Safety and efficacy of abobotulinumtoxinA for hemiparesis in adults with upper limb spasticity after stroke or traumatic brain injury: a double-blind randomised controlled trial

Graciès, Jean-Michel; Brashear, Allison; Jech, Robert; McAllister, Peter; Banach, Marta; Valkovič, Peter; Walker, Heather W.; Marciniak, Christina; Deltombe, Thierry; Скоромец, А А; Khatkova, Svetlana; Edgley, Steven R.; Gül, Fatma; Fer, Béatrice Bois De; Vilain, Claire; Picaut, Philippe

doi:10.1016/s1474-4422(15)00216-1

Cited by 175 publications

(207 citation statements)

References 32 publications

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“…Botulinum toxin is routinely used to treat focal spastic hypertonia in various upper motor neuron disorders (Esquenazi et al., 2013; Simpson et al., 1996). Indeed, peripheral injection of botulinum toxin type A (BoNT‐A) is one available treatment for focal problematic spastic hypertonia and associated pain, and it is particularly effective on upper limb spasticity in the subacute phase after stroke (Gracies et al., 2015; Slawek, Bogucki, & Reclawowicz, 2005). Physiotherapy in the subacute phase can further prolong the positive effect induced by botulinum toxin injection (Han, Wang, Meng, & Qi, 2013; Kinnear, Lannin, Cusick, Harvey, & Rawicki, 2014).…”

Section: Introductionmentioning

confidence: 99%

Botulinum toxin A modifies nociceptive withdrawal reflex in subacute stroke patients

Alvisi

Serrao²,

Conte

et al. 2018

Brain and Behavior

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ObjectivesThe aims of this study were to evaluate the pattern of the nociceptive withdrawal reflex (NWR) of the upper limb at rest and after injection of Botulinum toxin type A (BoNT‐A) in poststroke subacute hemiparetic patients.MethodsFourteen patients with poststroke subacute hemiparesis underwent clinical and instrumental evaluation and BoNT‐A injection. Painful electrical stimulation was applied to induce the NWR. Baseline EMG activity and NWR recordings (EMG and kinematic response) were performed at T0, one month (T1), and three months (T2) after the BoNT‐A injection, as were Modified Ashworth Scale (MAS) and Functional Independence Measure (FIM) scores.ResultsComparison of results at T0, T1, and T2 revealed significant changes in the MAS score for the elbow (p < 0.001) and wrist joints (p < 0.001) and in the FIM score at T0 and T2. BoNT‐A injection had a significant effect on both NWR amplitude and baseline EMG activity in the posterior deltoid (PD) and flexor carpi radialis (FCR) muscles as well as in all averaged muscles. Analysis of elbow kinematics before and after treatment revealed that the reflex probability rates were significantly higher at T1 and T2 than at T0.ConclusionInjection of BoNT‐A in the subacute phase of stroke can modify both the baseline EMG activity and the NWR‐related EMG responses in the upper limb muscles irrespective of the site of injection; furthermore, the reflex‐mediated defensive mechanical responses, that is, shoulder extension and abduction and elbow flexion, increased after treatment. BoNT‐A injection may be a useful treatment in poststroke spasticity with a potential indirect effect on spinal neurons.

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Section: Introductionmentioning

confidence: 99%

Botulinum toxin A modifies nociceptive withdrawal reflex in subacute stroke patients

Alvisi

Serrao²,

Conte

et al. 2018

Brain and Behavior

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“…The third study 32 demonstrated no significant change in functional assessment scores. The fourth, a more recent study, 33 showed improved response rate (.1 point) on the principal target of treatment of the Disability Assessment Scale (DAS), a measure of selfreported disability, at 4 weeks among participants treated with 1,000 U of aboBoNT-A, but not with 500 U or placebo (62% in 1,000 U, p 5 0.0018 vs placebo; 50% in 500 U, p 5 0.1279 vs placebo; and 39.2% in placebo). The higher-dose BoNT-A group also demonstrated improved active range of motion in the elbow, wrist, and fingers.…”

Section: Spasticity In Adultsmentioning

confidence: 92%

“…AboBoNT-A. Four new Class I trials [30][31][32][33] investigating aboBoNT-A demonstrated significant reductions in upper limb tone as measured by the modified Ashworth scale. These studies also measured functional outcomes.…”

