Luca Vignatelli- Doctor of Medicine
- Medical Doctor; Senior Researcher at Istituto delle Scienze Neurologiche di Bologna
Luca Vignatelli
- Doctor of Medicine
- Medical Doctor; Senior Researcher at Istituto delle Scienze Neurologiche di Bologna
Neurologist with focus on methodology and epidemiology
About
345
Publications
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Introduction
Neurologist with focus on epidemiology.
Methodologist with focus on systematic reviews, HTA, clinical practice guidelines and consensus conference documents.
MD (1993); Neurology (1999); Sleep Medicine PhD (2003).
Current institution
Additional affiliations
January 2007 - February 2010
February 2008 - present
October 2002 - February 2008
Publications
Publications (345)
Background and Objectives
The diagnosis of narcolepsy type 1 (NT1) currently requires the multiple sleep latency test (MSLT), or a nocturnal sleep-onset REM period (SOREMP) combined with typical cataplexy, or alternatively the determination of CSF hypocretin-1 (CSF-hcrt-1) deficiency. We evaluated the 24-hour polysomnography (PSG) recordings in adu...
Background
Epilepsy significantly impacts on morbidity and mortality. Understanding hospitalization and mortality risks in persons with epilepsy (PWE) is essential for improving healthcare strategies. We aimed to investigate the risk and causes of hospitalization and mortality in PWE compared to a matched general population cohort.
Methods
The Epi...
Objective
The STEPPER (Status Epilepticus in Emilia‐Romagna) study aimed to investigate the clinical characteristics, prognostic factors, and treatment approaches of status epilepticus (SE) in adults of the Emilia‐Romagna region (ERR), Northern Italy.
Methods
STEPPER, an observational, prospective, multicentric cohort study, was conducted across n...
Objective
Status epilepticus (SE) is the second most common neurological emergency in adults. Despite improvements in the management of acute neurological conditions over the last decade, mortality is still durably high. Because a gap has emerged between SE management based on clinical practice guidelines (CPGs) and actual clinical practice, we con...
Objective
Status epilepticus (SE) is a neurological emergency in childhood, often leading to neuronal damage and long‐term outcomes. The study aims to identify barriers in the pre‐hospital and in‐hospital management of community‐onset pediatric SE and to evaluate the effectiveness of pediatric scores on outcomes prediction.
Methods
This monocentri...
Introduction: Approximately 2 million people in Italy are currently living with dementia or mild cognitive impairment (MCI), and 4 million are involved as family members or caregivers. Considering the significant impact of dementia, the Italian Ministry of Health entrusted the Italian National Institute of Health (Istituto Superiore di Sanità) with...
Cognition-oriented treatments (COTs) are a group of non-pharmacological treatments aimed at maintaining or improving cognitive functioning. Specific recommendations on the use of these interventions in people living with dementia (PLwD) are included in the Italian Guideline on the Diagnosis and Treatment of Dementia and Mild Cognitive Impairment, d...
Introduction: Approximately 2 million people in Italy are currently living with dementia or mild cognitive impairment (MCI), and 4 million are involved as family members or caregivers. Considering the significant impact of dementia, the Italian Ministry of Health entrusted the Italian National Institute of Health (Istituto Superiore di Sanità) with...
Introduction
Lafora disease (LD) is an ultrarare fatal progressive myoclonic epilepsy, causing drug-resistant epilepsy, myoclonus and psychomotor deterioration. LD is caused by mutations in EPM2A or NHLRC1, which lead to the accumulation of polyglucosans in the brain and neurodegeneration. There are no approved treatments for LD. VAL-1221 is a fusi...
Excessive daytime sleepiness (EDS) and insomnia (IN) complaints represent the most common sleep/wake disorders. Currently, the specific needs of these patients and their relatives, as well as the overall socio-economic burden of IN and EDS remains widely unexplored. This pilot study to be carried out in Switzerland is a retro- and prospective, nati...
Narcolepsy type 1 (NT1) is a chronic neurological disorder characterized by symptoms such as excessive daytime sleepiness, sudden sleep episodes, disrupted nocturnal sleep, cataplexy, sleep paralysis, and hypnagogic hallucinations, which significantly impact the overall well-being and quality of life of individuals. While psychological factors have...
Objective: Typically diagnosed in early childhood or adolescence, TSC is a chronic, multisystemic disorder with age-dependent manifestations posing a challenge for transition and for specific surveillance throughout the lifetime. Data on the clinical features and severity of TSC in adults and on the prognosis of epilepsy are scarce. We analyzed the...
