Duration of Treatment Effect Using IncobotulinumtoxinA for Upper-limb Spasticity: A Analysis.

The efficacy and safety of incobotulinumtoxinA ≤400 U was demonstrated in subjects with post-stroke upper-limb spasticity in a randomized, double-blind Phase 3 study with an open-label extension (OLEX; EudraCT number 2005-003951-11, NCT00432666). We report a analysis of the duration of the treatment effect. Subjects completing the placebo-controlled main period (single injection cycle with 12-20-week observation) entered the OLEX and received a maximum of five further treatments (maximum duration 69 weeks) with incobotulinumtoxinA ≤400 U at flexible intervals with a minimum duration of 12 weeks, based on clinical need.

Sustained efficacy of incobotulinumtoxina repeated injections for upper-limb post-stroke spasticity: A post hoc analysis.

Objective: This post hoc analysis assessed the impact of repeated incobotulinumtoxinA injections on muscle tone, disability, and caregiver burden in adults with upper-limb post-stroke spasticity.

Design: Data from the double-blind, placebo-controlled main period and three open-label extension cycles of two Phase 3, randomized, multicentre trials were pooled.

Methods: Subjects received incobotulinumtoxinA 400 Units at 12-week intervals (±3 days) (study 3001, NCT01392300) or ≤ 400 Units at ≥12-week intervals based on clinical need (study 0410, NCT00432666).

IncobotulinumtoxinA Treatment in Upper-Limb Poststroke Spasticity in the Open-Label Extension Period of PURE: Efficacy in Passive Function, Caregiver Burden, and Quality of Life.

Background: Poststroke spasticity affects motor function and the ability to perform activities of daily living, with the potential to affect quality of life (QoL) and increase caregiver burden.

Objective: To investigate the effect of repeated incobotulinumtoxinA treatment on spasticity-associated functional disability, caregiver burden, and QoL in the 36-week open-label extension of the phase 3 PURE study (NCT01392300).

Design: Open-label extension period of a prospective, double-blind, placebo-controlled, randomized, multicenter study.

MiR-499 Responsive Lethal Construct for Removal of Human Embryonic Stem Cells after Cardiac Differentiation.

Deriving cell populations from human embryonic stem cells (hESCs) for cell-based therapy is considered a promising strategy to achieve functional cells, yet its translation to clinical practice depends on achieving fully defined differentiated cells. In this work, we generated a miRNA-responsive lethal mRNA construct that selectively induces rapid apoptosis in hESCs by expressing a mutant (S184del) Bax variant. Insertion of miR-499 target sites in the construct enabled to enrich hESC-derived cardiomyocytes (CMs) in culture.

IncobotulinumtoxinA Efficacy and Safety in Adults with Upper-Limb Spasticity Following Stroke: Results from the Open-Label Extension Period of a Phase 3 Study.

Introduction: The objective of the study was to investigate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper-limb post-stroke spasticity in adults.

Methods: Adults 18-80 years of age with post-stroke upper-limb spasticity who completed the 12-week randomized, double-blind, placebo-controlled main period (MP) of a phase 3 trial (NCT01392300) were eligible to enrol in the 36-week open-label extension period (OLEX). The OLEX included three treatment cycles at fixed 12-week injection intervals; subjects were injected with 400 U incobotulinumtoxinA into the affected upper limb.

Patient Registry of Spasticity Care World: Data Analysis Based on Physician Experience.

Objective: The aim of the study was to report physician experience-based "real-world" treatment patterns with botulinum toxin type A in patients with stroke and traumatic brain injury.

Design: A prospective, multicenter, international observational registry design was used.

Results: Six hundred twenty-seven participants with stroke and 132 participants with traumatic brain injury were assessed and treated by 17 more experienced physicians and 12 less experienced physicians.

A bridge to silencing: Co-assembling anionic nanoparticles of siRNA and hyaluronan sulfate via calcium ion bridges.

Therapeutic implementation of RNA interference (RNAi) through delivery of short interfering RNA (siRNA) is still facing several critical hurdles, which mostly can be solved through the use of an efficient delivery system. We hereby introduce anionic siRNA nanoparticles (NPs) co-assembled by the electrostatic interactions of the semi-synthetic polysaccharide hyaluronan-sulfate (HAS), with siRNA, mediated by calcium ion bridges. The NPs have an average size of 130nm and a mild (-10mV) negative surface charge.

Cognitive effects of modafinil in patients with multiple sclerosis: A clinical trial.

Purpose/objective: To assess the efficacy of modafinil for the treatment of new learning and memory deficits and fatigue in multiple sclerosis. Only 1 previous study in the literature, to our knowledge, examined the effect of modafinil on cognition specifically in persons with multiple sclerosis.

Research Method/design: Sixteen patients with a diagnosis of multiple sclerosis (MS) and documented new learning impairment completed the study.

Randomized, placebo-controlled trial of incobotulinumtoxina for upper-limb post-stroke spasticity.

Introduction: Efficacy and safety of incobotulinumtoxinA in post-stroke upper-limb spasticity were studied.

Methods: Subjects randomized 2:1 to incobotulinumtoxinA (fixed dose 400 U) or placebo, with fixed doses for the primary target clinical pattern (PTCP; flexed elbow, 200 U; flexed wrist, 150 U; clenched fist, 100 U). Doses for non-primary patterns were flexible within predefined ranges.

Evidence-based review and assessment of botulinum neurotoxin for the treatment of urologic conditions.

