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- Traumatic brain injury: Age at injury influences dementia risk after TBI. [JOURNAL ARTICLE]
- Nat Rev Neurol 2014 Dec 23.
- Can we measure long-term treatment effects in multiple sclerosis? [REVIEW]
- Nat Rev Neurol 2014 Dec 23.
The gold standard for measuring treatment effects is the randomized controlled trial. In patients with multiple sclerosis (MS), trial durations are typically 2-3 years, and the long-term effects of drugs for MS can only be assessed through trial extensions or observational studies that take advantage of data from registries or large single-centre databases. The main limitation of observational studies is an unavoidable selection bias that is introduced through nonrandom assignment of the intervention. Propensity score methods can mitigate this bias by balancing the groups with respect to baseline covariates, but this approach cannot correct for unmeasurable confounding factors. Extensions of clinical trials are free from selection biases because of the initial randomization, but they can only provide an assessment of early versus delayed treatment effects. Here, we discuss these methodological issues and analyse how they have been managed in studies of the long-term effects of IFN-β in patients with MS.
- Motor neuron disease in 2014: Biomarkers for ALS-in search of the Promised Land. [JOURNAL ARTICLE]
- Nat Rev Neurol 2014 Dec 23.
- Interactions between cognitive and sensory load while planning and controlling complex gait adaptations in Parkinson¿s disease. [JOURNAL ARTICLE]
- BMC Neurol 2014 Dec 21; 14(1):250.
BackgroundRecent research has argued that removal of relevant sensory information during the planning and control of simple, self-paced walking can result in increased demand on central processing resources in Parkinson¿s disease (PD). However, little is known about more complex gait tasks that require planning of gait adaptations to cross over an obstacle in PD.MethodsIn order to understand the interaction between availability of visual information relevant for self-motion and cognitive load, the current study evaluated PD participants and healthy controls while walking toward and stepping over an obstacle in three visual feedback conditions: (i) no visual restrictions; (ii) vision of the obstacle and their lower limbs while in complete darkness; (iii) vision of the obstacle only while in complete darkness; as well as two conditions including a cognitive load (with a dual task versus without a dual task). Each walk trial was divided into an early and late phase to examine changes associated with planning of step adjustments when approaching the obstacle.ResultsInteractions between visual feedback and dual task conditions during the obstacle approach were not significant. Patients with PD had greater deceleration and step time variability in the late phase of the obstacle approach phase while walking in both dark conditions compared to control participants. Additionally, participants with PD had a greater number of obstacle contacts when vision of their lower limbs was not available specifically during the dual task condition. Dual task performance was worse in PD compared to healthy control participants, but notably only while walking in the dark regardless of visual feedback.ConclusionsThese results suggest that reducing visual feedback while approaching an obstacle shifts processing to somatosensory feedback to guide movement which imposes a greater demand on planning resources. These results are key to fully understanding why trips and falls occur in those with PD.
- Incidence of multiple sclerosis in Northern Lisbon, Portugal: 1998¿2007. [JOURNAL ARTICLE]
- BMC Neurol 2014 Dec 21; 14(1):249.
BackgroundThere are few, recent, well assessed, multiple sclerosis (MS) incidence surveys on European populations. This study sought to measure MS incidence in a Northern Lisbon population and assess it using capture-recapture methods (CRMs).MethodsAmong the population residing in the Northern Lisbon Health Area, registered MS diagnoses were obtained from general practitioners in three primary-care districts covering a population of 196,300, and a neurology unit at the main referral hospital. Cases with onset during the periods 1978¿1997 and 2008¿2012 were excluded due to perceived poor access to image-supported neurological diagnosis and administrative changes in patient referral respectively. Age- and sex-specific incidences for the period 1998¿2007 were calculated using McDonald diagnostic criteria, and CRMs were used to correct age-specific incidence rates. The corrected figures were also adjusted for age using the European Standard Population as reference.ResultsWhen applied to 62 MS patients with onset in the period 1998¿2007, the rates per 100,000 population were as follows for both sexes: crude, 3.16; age-adjusted, 3.09 (95% CI 2.32 to 3.87); CRM-adjusted, 4.53 (95% CI 3.13 to 5.94); and age- and CRM-adjusted, 4.48 (3.54-5.41). In general, the rates were 3-fold higher among women than among men. Negative source dependency and CRM impact were highest at ages 35¿44 years, where a 60% rise led to a peak incidence.ConclusionsMS incidence in Northern Lisbon, Portugal, is moderately lower than that yielded by surveys on European populations. CRMs, which in this instance suggest undercounts, are a potentially useful tool for case-finding assessment but their application may introduce bias.
- A randomised controlled trial of an exercise plus behaviour change intervention in people with multiple sclerosis: the step it up study protocol. [JOURNAL ARTICLE]
- BMC Neurol 2014 Dec 21; 14(1):241.
