• NeuroRehabilitation · Jan 2014

    High doses of a new botulinum toxin type A (NT-201) in adult patients with severe spasticity following brain injury and cerebral palsy.

    • Domenico Intiso, Valentina Simone, Filomena Di Rienzo, Andrea Iarossi, Luigi Pazienza, Andrea Santamato, Giuseppe Maruzzi, and Mario Basciani.
    • Neuro-Rehabilitation Unit, Scientific Institute, Hospital 'Casa Sollievo della Sofferenza', San Giovanni Rotondo (Foggia), Italy.
    • NeuroRehabilitation. 2014 Jan 1; 34 (3): 515-22.

    BackgroundSpasticity can be a severe disabling disorder requiring high-dose injections of botulinum toxin type A (BoNT-A). Efficacy and safety of high BoNT-A doses in reducing multi-level spasticity of subjects with brain injury and cerebral palsy were investigated. Pain and functional outcome were also assessed.MethodHigh doses (up to 840 IU) of incobotulinumtoxinA were injected in adult subjects with severe spasticity of the upper and lower limbs due to brain injury (BI) and cerebral palsy (CP). The Modified Ashworth Scale, Visual Analogue scale, Glasgow Outcome Scale, Franchay Arm Test (FAT) and Barthel Scale were employed to assess spasticity, pain and functional outcome at baseline, and 4 and 16 weeks after BoNT-A injection.ResultsTwenty-two (12 M, 10 F; mean age 38.1 ± 13.7 years) subjects - 16 subjects with BI and 6 with CP - were enrolled. Elbow, wrist, fingers and ankle muscles showed significant spasticity reduction after BoNT-A injections. The mean FAT score improved, but the benefit was not significant. Three (13.6%) subjects complained of mild adverse events.ConclusionHigh-dose BoNT-A injections were effective and safe in reducing spasticity of BI and CP subjects. A significant reduction of the pain was also observed, but global functionality and arm dexterity were unchanged.

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