Posts Tagged Botulinum Toxin-A
[Abstract] Efficacy and safety of NABOTA in post-stroke upper limb spasticity: A phase 3 multicenter, double-blinded, randomized controlled trial
A phase III clinical trial was performed for a novel botulinum toxin A, NABOTA, on post-stroke upper limb spasticity.
NABOTA demonstrated non-inferiority on efficacy and safety compared to onabotulinum toxin A (Botox).
NABOTA may serve as an alternative for treatment of post-stroke upper limb spasticity using botulinum toxin A.
Botulinum toxin A is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. Efficacy and safety of a new botulinum toxin type A, NABOTA (DWP450) in post-stroke upper limb spasticity was evaluated in comparison with Botox (onabotulinum toxin A). A total of 197 patients with post-stroke upper limb spasticity were included in this study and randomly assigned to NABOTA group (n = 99) or Botox group (n = 98). Wrist flexors with modified Ashworth Scale (MAS) grade 2 or greater, and elbow flexors, thumb flexors and finger flexors with MAS 1 or greater were injected with either drug. The primary outcome was the change of wrist flexor MAS between baseline and 4 weeks post-injection. MAS of each injected muscle, Disability Assessment Scale (DAS), and Caregiver Burden Scale were also assessed at baseline and 4, 8, and 12 weeks after the injection. Global Assessment Scale (GAS) was evaluated on the last visit at 12 weeks. The change of MAS for wrist flexor between baseline and 4 weeks post-injection was − 1.44 ± 0.72 in the NABOTA group and − 1.46 ± 0.77 in the Botox group. The difference of change between both groups was 0.0129 (95% confidence interval − 0.2062–0.2319), within the non-inferiority margin of 0.45. Both groups showed significant improvements regarding MAS of all injected muscles, DAS, and Caregiver Burden Scale at all follow-up periods. There were no significant differences in all secondary outcome measures between the two groups. NABOTA demonstrated non-inferior efficacy and safety for improving upper limb spasticity in stroke patients compared to Botox.
[ARTICLE] Impact of integrated upper limb spasticity management including botulinum toxin A on patient-centred goal attainment: rationale and protocol for an international prospective, longitudinal cohort study (ULIS-III) – Full Text HTML
Objectives Describe the rationale and protocol for the Upper Limb International Spasticity (ULIS)-III study, which aims to evaluate the impact of integrated spasticity management, involving multiple botulinum toxin A (BoNT-A) injection cycles and concomitant therapies, on patient-centred goal attainment. Outline novel outcome assessment methods for ULIS-III and report initial evaluation data from goal setting in early stages of the study.
Design Large international longitudinal cohort study of integrated upper limb spasticity management, including BoNT-A.
Participants and setting ULIS-III is a 2-year study expected to enrol >1000 participants at 58 study centres across 14 countries.
Interventions The study design is non-interventional and intended to reflect real-life clinical practice. It will describe injection practices and additional treatment strategies, and record clinical decision-making in a serial approach to long-term spasticity management.
Outcome measures ULIS-III will use a goal-directed approach to selection of targeted standardised measures to capture the diversity of presentation, goals and outcomes. ULIS-III will implement the Upper Limb Spasticity Index, a battery of assessments including a structured approach to goal attainment scaling (Goal Attainment Scaling—Evaluation of Outcomes for Upper Limb Spasticity tool), alongside a limited set of standardised measures, chosen according to patients’ selected goal areas. Concomitant therapy inputs, patient satisfaction with engagement in goal setting, health economic end points and health-related quality of life data will also be captured.
Results of initial evaluation of goal quality Recruitment started in January 2015. By June 2015, 58 sites had been identified and initial data collected for 79 patients across 13 sites in 3 countries. Goal setting data were quality-checked and centres rated on the basis of function-related and Specific, Measurable, Achievable, Realistic, Timed (SMART) characteristics of goal statements. Overall, 11/13 centres achieved the highest rating (A++).
Conclusions ULIS-III will provide valuable information regarding treatment of and outcomes from real-life upper limb spasticity management worldwide.
Trial registration number NCT02454803; Pre-results.
Strengths and limitations of this study
The Upper Limb International Spasticity (ULIS)-III is the first large international longitudinal cohort study to describe real-life clinical practice and decision-making in spasticity management over a 2-year period of treatment.
The structured approach to goal attainment scaling linked to targeted standardised measures will improve comparability of outcomes while maintaining a patient-centred approach. This approach may also have broader application for outcome measurement in other areas of healthcare.
