Background: Cerebral cavernous malformations (CCMs) are vascular malformations characterized by clusters of enlarged leaky capillaries in the central nervous system. They may result in intracranial haemorrhage, epileptic seizure(s), or focal neurological deficits, and potentially lead to severe disability. Globally, CCMs represent the second most common intracranial vascular malformation in humans, and their familial form (FCCMs) accounts for one-fifth of cases. Neurosurgical excision, and perhaps stereotactic radiosurgery, is the only available therapeutic option. Case reports suggest that propranolol might modify disease progression. Methods: Treat_CCM is a prospective, randomized, open-label, blinded endpoint (PROBE), parallel-group trial involving six Italian clinical centres with central reading of brain magnetic resonance imaging (MRI) and adverse events. Patients with symptomatic FCCMs are randomized (2:1 ratio) either to propranolol (40-80 mg twice daily) in addition to standard care or to standard care alone (i.e. anti-epileptic drugs or headache treatments). The primary outcome is intracranial haemorrhage or focal neurological deficit attributable to CCMs. The secondary outcomes are MRI changes over time (i.e. de novo CCM lesions, CCM size and signal characteristics, iron deposition, and vascular leakage as assessed by quantitative susceptibility mapping and dynamic contrast enhanced permeability), disability, health-related quality of life, depression severity, and anxiety (SF-36, BDI-II, State-Trait Anxiety Inventory). Discussion: Treat_CCM will evaluate the safety and efficacy of propranolol for CCMs following promising case reports in a randomized controlled trial. The direction of effect on the primary outcome and the consistency of effects on the secondary outcomes (even if none of them yield statistically significant differences) of this external pilot study may lead to a larger sample size in a definitive phase 2 trial. Trial registration: ClinicalTrails.gov, NCT03589014. Retrospectively registered on 17 July 2018.
Semantic verbal fluency test is frequently used in clinical practice to assess lexical retrieval and production in neurological and psychiatric diseases. Semantic category is a crucial variable to consider in patients with language disorders. Norms for this task were collected from a population of 290 Italian healthy participants with age ranging from 18 to 98 years. The aim was to provide normative data both for the global score and for each semantic category (animals, fruits, brands of cars). Multiple regression analysis revealed that age and education significantly correlated with the global score and with single semantic categories. In particular, increasing age negatively affected performance, whereas the performance increased with a higher education. Statistically significant differences between men and women were found only for brands of cars. The availability of equivalent scores for the single semantic categories will prove useful in clinical practice since it allows the comparison of single semantic categories in patients with language disorders.
Data for copying and delayed recall (after a 15-min delay) of the Modified Taylor Complex Figure (MTCF), an alternative form of the Rey-Osterrieth Complex Figure (ROCF), were collected from 290 healthy participants. Normative data are provided. Age and education were significantly correlated with MTCF scores and must be corrected for to interpret results accurately. More specifically, increasing age adversely affected performance, whereas a higher education resulted in a better performance. Twenty-five participants were tested with both complex figures (MTCF and ROCF) in two separate sessions to assess correlation, which proved to be high. The collected data allow using the MTCF as a valid alternative material for testing visual long-term memory avoiding implicit learning that can occur when the same version of the ROCF is used for repeated testing sessions.
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