Posts Tagged Botulinum Toxin-A

[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

Abstract

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

 

Figure 1 Process of application of measures in the ULIS-III study. BoNT-A, botulinum toxin A; GAS-eous, Goal Attainment Scaling—Evaluation of Outcome for Upper Limb Spasticity; ULIS-III, third study in the Upper Limb International Spasticity programme.

 

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[Abstract] Pharmacokinetics and pharmacodynamics of incobotulinumtoxin A influencing the clinical efficacy in post-stroke spasticity – Expert Opinion on Drug Metabolism & Toxicology –

Pharmacokinetics and pharmacodynamics of incobotulinumtoxin A influencing the clinical efficacy in post-stroke spasticityAbstract

Introduction: Post-stroke spasticity is a disabling neurological condition and may have a significant impact on quality of life. Ability to carry out activities of daily living is often compromised and painful contractures in the affected limbs may also develop. The prevalence of spasticity may be as high as 40% within the first year after the initial stroke event. Management of this condition focuses on improving muscle tone, function and pain. IncobotulinumtoxinA is effective in treating focal spasticity.
Areas covered: This review will summarize outcomes from incobotulinumtoxin A phase III trials in upper limb spasticity. Pharmacodynamics and pharmacokinetics will also be discussed along with future studies and possible indications. Literature searches used for this review include; PubMed and http://www.clinicaltrials.gov searches. Congress abstracts and case reports are not included.
Expert opinion: IncobotulinumtoxinA, is a 150 kiloDalton neurotoxin without complexing proteins and is well tolerated in patients with spasticity. There is an 80% improvement reported i spasticity and disability in several phase III studies. In the future, higher doses for upper and lower limb spasticity may be considered. Antibody formation does not seem to limit the administration of higher doses. Prospective studies are evaluating the efficacy of incobotulinumtoxin in children and adolescents with cerebral palsy. Furthermore, the clinical efficacy and immunogenic status of other botulinum neurotoxin A subtypes are currently under investigation.

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Source: Pharmacokinetics and pharmacodynamics of incobotulinumtoxin A influencing the clinical efficacy in post-stroke spasticity – Expert Opinion on Drug Metabolism & Toxicology –

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[ARTICLE] Changes in cerebellar activation following onabotulinumtoxin A injections for spasticity after chronic stroke: A pilot fMRI study

Abstract

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)

via Changes in cerebellar activation following onabotulinumtoxin A injections for spasticity after chronic stroke: A pilot fMRI study – Archives of Physical Medicine and Rehabilitation.

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[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

Abstract

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.

Full Text HTML —> Toxins | Free Full-Text | 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 | HTML.

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[WEB SITE] Articles about Botulinum Toxin A and Spasticity

 

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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…

via The Impact of Botulinum Toxin and Upper Limb Rehabilitation on Spasticity, Function and Pain: A Systematic Review – Archives of Physical Medicine and Rehabilitation.

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[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…

http://www.archives-pmr.org/article/S0003-9993(14)00412-2/abstract?rss=yes

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