Where there are either a limited number of studies, the available studies are too small or only poor quality studies are available then the data is considered insufficient to allow a conclusion to be reached on the likelihood of a causal association. Clinical data on reproductive toxic effects are limited and the findings are mixed. Individual pregnancy registry and population-based cohort studies have reported increased risks of fetal loss with carbamazepine compared with unexposed women with epilepsy (Artama et al 2013, Trivedi et al 2018). However, the meta-analysis by Veroniki et al (2017a) that included data on 3,911 carbamazepine monotherapy exposed pregnancies did not support an increased risk of fetal loss compared with unexposed women with epilepsy (OR 1.25, 95% credible intervals 0.73 to 2.36). Randomised controlled clinical trials are usually considered the best evidence to support a causal association. However, because pregnant women are rarely included in randomised controlled clinical trials, once a product is marketed the aim is to collect information on safety in pregnancy in order that better information can be provided to patients and healthcare professionals.
The Learning Rhythms
Lists of linear words does not engage the intuitive, right side of our brain. A much more effective way to do this is to use a technique called Mind Mapping®. Regular use of such visual, organic, branching techniques is brain-friendly, and encourages learning through visualisation and realisation of the interconnectedness of our internal and external worlds.
- Kaneko (132 exposed pregnancies), found a clear but not statistically significant positive trend between dose and incidence of malformation based on 132 phenytoin-exposed pregnancies.
- As CerebrumIQ reviews pile up online, many users comment not on the validity of the test’s logic puzzles or pattern recognition questions, but on the internal impact of their results.
- And about 30 to 40 of the 100 children will go on to have disorders affecting their learning and thinking abilities, including autism.
The Brain Training Puzzle Book: Boredom Busting Activities to Exercise the Mind Paperback – 2 Jun. 2021
Simply doing things does not require much interplay between your neo-cortex and your memory database. Unfortunately, this research only looks at the cerebral cortex; cerebro-cerebellar connectivity and the thickness of the cerebellar cortex was not included in their fMRI data. That said, the researchers thoroughly investigated the relationship between the cortical thickness across the entire cerebral cortex and the resting-state functional connectivity between 200 distinct brain regions within the cerebrum based on data from the human connectome project (HCP). Profound Multiple Learning Disabilities (PMLD)PMLD is another term to separate the most severely learning delayed from others with learning delays, so that support can be matched. Anything that means learning is severely affected can be included in this group. PMLD indicates a severe level of need, but little more as the subject is so vast.
Regulatory compliant study
There are extremely limited clinical data available to inform on the effect of topiramate exposure during pregnancy and the risk of neurodevelopmental disorders in the offspring. Data from a very small study by Rihtman et al (2012), that involved only 9 children whose mothers had taken topiramate during pregnancy suggested that, compared with control children, topiramate had an adverse effect cerebrumiq on cognitive, motor, and behavioural outcomes, as well as on IQ score, and motor and visual spatial skills. In contrast, a retrospective observational study in the UK Epilepsy and Pregnancy Registry (Bromley et al 2016b) reported on data for 27 children who had prenatal exposure to topiramate and the findings did not suggest reductions in the cognitive abilities of the children.
Studies that explore a dose-dependent risk are very limited but where this was studied (Nulman et al 1997, Samren et al 1997, Kaneko et al 1999, Kaaja 2003, Hernandez-Diaz et al 2012) the data do not consistently show an association between dose and risk of major congenital malformations. Of these studies, only Samren 1997 and Kaneko et al 1999 reported a dose-effect. Samren conducted a very small study involving 33 phenytoin exposed pregnancies. Kaneko (132 exposed pregnancies), found a clear but not statistically significant positive trend between dose and incidence of malformation based on 132 phenytoin-exposed pregnancies. Overall, these data are inconsistent and too limited to draw conclusions on a dose-dependent risk of congenital malformations following phenytoin exposure in utero.
Non-clinical data from studies in rats have reported developmental toxicity (embryolethality, growth retardation) in the offspring exposed to either oxcarbazepine or its active 10-hydroxy metabolite during pregnancy at doses relevant to human therapeutic doses. The largest studies are those by Christensen et al 2013 (386 children exposed to carbamazepine) and 2019 (423 children exposed to carbamazepine), which examined the risk of autism spectrum disorders and ADHD, respectively. The studies by Christensen et al and the meta-analyses do not suggest an increased risk of symptoms or diagnoses of autism spectrum disorders or ADHD following carbamazepine exposure during pregnancy. Where studies have examined effects on intelligence quotient (IQ), there are conflicting results from some of the individual studies compared with the findings of the meta-analyses.
- The largest studies are those by Christensen et al 2013 (386 children exposed to carbamazepine) and 2019 (423 children exposed to carbamazepine), which examined the risk of autism spectrum disorders and ADHD, respectively.
- As well as whether the drug is indicated for the treatment, prevention, mitigation, cure, relief, or diagnosis of that disease or condition.
- The phenomenon of true «genius» appears to come when many of these intelligences are well developed and used simultaneously.
- NICE guidance recommends that oxcarbazepine can be used first line for generalised tonic-clonic seizures and also as first line and adjunctive treatment for focal seizures.
- Some basic concepts which will help you on your journey are Learning Cycles, Learning Styles, Mind (Brain) States, Learning Rhythms, Multiple Intelligences, Competence Model, Brain Architecture, and Mind Mapping®.
Peripheral neuropathy develops when nerves in the body’s extremities, such as the hands, feet and arms, are damaged. The main symptoms of peripheral neuropathy include numbness and tingling in the feet or hands, burning stabbing or shooting pain in affected areas, loss of balance and co-ordination, and muscle weakness, especially in the feet. Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. PILs are based on the Summaries of Product Characteristics (SPCs) which are a description of a medicinal product’s properties and the conditions attached to its use. Myoclonic seizures are brief but can happen in clusters (many happening close together in time), and often happen shortly after waking. They are classified as generalised seizures because the person is likely to have other seizures as well as myoclonic seizures.
These are broadly reflected in the current product information (the Summary of Product Characteristics for healthcare professionals and the Patient Information Leaflet). With regards to risk of specific malformations, the available data suggest an increased risk of oral cleft lip or palate, hypospadias and atrial septal defect in association with topiramate. While the evidence to support an increased risk of major congenital malformations is not consistent across all studies, those that do not suggest an increased risk tend to be studies with a smaller number of pregnancies exposed to topiramate.