Purpose
We aim to propose a visual quantitative score for muscle edema in lower limb MRI to contribute to the diagnosis of idiopathic inflammatory myopathy (IIM).
Material and methods
We retrospectively evaluated 85 consecutive patients (mean age 57.4 ± 13.9 years; 56.5% female) with suspected IIM (muscle weakness and/or persistent hyper-CPK-emia...
To investigate potential sex-related differences in patients with narcolepsy type 1, we carried out an analysis of baseline data from 93 women and 89 men with narcolepsy type 1 who participated in the TElemedicine for NARcolepsy (TENAR) trial. The following data were considered: sociodemographics; diagnostic (disease history, polysomnography, orexi...
Introduction: Lafora Disease (LD) is an ultrarare fatal progressive myoclonic epilepsy, causing drug-resistant epilepsy, myoclonus, and psychomotor deterioration. LD is caused by mutations in EPM2A or NHLRC1, which lead to the accumulation of polyglucosans in the brain and neurodegeneration. There are no approved treatments for LD. VAL1221 is a fus...
Volumetric absorptive microsampling (VAMS) is increasingly proposed as a clinically reliable therapeutic drug monitoring (TDM) sampling methodology. The study aimed to establish the reliability and real-life feasibility of patient self-collected capillary VAMS for TDM of antiseizure medication (ASMs), using plasma ASMs concentrations from venous bl...
The most critical burden for People with Epilepsy (PwE) is represented by seizures, the unpredictability of which severely impacts quality of life. The design of real-time warning systems that can detect or even predict ictal events would enhance seizure management, leading to high benefits for PwE and their caregivers. In the past, various researc...
Background and Objectives
Narcolepsy type 1 (NT1) is still largely underdiagnosed or diagnosed too late in children. Difficulties in obtaining rapid and reliable diagnostic evaluations of the condition in clinical practice partially explain this problem. Predictors of NT1 include cataplexy and sleep-onset REM periods (SOREMPs), documented during no...
The aim of this study was to assess work productivity and activity impairments and to explore their association with excessive daytime sleepiness, body mass index (BMI), depression, and anxiety in patients with narcolepsy type 1. We carried out a cross‐sectional study in which patients with narcolepsy type 1 and matched controls for sex, age, and e...
In conclusion we would like to suggest a possible role of a direct “second” line treatment as “first” option in NORSE/FIRES cases, in order to spare time in a rare disease burdened by high rate of mortality.
Background
Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system requiring complex diagnostic and therapeutic management. Treatment with Disease Modifying Drugs (DMDs) is aimed at reducing relapse rate and disease disability. Few real-world, population-based data are available on the impact of adherence on relapse...
The proposal of combined diagnostic criteria for movement disorders
Background
Lafora disease (LD) is a fatal form of progressive myoclonic epilepsy caused by biallelic pathogenic variants in EPM2A or NHLRC1 . With a few exceptions, the influence of genetic factors on disease progression has yet to be confirmed. We present a systematic review and meta-analysis of the known pathogenic variants to identify genotype–p...
Introduction Health administrative databases are widely used for the estimation of the prevalence of Parkinson's Disease (PD). Few in general, and none used in Italy, have been validated by testing their diagnostic accuracy. The primary objective was to validate two algorithms for the identification of persons with PD using clinical diagnosis as th...
Background: Lafora disease (LD) is a fatal form of progressive myoclonic epilepsy caused by biallelic pathogenic variants in EPM2A or NHLRC1. With a few exceptions, the influence of genetic factors on disease progression has yet to be confirmed. We present a systematic review and meta-analysis of the known pathogenic variants to identify genotype-p...
Study objectives:
This study aimed to explore resilience and its possible association with sociodemographic and clinical features in patients with narcolepsy type 1 (NT1).
Methods:
Cross-sectional study involving patients with NT1 and age/sex-matched controls (comparison group). Sociodemographic and clinical data were collected through semi-stru...
In Italy, prevalence estimates of Parkinson's Disease show high variability and range from 0.6 to 6.2 cases per 1,000 inhabitants. The estimate found in the territory of the Local Health Trust of Bologna (4.3 per 1,000 inhabitants, 95% CI 4.2-4.4) is at the higher end of this range. This figure confirms the need to consider this disease, which burd...
Status epilepticus (SE) is a neurological emergency characterized by high mortality that has remained stable across decades. This stability could be partly explained by general aging of population but also by the gap between management based on clinical practice guidelines (CPGs) and clinical practice. CPGs for management of SE have been available...
Objective
To investigate adolescents’ and parents’ preferences concerning information on narcolepsy.
