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Neurology current issue
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- Clinical Reasoning: A 52-year-old woman with subacute hemichorea
- Teaching NeuroImage: Hippocampal involvement in a patient with hypoglycemic coma
- This week in Neurology(R): Highlights of the November 11 issue
- Why surrogate consent is important: A role for data in refining ethics policy and practice
- Reducing the risk of epilepsy: Using the pharmacy for more than drug dispensing
- How important is surrogate consent for stroke research?
Background: Patients with stroke may have cognitive deficits that impact their capacity to provide informed consent for research. Some institutional review boards restrict surrogate consent to persons who have specific legal authority to provide it. We examined the importance of surrogate consent in the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA Stroke Trial, the study that led to the only US Food and Drug Administration–approved treatment for acute ischemic stroke.
Methods: The NINDS rt-PA Stroke Trial randomized subjects with ischemic stroke to treatment with recombinant tissue plasminogen activator (rt-PA) or placebo. We compared the baseline characteristics and clinical outcomes of subjects enrolled by self-consent with those of subjects enrolled by surrogate consent.
Results: Surrogate consent was used to enroll 439 of 624 (70%) subjects. Subjects enrolled by surrogate consent were older (68.5 vs 63.4 years, p < 0.001), had more severe strokes (median NIH Stroke Scale score 17 vs 9, p < 0.001), and were less likely to make a good recovery (p < 0.001 for all measures) than patients who provided their own consent. There was no interaction between method of consent and response to rt-PA. If the trial had used the same sample size and recruited at the same rate but excluded patients who could not provide their own consent, it would have taken 12.5 years to complete.
Conclusions: The National Institute of Neurological Disorders and Stroke recombinant tissue plasminogen activator (rt-PA) Stroke Trial would not have been completed in a timely fashion without subjects enrolled by surrogate consent. Furthermore, exclusion of subjects who could not provide their own consent would have severely limited the generalizability and value of trial results.
- Nonadherence to antiepileptic drugs and increased mortality: Findings from the RANSOM Study
Objectives: The primary objective was to investigate whether nonadherence to antiepileptic drugs (AEDs) is associated with increased mortality and the secondary objective to examine whether nonadherence increases the risk of serious clinical events, including emergency department (ED) visits, hospitalizations, motor vehicle accident (MVA) injuries, fractures, and head injuries.
Methods: A retrospective open-cohort design was employed using Medicaid claims data from Florida, Iowa, and New Jersey from January 1997 through June 2006. Patients aged ≥18 years with ≥1 diagnosis of epilepsy by a neurologist and ≥2 AED pharmacy dispensings were selected. Medication possession ratio (MPR) was used to evaluate AED adherence on a quarterly basis with MPR ≥0.80 considered adherent and <0.80 nonadherent. The association of nonadherence with mortality was assessed using a time-varying Cox regression model adjusting for demographic and clinical confounders. Incidence rates for serious clinical events were compared between adherent and nonadherent quarters using incidence rate ratios (IRRs) with 95% CIs calculated based on the Poisson distribution.
Results: The 33,658 study patients contributed 388,564 AED-treated quarters (26% nonadherent). Nonadherence was associated with an over threefold increased risk of mortality compared to adherence (hazard ratio = 3.32, 95% CI = 3.11–3.54) after multivariate adjustments. Time periods of nonadherence were also associated with a significantly higher incidence of ED visits (IRR = 1.50, 95% CI = 1.49–1.52), hospital admissions (IRR = 1.86, 95% CI = 1.84–1.88), MVA injuries (IRR = 2.08, 95% CI = 1.81–2.39), and fractures (IRR = 1.21, 95% CI = 1.18–1.23) than periods of adherence.
Conclusion: These findings suggest that nonadherence to antiepileptic drugs can have serious or fatal consequences for patients with epilepsy.
- Foreign language ictal speech automatisms in nondominant temporal lobe epilepsy
Background: Foreign language ictal speech automatism (FLISA) is a rare ictal sign that has been hitherto reported in five unilingual patients, all right handed men with right temporal lobe epilepsy (TLE), only one of whom has benefited from an intracerebral EEG investigation.
Methods: We report three unilingual French patients who consistently presented English spoken ictal speech automatisms and were investigated with intracerebral EEG recordings.
Results: All three patients were right-handed men with nondominant TLE originating in the right amygdala. However, FLISA only occurred when the ictal EEG discharge spread to the ipsilateral temporal neocortex or frontal operculum. In addition, FLISA were emotionally salient, referring to the patient’s parents or to the intensity of the ongoing seizure.
Conclusion: Our findings, together with previously published data, suggest that foreign language ictal speech automatisms are more likely to occur in men with nondominant amygdala onset seizures, an observation that might reflect the sexual dimorphism observed in the right amygdala during emotional processing.
- Randomized, controlled, dose-ranging trial of carisbamate for partial-onset seizures
Objective: To evaluate the efficacy, safety, and tolerability of carisbamate (CRS), an investigational drug, as adjunctive treatment for partial-onset seizures in adults.
Methods: A randomized, double-blind, placebo-controlled, multicenter, dose-ranging study was conducted in 12 countries. Patients counted seizures during an 8-week baseline period, and then, if eligible, entered a double-blind phase consisting of a 4-week dose-titration period (target CRS doses: 100, 300, 800, or 1,600 mg/d or placebo in two divided doses) and a 12-week maintenance period. The primary efficacy variable was percent reduction in partial-onset seizure frequency during the double-blind phase compared with pretreatment baseline. Safety data and responder rates were also assessed.
Results: Five hundred thirty-seven patients were randomized, and 82% completed the study. In the intent-to-treat population (n = 533), CRS at doses of ≥300 mg/d (p ≤ 0.006) reduced the frequency of partial-onset seizures vs placebo: 6% (placebo) vs 24% (300 mg/d), 21% (800 mg/d), and 29% (1,600 mg/d) for CRS. Adverse events consisted primarily of CNS effects, and led to discontinuation of drug in 8% of the placebo group vs 5% (100 mg/d), 6% (300 mg/d), 12% (800 mg/d), and 19% (1,600 mg/d) of the CRS groups.
Conclusions: Carisbamate at doses of 300, 800, and 1,600 mg/d was effective as adjunctive therapy for reducing the frequency of partial-onset seizures.
GLOSSARY: AED = antiepileptic drug; ALT = alanine aminotransferase; AST = aspartate aminotransferase; CRS = carisbamate; LFT = liver function test; TEAE = treatment-emergent adverse event; UGT = uridine diphosphate glucuronosyltransferase.
- FDG-PET/MRI coregistration improves detection of cortical dysplasia in patients with epilepsy
Objective: Patients with cortical dysplasia (CD) are difficult to treat because the MRI abnormality may be undetectable. This study determined whether fluorodeoxyglucose (FDG)-PET/MRI coregistration enhanced the recognition of CD in epilepsy surgery patients.
Methods: Patients from 2004–2007 in whom FDG-PET/MRI coregistration was a component of the presurgical evaluation were compared with patients from 2000–2003 without this technique. For the 2004–2007 cohort, neuroimaging and clinical variables were compared between patients with mild Palmini type I and severe Palmini type II CD.
Results: Compared with the 2000–2003 cohort, from 2004–2007 more CD patients were detected, most had type I CD, and fewer cases required intracranial electrodes. From 2004–2007, 85% of type I CD cases had normal non–University of California, Los Angeles (UCLA) MRI scans. UCLA MRI identified CD in 78% of patients, and 37% of type I CD cases had normal UCLA scans. EEG and neuroimaging findings were concordant in 52% of type I C