Clinical Evidence in Spastic Hypertonia Associated with Stroke

Ivanhoe CB, Francisco GE, McGuire JR, Subramanian T, Grissom SP. Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life. Arch Phys Med Rehabil. 2006;87(11):1509-1515.

Methods

• N = 94 (74 received ITB Therapy; 57 with 12-month follow up)
• Prospective, open-label, multicenter trial
• Follow-up at 3 and 12 months  
• Patient age range: 24 to 82

Results

• Significant decrease in spastic hypertonia in upper and lower limbs (combined average Ashworth Scale scores) at 3 months (p < 0.001) and 12 months (p < 0.001)
• Significant improvement in function at 3 months (p = 0.001) and 12 months (p = 0.017), as indicated by FIM scores
• Significant improvement in quality of life at 3 months (p = 0.003) and 12 months (p < 0.001), as indicated by SIP scores
• Muscle strength in the unaffected limbs did not change overall at either 3 months (p = 0.553) or 12 months (p = 0.462), as measured by the Manual Muscle Test (MMT)
• 50 participants reported 123 adverse events; the most common drug-related adverse events were accidental injury, somnolence, dizziness, and hypotonia
• 43 reports of system complications in 27 participants; the most common were spinal headache, CSF leak, and catheter complications
• 3 deaths occurred but were related to neither drug nor device

Schiess M, Stimming Furr E, Fisher S, Acosta F, Simpson R, Izor R. Functional motor improvement in stroke related spastic hemiparesis after intrathecal baclofen pump therapy. Neurology. 2006;66.

Methods

• N = 21
• Minimum 6 months duration stroke, who failed oral antispasmodic therapy
• Data points collected preoperatively, post-implantation at 3, 6, and 12 months
• Patient age range: 27 to 75

Results

• Significant decrease in Modified Ashworth scores in arm (29%, p < 0.00006) and leg (33%, p < 0.000004)
• Significant increase in arm (70%, p < 0.005) and leg (67%, p < 0.00001) muscle testing as measured by MMT
• Improvement in using affected arm (p < 0.05) and how well the arm is used (p < 0.00007) as measured by UE/MAL
• Mean increase in modified independence measure (FIM) (p < 0.05)
• Significant improvement in 11 of 12 domains in Stroke Specific Quality of Life Scale (p < 0.05)
• Increase in gait velocity of 60% m/sec
• No drug-related adverse events or system complications were reported in this abstract

Francisco GE, Boake C. Improvement in walking speed in poststroke spastic hemiplegia after intrathecal baclofen therapy: a preliminary study. Arch Phys Med Rehabil. 2003;84(8):1194-1199.

Methods

• N = 10
• Stroke patients with severe spasticity; all were ambulatory prior to ITB Therapy
• Case series
• Inadequate spasticity control with other pharmacologic and physical modalities
• Patient age range: 31 to 69

Results

• Improvement in walking speed from baseline was 15.4 ± 14.4 cm/second (p = 0.0051)
• The functional mobility mean increase was 2.7 ± 2.9 (p = 0.0277)
• Modified Ashworth score mean reduction in lower-extremities was 1.6 ± 0.5 (p = 0.0051)
• All participants showed normal muscle strength in the unaffected lower extremity at follow-up
• 2 patients experienced headache, nausea, vomiting, excessive weakness, and transient urinary retention

Meythaler JM, Guin-Refroe S, Brunner, RC, Hadley MN. Intrathecal baclofen for spastic hypertonia from stroke. Stroke. 2001;32(9):2099-2109.

Methods

• N  =  21; 17 had 12-month follow up
• Stroke patients with  >  6 months of severe spasticity
• Randomized, double-blind, placebo-controlled crossover design bolus trial followed prospectively for 12 months
• All had failed oral medications due to lack of efficacy or intolerable side effects
• Patient age range: 16 to 86

Results

• 6 hours after active-drug bolus, average Ashworth (5-point) scores dropped significantly (p  <  0.05 compared to placebo) in stroke-affected extremities:
• Lower extremities : 3.3 ± 1.2 to 1.4 ± 0.7 (p < 0.0001, Friedman Test)
• Upper extremities : 2.8 ± 1.1 to 1.8 ± 0.8 (p < 0.0001, Friedman Test)
• Significant change in average Ashworth (5-point) scores in stroke-affected extremities at 12 months
• Lower extremities: 3.7 ± 1.0 to 1.8 ± 1.1 (p < 0.0001, Friedman Test)
• Upper extremities: 3.2 ± 1.1 to 1.8 ± 0.9 (p < 0.0001, Friedman Test)
• No objective or subjective motor weakness noted on unaffected side
• 3 patients went from wheelchair dependence to independent ambulation with assistive devices
• All dependent patients were more comfortable and were easier to manage at home with regard to hygiene, ADL, and assisted transfers
• No patient developed seizures after pump implant, nor was there a history of seizures in any of these patients prior to pump placement
• There were no complications related to the short-term discontinuance of coumadin for either the bolus trial or the pump placement
• 5 patients had urinary retention following initial pump placement. The dose was reduced in these patients and symptoms did not return, even when doses were increased over time
• Several patients experienced postoperative headache and nausea, but the symptoms were transient

©Medtronic, Inc. 2008                                                   • Contact Medtronic • Privacy Statement • Terms of Use • Site Map