BackgroundExercise has consistently yielded short-term, positive effects on health outcomes in people with multiple sclerosis (MS). However, these effects have not been maintained in the long-term. Behaviour change interventions aim to promote long-term positive lifestyle change. This study, namely, ¿Step it Up¿ will compare the effect of an exercise plus Social Cognitive Theory (SCT)-based behaviour change intervention with an exercise plus control education intervention on walking mobility among people with MS.Methods/designPeople with a diagnosis of MS who walk independently, score of 0¿3 on the Patient Determined Disease Steps, who have not experienced an MS relapse or change in their MS medication in the last 12 weeks and who are physically inactive will be randomised to one of two study conditions. The experimental group will undergo a 10-week exercise plus SCT-based behavioural change intervention. The control group will undergo a 10-week exercise plus education intervention to control for contact. Participants will be assessed at weeks 1, 12, 24 and 36. The primary outcome will be walking mobility. Secondary outcomes will include: aerobic capacity, lower extremity muscle strength, participant adherence to the exercise programme, self-report exercise intensity, self-report enjoyment of exercise, exercise self-efficacy, outcome expectations for exercise, goal-setting for exercise, perceived benefits and barriers to exercise, perceptions of social support, physical and psychological impact of MS and fatigue. A qualitative evaluation of Step it Up will be completed among participants post-intervention.DiscussionThis randomised controlled trial will examine the effectiveness of an exercise plus SCT-based behaviour change intervention on walking mobility among people with MS. To this end, Step it Up will serve to inform future directions of research and clinical practice with regard to sustainable exercise interventions for people with MS.Trial registrationClinicalTrials.gov, NCT02301442.
- Early supported discharge after stroke in Bergen (ESD Stroke Bergen): three and six months results of a randomised controlled trial comparing two early supported discharge schemes with treatment as usual. [JOURNAL ARTICLE]
- BMC Neurol 2014 Dec 21; 14(1):239.
BackgroundStroke causes lasting disability and the burden of stroke is expected to increase substantially during the next decades. Optimal rehabilitation is therefore mandatory. Early supported discharge (ESD) has previously shown beneficial, but all major studies were carried out more than ten years ago. We wanted to implement and study the results of ESD in our community today with comparisons between ESD and treatment as usual, as well as between two different ESD models.MethodsPatients with acute stroke were included during a three year period (2008¿11) in a randomised controlled study comparing two different ESD models to treatment as usual. The two ESD models differed by the location of treatment: either in a day unit or in the patients¿ homes. Patients in the ESD groups were followed by a multi-disciplinary ambulatory team in the stroke unit and discharged home as early as possible. The ESD models also comprised treatment by a multi-disciplinary community health team for up to five weeks and follow-up controls after 3 and 6 months. Primary outcome was modified Rankin Scale (mRS) at six months.ResultsThree-hundred-and-six patients were included. mRS scores and change scores were non-significantly better in the two ESD groups at 3 and 6 months. Within-group improvement from baseline to 3 months was significant in the ESD 1 (p¿=¿0.042) and ESD 2 (p¿=¿0.001) groups, but not in the controls. More patients in the pooled ESD groups were independent at 3 (p¿=¿0.086) and 6 months (p¿=¿0.122) compared to controls and there also was a significant difference in 3 month change score between them (p¿=¿0.049). There were no differences between the two ESD groups. Length of stay in the stroke unit was 11 days in all groups.ConclusionsPatients in the ESD groups tended to be more independent than controls at 3 and 6 months, but no clear statistically significant differences were found. The added effect of supported discharge and improved follow-up seems to be rather modest. The improved stroke treatment of today may necessitate larger patient samples to demonstrate additional benefit of ESD.Clinical trial registrationUnique identifier: NCT00771771.
- Phase II study of monthly pasireotide LAR (SOM230C) for recurrent or progressive meningioma. [JOURNAL ARTICLE]
- Neurology 2014 Dec 19.
A subset of meningiomas recur after surgery and radiation therapy, but no medical therapy for recurrent meningioma has proven effective.Pasireotide LAR is a long-acting somatostatin analog that may inhibit meningioma growth. This was a phase II trial in patients with histologically confirmed recurrent or progressive meningioma designed to evaluate whether pasireotide LAR prolongs progression-free survival at 6 months (PFS6). Patients were stratified by histology (atypical [World Health Organization grade 2] and malignant [grade 3] meningiomas in cohort A and benign [grade 3] in cohort B).Eighteen patients were accrued in cohort A and 16 in cohort B. Cohort A had median age 59 years, median Karnofsky performance status 80, 17 (94%) had previous radiation therapy, and 11 (61%) showed high octreotide uptake. Cohort B had median age 52 years, median Karnofsky performance status 90, 11 (69%) had previous radiation therapy, and 12 (75%) showed high octreotide uptake. There were no radiographic responses to pasireotide LAR therapy in either cohort. Twelve patients (67%) in cohort A and 13 (81%) in cohort B achieved stable disease. In cohort A, PFS6 was 17% and median PFS 15 weeks (95% confidence interval: 8-20). In cohort B, PFS6 was 50% and median PFS 26 weeks (12-43). Treatment was well tolerated. Octreotide uptake and insulin-like growth factor-1 levels did not predict outcome. Expression of somatostatin receptor 3 predicted favorable PFS and overall survival.Pasireotide LAR has limited activity in recurrent meningiomas. The finding that somatostatin receptor 3 is associated with favorable outcomes warrants further investigation.This study provides Class IV evidence that in patients with recurrent or progressive meningioma, pasireotide LAR does not significantly increase the proportion of patients with PFS at 6 months.
- Leukoencephalopathy: "Before concluding treatment efficacy…" [EDITORIAL]
- Neurology 2014 Dec 19.