Methods
During a one-year cross-sectional study, adolescents (12–20 years old) with narcolepsy and parents attending the Narcolepsy Center of Bologna (Italy) were invited to fill in a questionnaire including 28 pieces of information regarding narco...
Background:
The development of high-quality clinical practice guidelines (CPGs) takes substantial time, efforts and resources. During the last years, the EAN guideline production was significantly increased, so the need of development of clear, transparent, and methodologically solid criteria for prioritizing guideline topics became apparent. With...
Background
Ataxia is a rare neurological condition causing a deficit in the coordination of motor activities, preventing the fluidity of movements. Children with ataxia may show several different ataxic signs, along with difficulties in walking autonomously and ataxic gait often associated with trunk instability. Ataxic signs can be either acute or...
Study objectives
Narcolepsy is a rare chronic central disorder of hypersomnolence with frequent endocrine-metabolic comorbidities. To address the complex care needs of patients during the COVID-19 emergency, we carried out a feasibility study of the TElemedicine for NARcolepsy (TENAR) protocol with the aim of assessing the feasibility of a multidis...
The Unified Multiple System Atrophy (MSA) Rating Scale was developed to provide a surrogate marker of disease severity and clinical progression in patients with MSA. It is comprised of four subscales: UMSARS-I (12 items) rates patient-reported functional disability; UMSARS-II (14 items) assesses motor impairment based on a clinical examination; UMS...
Oltre agli effetti diretti dell’infezione, la pandemia di COVID-19 ha prodotto, attraverso le drastiche misure di restrizione e distanziamento attuate soprattutto nel primo anno, un impatto su molti determinanti della salute quali i fattori sociali, i fattori economici, i fattori ambientali, i comportamenti individuali e l’accessibilità ai servizi...
Objective
Data on COVID‐19 outcomes in persons with epilepsy (PWE) are scarce and inconclusive. We aimed to study the risk of hospitalization and death for COVID‐19 in a large cohort of PWE from March 1, 2020 to October 31, 2021.
Methods
The historical cohort design (EpiLink Bologna) compared adult PWE grouped into people with focal epilepsy (PFE)...
Background:
The patterns of long term risk of SARS-CoV-2 infection, hospitalization for COVID-19 and related death are uncertain in people with Parkinson's disease (PD) or parkinsonism (PS). The aim of the study was to quantify these risks compared to a control population cohort, during the period March 2020-May 2021, in Bologna, northern Italy....
Aim: Feasibility of repeated TELEVISITS for people with narcolepsy during 1 year of COVID-19 pandemic in Italy
AIM: To study the risk of hospitalization and death for COVID 19 in a large cohort of PWE from 01 March 2020 to 30 October 2021.
Introduction:
Amyotrophic lateral sclerosis is a fatal progressive disease with a still unclear multi-factorial etiology. This study focused on the potential relationship between drug exposure and the development of amyotrophic lateral sclerosis by performing a detailed analysis of events reported in the FDA Adverse Event Reporting System database...
Background
The indirect impact of the COVID-19 epidemic on major clinical outcomes of people with Parkinson's disease (PD) or other parkinsonism is unknown.
Objectives
The study aimed to (1) describe changes in healthcare services during the first epidemic bout in people with PD or parkinsonism; (2) compare the occurrence of hospitalization for an...
Background:
The second consensus criteria for the diagnosis of multiple system atrophy (MSA) are widely recognized as the reference standard for clinical research, but lack sensitivity to diagnose the disease at early stages.
Objective:
To develop novel Movement Disorder Society (MDS) criteria for MSA diagnosis using an evidence-based and consen...
Objective
To evaluate the long-term outcome of patients with epilepsy and malformations of cortical development (MCD).
Methods
We conducted a historical cohort study of patients with epilepsy and MCD due to impaired neuronal migration and postmigration organization, and with a follow-up period of ≥5 years. For each patient, MCD was classified afte...
Objective
To identify predisposing factors for hyperkinetic seizure occurrence in a representative cohort of surgically treated patients with drug-resistant focal epilepsy.
Methods
We retrospectively recruited all seizure-free patients after epilepsy surgery with a postoperative follow-up ≥12 months. Patients were classified as presenting with hyp...
Background and purpose:
Rare diseases affect up to 29 million people in the European Union, and almost 50% of them affect the nervous system or muscles. Delays in diagnosis and treatment onset and insufficient treatment choices are common. Clinical practice guidelines (CPGs) may improve the diagnosis and treatment of patients and optimize care pat...
Dopo due anni di pandemia di COVID-19 possono essere posti alcuni punti fermi sulle relazioni tra l’infezione e la malattia di Parkinson.
