Clinical efficacy of botulinum toxin type A in patients with traumatic brain injury, spinal cord injury, or multiple sclerosis: An observational longitudinal study

Alessio Baricich; Marco Battaglia; Daria Cuneo; Lucia Cosenza; Marzia Millevolte; Michela Cosma; Mirko Filippetti; Stefania Dalise; Valentina Azzollini; Carmelo Chisari; Stefania Spina; Nicoletta Cinone; Lorenza Scotti; Marco Invernizzi; Stefano Paolucci; Alessandro Picelli; Andrea Santamato

doi:10.3389/fneur.2023.1133390

Clinical efficacy of botulinum toxin type A in patients with traumatic brain injury, spinal cord injury, or multiple sclerosis: An observational longitudinal study

Front Neurol. 2023 Apr 6:14:1133390. doi: 10.3389/fneur.2023.1133390. eCollection 2023.

Authors

Alessio Baricich^{1

2}, Marco Battaglia^{1

2}, Daria Cuneo³, Lucia Cosenza⁴, Marzia Millevolte⁵, Michela Cosma⁶, Mirko Filippetti⁷, Stefania Dalise⁸, Valentina Azzollini⁸, Carmelo Chisari⁸, Stefania Spina⁹, Nicoletta Cinone⁹, Lorenza Scotti¹⁰, Marco Invernizzi^{1

11}, Stefano Paolucci¹², Alessandro Picelli⁷, Andrea Santamato⁹

Affiliations

¹ Physical and Rehabilitation Medicine, Department of Health Sciences, Università del Piemonte Orientale, Novara, Italy.
² Physical and Rehabilitation Medicine, "Ospedale Maggiore della Carità" University Hospital, Novara, Italy.
³ Physical and Rehabilitation Medicine, A.S.L. Vercelli, Vercelli, Italy.
⁴ Rehabilitation Unit, Department of Rehabilitation, "Santi Antonio e Biagio e Cesare Arrigo" National Hospital, Alessandria, Italy.
⁵ Neurorehabilitation Clinic, Department Neurological Sciences, University Hospital of Ancona, Ancona, Italy.
⁶ Neuroscience and Rehabilitation Department, Ferrara University Hospital, Ferrara, Italy.
⁷ Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.
⁸ Neurorehabilitation Section, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
⁹ Spasticity and Movement Disorder Unit, Physical Medicine and Rehabilitation, Policlinico Riuniti, University of Foggia, Foggia, Italy.
¹⁰ Department of Translational Medicine, Unit of Medical Statistics, Università del Piemonte Orientale, Novara, Italy.
¹¹ Dipartimento Attività Integrate Ricerca e Innovazione (DAIRI), Translational Medicine, "Santi Antonio e Biagio e Cesare Arrigo" National Hospital, Alessandria, Italy.
¹² IRCCS Fondazione Santa Lucia, Rome, Italy.

Abstract

Botulinum toxin type A (BoNT-A) is the treatment of choice for focal spasticity, with a concomitant effect on pain reduction and improvement of quality of life (QoL). Current evidence of its efficacy is based mainly on post stroke spasticity. This study aims to clarify the role of BoNT-A in the context of non-stroke spasticity (NSS). We enrolled 86 patients affected by multiple sclerosis, spinal cord injury, and traumatic brain injury with clinical indication to perform BoNT-A treatment. Subjects were evaluated before injection and after 1, 3, and 6 months. At every visit, spasticity severity using the modified Ashworth scale, pain using the numeric rating scale, QoL using the Euro Qol Group EQ-5D-5L, and the perceived treatment effect using the Global Assessment of Efficacy scale were recorded. In our population BoNT-A demonstrated to have a significant effect in improving all the outcome variables, with different effect persistence over time in relation to the diagnosis and the number of treated sites. Our results support BoNT-A as a modifier of the disability condition and suggest its implementation in the treatment of NSS, delivering a possible starting point to generate diagnosis-specific follow-up programs.

Clinical trial identifier: NCT04673240.

Keywords: botulinum toxin; movement disorders; multiple sclerosis; pain; rehabilitation; spasticity; spinal cord injury; traumatic brain injury.

Associated data

ClinicalTrials.gov/NCT04673240

Grants and funding

This research was funded under a grant from Ipsen and on behalf of the Spasticity Management Group of Italian Society of Neurological Rehabilitation (SIRN). Ipsen had no input into the study design, analysis, or interpretation of results.