Section: Spasticity In Adultsmentioning

confidence: 99%

Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache

et al. 2016

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Objective: To update the 2008 American Academy of Neurology (AAN) guidelines regarding botulinum neurotoxin for blepharospasm, cervical dystonia (CD), headache, and adult spasticity. Methods:We searched the literature for relevant articles and classified them using 2004 AAN criteria.Results and recommendations: Blepharospasm: OnabotulinumtoxinA (onaBoNT-A) and incobotulinumtoxinA (incoBoNT-A) are probably effective and should be considered (Level B). AbobotulinumtoxinA (aboBoNT-A) is possibly effective and may be considered (Level C). CD: AboBoNT-A and rimabotulinumtoxinB (rimaBoNT-B) are established as effective and should be offered (Level A), and onaBoNT-A and incoBoNT-A are probably effective and should be considered (Level B). Adult spasticity: AboBoNT-A, incoBoNT-A, and onaBoNT-A are established as effective and should be offered (Level A), and rimaBoNT-B is probably effective and should be considered (Level B), for upper limb spasticity. AboBoNT-A and onaBoNT-A are established as effective and should be offered (Level A) for lower-limb spasticity. Headache: OnaBoNT-A is established as effective and should be offered to increase headache-free days (Level A) and is probably effective and should be considered to improve health-related quality of life (Level B) in chronic migraine. OnaBoNT-A is established as ineffective and should not be offered for episodic migraine (Level A) and is probably ineffective for chronic tension-type headaches (Level B). Neurology ® 2016;86:1818-1826 GLOSSARY AAN 5 American Academy of Neurology; aboBoNT-A 5 abobotulinumtoxinA; AE 5 adverse event; BDI 5 Blepharospasm Disability Index; BoNT 5 botulinum neurotoxin; CD 5 cervical dystonia; CI 5 confidence interval; CM 5 chronic migraine; DAS 5 Disability Assessment Scale; EM 5 episodic migraine; incoBoNT-A 5 incobotulinumtoxinA; onaBoNT-A 5 onabotulinumtoxinA; QOL 5 quality of life; RD 5 risk difference; rimaBoNT-B 5 rimabotulinumtoxinB; RMT 5 randomized, masked trials; TWSTRS 5 Toronto Western Spasmodic Torticollis Rating Scale; TZD 5 tizanidine.

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“…Recent developments include deep brain stimulation, targeting primarily the dystonic component, 17 neuromodulation and motor training paradigms for functional recovery, 18 and chemodenervation (botulinum toxins) for spasticity, with expanding options and indications. [19][20][21] RESEARCH METHODOLOGY Data, registries, patient, and family involvement. Population-based CP registries exist worldwide, and mainly tabulate rates and types of CP.…”

Section: Variations In Clinical Practice and Thementioning

confidence: 99%

Report of a workshop on research gaps in the treatment of cerebral palsy

et al. 2016

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Cerebral palsy (CP) is heterogeneous in etiology and manifestations, making research into relevant therapies difficult and limiting the generalizability of the results. We report here on the NIH CP symposium, where stakeholders from academic, clinical, regulatory, and advocacy backgrounds discussed the major challenges and needs for moving forward with clinical research in CP, and outlined priorities and action items. New information is constantly generated through research into pathogenesis and etiology. Clinical research and new therapeutic approaches need to keep pace, through large data registry integration and new research designs. Development of standardized data collection, increasing academic focus on CP research, and iterative approaches to treatment throughout the patients' lives, have all been identified as areas of focus. The workshop identified critical gaps and areas of focus to increase the evidence base for therapeutic approaches to determine which treatments work best for which patients in the near future. These include consolidation and optimization of databases and registries, updates to the research methodology, and better integration of resources and stakeholders. DEFINING THE PROBLEM Cerebral palsy (CP) is a group of neurologic disorders of motor control with onset early in development and persistence throughout the lifespan. CP is the most common cause of motor disability in childhood, with an incidence of 2 to 3 per 1,000 live births, occurring 20 to 30 times more frequently in premature or low-birth-weight infants.1 These disturbances of movement and posture cause activity limitations.2 Those activity limitations resulting from spinal or neuromuscular disorders are excluded from the diagnosis. Various etiologies can cause the CP clinical spectrum but all have a disruption of motor control in common. In addition to prematurity, other known etiologies include developmental defects of the brain, perinatal stroke, hypoxia, shock, and fetal or neonatal inflammation/infection. However, CP may also occur in low-risk children for whom there is no obvious etiology or risk factor. CP is often accompanied by comorbidities such as seizures, communication deficits, hearing and vision deficits, and intellectual disability. There is a wide spectrum of functional outcomes from normal educational, career, and social activities to complete disability and dependence.An upper age limit for acquired pathology in the brain leading to CP is not absolute, but the onset of symptoms and the diagnosis are generally expected to occur by the age of 2. Given the heterogeneity in terms of etiology, pathology, clinical manifestations, and progression, it is best to consider CP as a collection of conditions rather than one uniform entity for developing treatment guidelines or conducting research on potential therapies.To address pressing research challenges, the National Institute of Neurological Disorders and Stroke (NINDS) organized a workshop with the main goal of discussing research needed to determine best ...

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Safety and efficacy of abobotulinumtoxinA for hemiparesis in adults with upper limb spasticity after stroke or traumatic brain injury: a double-blind randomised controlled trial

Cited by 175 publications

References 32 publications

Botulinum toxin A modifies nociceptive withdrawal reflex in subacute stroke patients

Botulinum toxin A modifies nociceptive withdrawal reflex in subacute stroke patients

Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache

Report of a workshop on research gaps in the treatment of cerebral palsy

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