The purpose of this protocol is to report the rationale and methodology of a systematic review of clinical practice guidelines on the diagnostic and therapeutic management of status epilepticus in adults.
The aims of this systematic review will be to 1) appraise the quality
of clinical practice guidelines, assuming that the Applicability domain may...
La presente Linea guida (LG) nasce da un progetto di rete finanziato dal Ministero
della salute nell’ambito dei progetti di ricerca finalizzata, allo scopo di migliorare la
gestione globale delle Atassie pediatriche (AP).
I segni atassici in età pediatrica possono presentarsi in forme e livelli di gravità
molto eterogenei e possono essere dovuti a...
INTRODUZIONE Durante il primo lockdown (marzo-maggio 2020), l'AUSL di Bologna (bacino di utenza c. 900.000 persone) ha ridotto l'erogazione di servizi sanitari anche a pazienti con patologie croniche, con possibili conseguenze sulla salute. La malattia di Parkinson (MdP) e i parkinsonismi (PKS) sono due condizioni di vulnerabilità estrema, e nell'A...
Background
Lafora disease (LD) is a rare fatal autosomal recessive form of progressive myoclonus epilepsy. It affects previously healthy children or adolescents, causing pharmacoresistant epilepsy, myoclonus and severe psychomotor deterioration. This work aims to describe the clinical course of LD and identify predictors of outcome by means of a pr...
Introduction
Epilepsy is a chronic condition requiring consistent follow-up aimed at seizure control, and monitoring of anti-seizure medication (ASM) levels and side effects. Telemedicine (TM) offers invaluable support to patient follow-up, guaranteeing the prompt availability of a team of experts for persons with epilepsy (PWE) widely distributed...
Redatto il 10 ottobre 2021 a conclusione del webinar della “Giornata nazionale dei risvegli per la ricerca sul coma - vale la pena” promossa da Gli amici di Luca sotto l’Alto Patronato del Presidente della Repubblica. Nel presente documento le persone in coma, Stato Vegetativo e di Minima Coscienza sono persone che presentano gravissima disabilità...
INTRODUZIONE
Il rischio di ospedalizzazione da Sars-Cov-2 sembra più elevato in popolazioni vulnerabili (ad esempio patologie croniche). Non è chiaro se questi rischi siano rimasti costanti durante tutto il periodo epidemico.
OBIETTIVI
Valutare il rischio di ospedalizzazione da Sars-Cov-2 e relativa mortalità in una coorte di pazienti con Malattia...
EAN narcolepsy guideline INFOGRAFHIC
Introduction
: Data on seizure course during pregnancy in women with epilepsy are limited. In particular, little is known about the causes underlying possible seizure worsening in this population. We therefore set out to explore worsening, in pregnancy, of sleep-related hypermotor epilepsy (SHE), a syndrome in which seizures are known to be trigger...
Objective: To describe the clinical course of Lafora Disease (LD) and identify predictors of outcome by means of a prognostic systematic review with individual participant data meta-analysis.
Methods: A search was conducted on MEDLINE and Embase with no restrictions on publication date. Only studies reporting genetically confirmed LD cases were inc...
During the first 7 months of epidemic bout of COVID-19, including 3 months of strict social lockdown measures and drastic healthcare organizations followed by 4 months of gradual recovery, we observed a harsh restriction of all scheduled healthcare provisions in a population based cohort of Parkinson's disease and parkinsonism of a province of Nort...
Protocol of systematic review (PROSPERO database, CRD42020190877)
Background
Depression is more frequently associated with akinetic-rigid/postural instability gait difficulty subtypes of Parkinson's disease than with tremor-dominant subtype.
Objectives
The aim of the study is to investigate the frequency of exposure to antidepressant drugs, as proxy of depression, before motor onset according to Parkinson's dise...
Background and purpose
Narcolepsy is an uncommon hypothalamic disorder of presumed autoimmune origin that usually requires lifelong treatment. This paper aims to provide evidence-based guidelines for the management of narcolepsy in both adults and children.
Methods
The European Academy of Neurology (EAN), European Sleep Research Society (ESRS), an...
Background and aim
Narcolepsy is an uncommon hypothalamic disorder of presumed autoimmune origin that usually requires lifelong treatment. This paper aims to provide evidence-based guidelines for the management of narcolepsy in both adults and children.
Methods
The European Academy of Neurology (EAN), European Sleep Research Society (ESRS) and Eur...
Clinical guidelines are "statements that include recommendations, intended to optimize patient care, that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options".1 Clinical guidelines are increasingly becoming a part of neurology clinical practice, most probably because they may impro...