This study introduces new tools to capture therapy interventions and spasticity-related quality of life. While not yet fully validated, they address areas that are poorly described in other studies; ULIS-III will enable further validation.
Training and proactive feedback on the standard of goals set from an early stage in the study has helped to ensure high-quality goal setting.
This study represents a diverse sample of practice across four continents; however, the limited number of subjects per centre (n=20–30) could lead to a degree of selection bias.
Continue —> Impact of integrated upper limb spasticity management including botulinum toxin A on patient-centred goal attainment: rationale and protocol for an international prospective, longitudinal cohort study (ULIS-III) — Turner-Stokes et al. 6 (6) — BMJ Open
[Abstract] Pharmacokinetics and pharmacodynamics of incobotulinumtoxin A influencing the clinical efficacy in post-stroke spasticity – Expert Opinion on Drug Metabolism & Toxicology –
[ARTICLE] Changes in cerebellar activation following onabotulinumtoxin A injections for spasticity after chronic stroke: A pilot fMRI study
Objective: To investigate the effect of reducing spasticity via Obtx-A injection on cerebellar activation after chronic stroke during unilateral gripping.
Design: Pre-post, case series.
Setting: Outpatient spasticity clinic.
Participants: Four individuals with chronic spasticity.
Interventions: Upper limb Obtx-A injections
Outcome Measures: Functional magnetic resonance imaging (fMRI) was used to measure changes in cerebellar activation before and after upper limb Obtx-A injections. During fMRI testing, participants performed the same motor task before and after injection, which is 15% and 30% of maximum voluntary isometric gripping measured before Obtx-A injection.
Results: After Obtx-A injections, cerebellar activation increased bilaterally during gripping with the paretic hand and during rest. During both pre- and post-injection scans, the paretic hand showed larger cerebellar activation during gripping compared to the non-paretic hand. Cerebellar activation during gripping with the non-paretic hand did not change significantly after Obtx-A injections.
Conclusions: Reducing spasticity via Obtx-A injections may increase cerebellar activation both during gripping tasks with the paretic hand and during rest. To our knowledge, this is the first study that examines changes in cerebellar activation after spasticity treatment with Obtx-A.
Abbreviations: central nervous system (CNS), Onabotulinumtoxin A (Obtx-A), acetylcholine (Ach), Chedoke-McMaster Assessment (CMA), functional magnetic resonance imaging (fMRI), blood-oxygen-level dependent (BOLD), Modified Ashworth scores (MAS), echo planar imaging (EPI)
[ARTICLE] Factors Influencing Goal Attainment in Patients with Post-Stroke Upper Limb Spasticity Following Treatment with Botulinum Toxin A in Real-Life Clinical Practice: Sub-Analyses from the Upper Limb International Spasticity (ULIS)-II Study – Full Text HTML
In this post-hoc analysis of the ULIS-II study, we investigated factors influencing person-centred goal setting and achievement following botulinum toxin-A (BoNT-A) treatment in 456 adults with post-stroke upper limb spasticity (ULS). Patients with primary goals categorised as passive function had greater motor impairment (p < 0.001), contractures (soft tissue shortening [STS]) (p = 0.006) and spasticity (p = 0.02) than those setting other goal types. Patients with goals categorised as active function had less motor impairment (0.0001), contracture (p < 0.0001), spasticity (p 1 year)) post-stroke (80.0% vs. 79.2%) or presence or absence of severe contractures (76.7% vs. 80.6%), although goal types differed. Earlier BoNT-A intervention was associated with greater achievement of active function goals. Severe contractures impacted negatively on goal achievement except in pain and passive function. Goal setting by patients with ULS is influenced by impairment severity, age and time since stroke. Our findings resonate with clinical experience and may assist patients and clinicians in selecting realistic, achievable goals for treatment.
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[POSTER] The Impact of Botulinum Toxin and Upper Limb Rehabilitation on Spasticity, Function and Pain: A Systematic Review
…The combination of BoNTA with UL rehabilitation decreased spasticity to a greater extent than UL rehabilitation plus placebo or UL rehabilitation alone at the 4 week time point only. BoNTA administration did not impact UL function or pain at either the 4 or 12 week post-intervention time point…
[ARTICLE] Measuring Spasticity and Fine Motor Control (Pinch) Change in the Hand After Botulinum Toxin-A Injection Using Dynamic Computerized Hand Dynamometry
…To evaluate change in fine motor hand performance and to investigate the relationship between existing clinical measures and dynamic computerized dynamometry (DCD) after botulinum toxin-A (BTX-A) injections for adults with upper limb spasticity…