Intrathecal baclofen for spastic hypertonia from stroke

Background and Purpose-We sought to determine whether continuous intrathecal delivery of baclofen can effectively decrease spastic hypertonia due to stroke. Methods-Stroke patients with >6 months of intractable spasticity were screened via a randomized, double-blind, placebo-controlled crossover design of either intrathecal normal saline or 50 mug baclofen. Those who dropped an average of 2 points in either their affected lower extremity side Ashworth or Penn spasm frequency scores were then offered computer-controlled pump implantation for continuous ITB and followed prospectively for up to 12 months. Results-In 21 stroke patients 6 hours after the active drug bolus, the average (+/- SD) lower extremity Ashworth score on the affected extremities decreased from 3.3 +/- 1.2 to 1.4 +/- 0.7 (P < 0.0001), spasm score from 1.2 1.2 to 0.1 +/- 0.3 (P = 0.0224), and reflex score from 2.1 +/- 1.2 to 0.1 +/- 0.5 (P < 0.0001). The average upper extremity Ashworth score on the affected extremities decreased from 2.8 1.1 to 1.8 +/- 0.8 (P < 0.0001), spasm score from 0.7 1.0 to 0.2 +/- 0.4 (P = 0.1544), and reflex score from 2.1 +/- 0.9 to 1.2 +/- 0.9 (P = 0.0004). All active drug scores were statistically different from placebo scores at 6 hours (P < 0.05). With up to 12 months of continuous infusion of ITB in 17 implanted patients, the average lower extremity Ashworth score on the affected extremities decreased from 3.7 1.0 to 1.8 +/- 1.1 (P < 0.0001), the spasm score dropped from 1.2 1.3 to 0.6 +/- 1.0 (P = 0.4282), and the reflex score decreased from 2.4 +/- 1.3 to 1.0 +/- 1.3 (P < 0.0001). The average upper extremity Ashworth score in the affected extremities decreased from 3.2 1.1 to 1.8 +/- 0.9 (P < 0.0001), the spasm score dropped from 0.7 1.0 to 0.3 +/- 0.8 (P = 0.8685), and the reflex score decreased from 2.4 +/- 0.8 to 1.5 +/- 1.2 (P = 0.3337). The average continuous ITB dose required to attain these effects was 268 mug/d. Conclusions-Intrathecal infusion of baclofen is capable of maintaining a reduction in the spastic hypertonia resulting from stroke.