Introduction:
Known risk factors for multiple sclerosis (MS) include smoking, a low vitamin D status, obesity, and EBV, while the inflammatory feature of the disease strongly suggests the presence of additional infectious agents. The association between use of antibiotics and MS risk that could shed light on these factors is still undetermined. We...
Multiple system atrophy (MSA) is a neurodegenerative disorder characterized by a combination of autonomic failure plus cerebellar syndrome and/or parkinsonism. Dysphagia is a frequent and disabling symptom in MSA and its occurrence within 5 years of motor onset is an additional diagnostic feature. Dysphagia can lead to aspiration pneumonia, a recog...
Background:
Neuroimaging has been used to support a diagnosis of possible multiple system atrophy (MSA). Only blood pressure changes upon standing are included in the second consensus criteria but other autonomic function tests (AFT) are also useful to diagnose widespread and progressive autonomic failure typical of MSA. Additional diagnostic tool...
Background
Arousal Disorders (DoA) include Confusional Arousals, Sleepwalking and Sleep Terrors. DoA diagnosis is mainly clinical but no validated questionnaires exist for DoA screening according to the criteria of the International Classification of Sleep Disorders, Third Edition. Recently our group proposed the Arousal Disorders Questionnaire (AD...
Paediatric Type 1 Narcolepsy (NT1) is often associated with overweight and obesity. Sodium oxybate (SO), approved for the treatment of narcolepsy with cataplexy from the age of 7 years old in US, has been associated with weight loss, although longitudinal paediatric studies are lacking. We report a retrospective cohort of 129 consecutive patients w...
Continuano ad essere in primo piano, purtroppo, le tematiche relative all'infezione da COVID-19. Questo mese segnaliamo un lavoro appena apparso sulla rivista Movement Disorders (Mov Disord. 2020 Nov 16. doi:10.1002/mds.28408), condotto, fra gli altri, da colleghi dell'IRCCS-Istituto delle Scienze Neurologiche di Bologna (ISNB) e del nostro Diparti...
Objectives: We explored the impact of the coronavirus disease-19 (COVID-19) emergency on the health of people with epilepsy (PwE). We also investigated their attitude toward telemedicine.
Methods: The PubMed database up to September 10, 2020 was searched for questionnaire-based studies conducted in PwE during the COVID-19 emergency, and the literat...
During the lockdown period Parkinson’s d./parkinsonism vs controls had increased risk of
• Urgent hospital admissions
• Major clinical disesease specific outcomes
Parkinson's disease per-se probably is not a risk factor for COVID-19 hospitalization. Conversely, parkinsonism is an independent risk factor probably due to a more severe health status, entailing a higher care dependency and the placement in high infection risk accommodations. This article is protected by copyright
Study Objectives
Narcolepsy type 1 (NT1) is a chronic rare hypersomnia of central origin requiring a combination of behavioral and pharmacological treatments. During the coronavirus disease 2019 (COVID‐19) pandemic, in Italy the population was forced into a lockdown. With this study, we aimed to describe the lockdown impact on NT1 symptom managemen...
Questions
Questions (5)
The objective is to describe the health profile of a general population sample regarding the most common noncommunicable diseases, without the help of health professionals.
A randomized controlled trial with withdrawal design (Randomized Withdrawal Studies according to the FDA definition, "Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products Guidance for Industry", March 2019) involves patients who have an apparent response to treatment in an open-label period and thar are randomized to continued drug treatment or to placebo treatment. Because such trials generally involve only patients who appear to have responded, this is a study including only responders at baseline. This is design suggested by FDA as enrichment strategy to support determination of effectiveness of drugs.
Should this strategy be considered as a source of selection bias, and thus should this kind of RCT be downgraded according to the GRADE method?
I have recently seen a 78-yr-old male that developed a treatment-resistant insomnia (bdz, trazodone, neuroleptics, melatonin) soon after the start of apixaban therapy for DVT.
Has anyone seen similar cases? Solutions?
thanks
Luca
Please forgive me. This is not research-related question however it deals with a researcher of our community. Please follow him https://www.researchgate.net/profile/Ahmadreza_Djalali and ask of him in your own country. Reference https://www.amnesty.org/en/documents/mde13/5632/2017/en/
I have visited an 29-year old man from Mali with signs of lower motoneurons (bulbar, upper limbs), resembling ALS. He travelled for 8 months from Mali to Italy in extremely hard conditions. Does someone know whether there are some toxic or infectious agents that can mimic ALS?
Thank You
