Intrathecal Baclofen Management of Poststroke Spastic Hypertonia: Implications for Function and Quality of Life

Ivanhoe CB, Francisco GE, McGuire JR, Subramanian T, Grissom SP. Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life.ObjectivesTo evaluate the impact of intrathecal baclofen (ITB) on function and quality of life (QOL) and to obtain efficacy and safety data in poststroke spastic hypertonia.DesignProspective open-label multicenter trial with follow-up at 3 and 12 months.SettingTwenty-four stroke treatment centers in the United States.ParticipantsNinety-four stroke participants (age range, 24−82y) with spastic hypertonia. Seventy-four participants underwent ITB pump implantation.InterventionParticipants were implanted with an ITB pump.Main Outcome MeasuresFIM instrument and QOL (Sickness Impact Profile [SIP]) changes, spastic hypertonia (Ashworth Scale), and safety.ResultsFIM scores improved overall in repeated-measures analysis of variance (ANOVA) (P=.005) and by 3.00±7.69 (P=.001) at 3 months and by 2.86±10.13 (P=.017) at 12 months. Significant improvements in SIP scores were noted overall (repeated-measures ANOVA, P<.001) and at 3 (P=.003) and 12 months (P<.001). The combined average Ashworth Scale score of the upper and lower limbs decreased by 1.27±0.76 (P<.001) at 3 months and by 1.39±0.73 (P<.001) at 12 months from baseline, which was significant overall (repeated-measures ANOVA, P<.001). Strength in the unaffected side did not change overall (repeated-measures ANOVA, P=.321) or at either 3 (P=.553) or 12 months (P=.462). Minimal adverse events and device complications were reported.ConclusionsThere was significant improvement in function, QOL, and spastic hypertonia at 3 and 12 months after implant, without adversely affecting muscle strength of the unaffected limbs. Data suggest that ITB therapy is a safe and efficacious treatment for spastic hypertonia resulting from stroke.