlusion/angulation (12), dislodgement (12), and disconnection at the pump (11), catheter tear/separation (9), and pump pocket infection with removal (8)
  • The chance of requiring a repeat surgery due to complications was 19%
  • The most common system-related complications not requiring surgery included CSF leak, flipped pump, and suture site inflammation
  • 4 patients died of causes unrelated to the pump

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 = 8, all with severe spasticity related to traumatic brain injury (TBI)
  • All patients previously failed physical therapy and oral anti-spasmodic medications
  • Prospective, single-center study
  • Follow up 17 to 81 months
  • Patient age range: 20 to 72
Results
  • Statistically significant reduction in lower extremity (LE) and upper extremity (UE) spasticity
    • LE: Ashworth score decreased from 4.4 to 1.3 (p < 0.05)
    • UE: Ashworth score decreased from 2.7 to 1.5 (p < 0.05)
  • Locomotion was easier for 3 previously ambulatory patients
  • 1 previously non-ambulatory patient could ambulate with the use of a walker
  • Drug-related adverse events included 2 patients that had muscular hypotonia, 1 patient that had erythema of the skin over the pump pocket, and 1 patient that had an areflexic bladder
  • Device complications included 1 pump that was explanted after it eroded through the skin
  • There were no catheter-related problems or pump failures
  • 1 death occurred unrelated to ITB Therapy

Becker R, Alberti O, Bauer BL. Continuous intrathecal baclofen infusion in severe spasticity after traumatic or hypoxic brain injury. J Neurol. 1997;244(3):160-166.

Methods
  • N = 18, all with severe spasticity due to traumatic or hypoxic brain injury
  • Prospective, single-center study
  • Patient age range: 25 to 70
Results
  • Ashworth score decreased from 4.5 to 2.33
  • Spasm frequency score decreased from 2.16 to 0.94
  • All patients achieved therapeutic goals to ease care and physical therapy as well as reduce spasticity-related pain
  • Transfer to wheelchairs was easier and patients were able to sit in them longer
  • Of the 12 bedridden patients, at least 8 could be temporarily mobilized in wheelchairs; mobilization in bed was possible for the first time for 3 patients; mobilization was unchanged in 1 patient
  • 6 patients were already partially mobilized before ITB Therapy, 3 improved further, 1 was unchanged, and 2 were unassessed   
  • In 5 of 11 patients, decubital ulcers healed completely during the course of treatment and in 5 more the ulcers improved
  • 1 patient experienced a seizure following the screening test
  • 1 infection in the pump pocket led to the removal of the system; 1 catheter dislodgement

Meythaler JM, McCary A, Hadley MN. Prospective assessment of continuous intrathecal infusion of baclofen for spasticity caused by acquired brain injury: a preliminary report. J Neurosurg. 1997;87 (3):415-419.

Methods
  • N = 12, all with acquired brain injury
  • Patients screened via randomized, double-blind, placebo-controlled crossover evaluation
  • Severe spasticity refractory to maximum medical therapy that interfered with patients’ activities of daily living
  • Patient age range: 17 to 39
Results
  • Lower extremities:
    • Ashworth scale decreased from 3.5 ± 1.2 to 2.2 ± 0.9 at 3 months (p < 0.0001, Wilcoxon signed-rank test)
    • Spasms Frequency scale decreased from 1.8 ± 1.2 to 0.2 ± 0.5 at 3 months (p < 0.0001, Wilcoxon signed-rank test)
    • Reflex score decreased from 2.7 ± 1 to 0.2 ± 0.6 at 3 months (p < 0.0001, Wilcoxon signed-rank test)
  • Upper extremities:
    • Ashworth scale decreased from 3.3 ± 1.3 to 1.9 ± 0.8 at 3 months (p = 0.0033, Wilcoxon signed-rank test)
    • Spasms Frequency scale decreased from 1.8 ± 1.3 to 0.6 ± 1.0 at 3 months (p = 0.0070, Wilcoxon signed-rank test)
    • Reflex score decreased from 2.7 ± 0.5 to 1.7 ± 0.6 at 3 months (p = 0.0111, Wilcoxon signed-rank test)
  • 5 of the 11 patients experienced functional improvements in gait and transfers
  • 2 patients progressed from being dependent in gait to independent walking with supportive devices
  • Noted reductions in joint contractures in 7 patients
  • 5 patients had spinal headaches lasting 1 week post-implant; 3 patients had postoperative atelectasis
  • 1 patient had catheter dislodgement caused by “twiddler's syndrome”
  • No drug-related adverse events were reported 

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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