Botulinum neurotoxin (BoNT) can be injected to achieve therapeutic benefit across a large range of clinical conditions. To assess the efficacy and safety of BoNT injections for the treatment of certain urologic conditions, including detrusor sphincter dyssynergia (DSD), lower urinary tract symptoms due to benign prostatic hyperplasia (BPH), and detrusor overactivity (both neurogenic [NDO] and idiopathic [IDO]), an expert panel reviewed evidence from the published literature. Data sources included English-language studies identified via MEDLINE, EMBASE, CINAHL, Current Contents, and the Cochrane Central Register of Controlled Trials.

Evidence-based review and assessment of botulinum neurotoxin for the treatment of adult spasticity in the upper motor neuron syndrome.

Botulinum neurotoxin (BoNT) can be injected to achieve therapeutic benefit across a large range of clinical conditions. To assess the efficacy and safety of BoNT injections for the treatment of spasticity associated with the upper motor neuron syndrome (UMNS), an expert panel reviewed evidence from the published literature. Data sources included English-language studies identified via MEDLINE, EMBASE, CINAHL, Current Contents, and the Cochrane Central Register of Controlled Trials.

Patient registry of outcomes in spasticity care.

Objective: This study aimed to provide clinical injection data and real-world patient-reported and clinical outcomes for the chemodenervation and neurolytic treatment of muscle overactivity including spasticity in patients with traumatic brain injury and stroke.

Design: This study used a prospective multicenter observational design. The participants were 487 patients with stroke or traumatic brain injury.

Relationship between disability and health-related quality of life and caregiver burden in patients with upper limb poststroke spasticity.

Objective: To evaluate the relationship between disability and both health-related quality of life (HRQoL) and caregiver burden in patients with upper limb poststroke spasticity.

Design: Multicenter open-label study.

Setting: Thirty-five sites in North America.

Evaluation of a dynamic ankle foot orthosis in hemiplegic gait: A case report.

This investigation utilized a single case design to evaluate the effects of a dynamic AFO on ambulation in post stroke hemiplegia. A single patient with stroke related hemiplegia using a dynamic AFO underwent gait analysis while walking on level ground. Outcome measures included temporal-spatial gait parameters and bilateral kinematic joint angles at the ankle, knee, and hip with and without AFO.

Common data elements in radiologic imaging of traumatic brain injury.

Traumatic brain injury (TBI) has a poorly understood pathology. Patients suffer from a variety of physical and cognitive effects that worsen as the type of trauma worsens. Some noninvasive insights into the pathophysiology of TBI are possible using magnetic resonance imaging (MRI), computed tomography (CT), and many other forms of imaging as well.

Compound muscle action potential and motor function in children with spinal muscular atrophy.

Reliable outcome measures that reflect the underlying disease process and correlate with motor function in children with SMA are needed for clinical trials. Maximum ulnar compound muscle action potential (CMAP) data were collected at two visits over a 4-6-week period in children with SMA types II and III, 2-17 years of age, at four academic centers. Primary functional outcome measures included the Modified Hammersmith Functional Motor Scale (MHFMS) and MHFMS-Extend.

Examining the relationship between cognition and driving performance in multiple sclerosis.

Objective: To identify cognitive predictors of driving performance after multiple sclerosis (MS).

Design: Prospective design examining predictive value of cognitive measures on driving performance.

Setting: All data were collected in an outpatient research setting and an outpatient driver rehabilitation program.

Chemodenervation and nerve blocks in the diagnosis and management of spasticity and muscle overactivity.

This article will discuss many of the key concepts regarding chemodenervation and neurolysis in the management of spasticity. Topics that will be discussed include techniques for localization, strengths and limitations of various agents (botulinum toxin, phenol, and alcohol), the value of combination therapies, and the role of nerve blocks (diagnostic and therapeutic). With advancing technology have come newer methods to improve accuracy of localization for the performance of chemodenervation and neurolysis such as electromyographic guidance, electrical stimulation, and ultrasound guidance.

Objective assessment of functional ambulation in adults with hemiplegia using ankle foot orthotics after stroke.

Objective: To objectively evaluate the effect of ankle foot orthotics (AFOs) on functional ambulation in individuals with hemiplegia secondary to stroke using quantifiable outcome measures.

Design: With-without repeated measures design.

Setting: Rehabilitation research center.

Contralateral weakness and fatigue after high-dose botulinum toxin injection for management of poststroke spasticity.

A 53-yr-old woman developed contralateral weakness and fatigue, without autonomic symptoms, 2 wks after receiving an injection with 800 units of botulinum toxin A for management of her poststroke spasticity. Although the patient reported resolution 4 wks later, clinical evaluations suggested an even longer time course. The patient then experienced the same contralateral symptoms again more than a year later, after a 500-unit injection, which took a similar length of time to resolve.

Repeated treatments with botulinum toxin type a produce sustained decreases in the limitations associated with focal upper-limb poststroke spasticity for caregivers and patients.

Objective: To assess the safety and evaluate the effects of repeated treatments with botulinum toxin type A (BTX-A) on functional disability, quality of life (QOL), and muscle tone of patients with upper-limb poststroke spasticity, as well as its effect on caregivers.

Design: Multicenter, open-label, repeated-dose study.

Setting: Thirty-five clinical sites in North America.

MRI findings in the painful poststroke shoulder.

Background And Purpose: We describe the structural abnormalities in the painful shoulder of stroke survivors and their relationships to clinical characteristics. Method- Eighty-nine chronic stroke survivors with poststroke shoulder pain underwent T1- and T2-weighted multiplanar, multisequence MRI of the painful paretic shoulder. All scans were reviewed by one radiologist for the following abnormalities: rotator cuff, biceps and deltoid tears, tendinopathies and atrophy, subacromial bursa fluid, labral ligamentous complex abnormalities, and acromioclavicular capsular hypertrophy.