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Trans-Auricular Vagus Nerve Stimulation in The Psychiatria Danubina, 2020; Vol. 32, Suppl. 1, pp 42-46 Conference paper © Medicinska naklada - Zagreb, Croatia TRANS-AURICULAR VAGUS NERVE STIMULATION IN THE TREATMENT OF RECOVERED PATIENTS AFFECTED BY EATING AND FEEDING DISORDERS AND THEIR COMORBIDITIES Yuri Melis1,2, Emanuela Apicella1,2, Marsia Macario1,2, Eugenia Dozio1, Giuseppina Bentivoglio2 & Leonardo Mendolicchio1,2 1Villa Miralago, Therapeutic Community for Eating Disorders, Cuasso al Monte, Italy 2Food for Mind Innovation Hub: Research Center for Eating Disorders, Cuasso al Monte, Italy SUMMARY Introduction: Eating and feeding disorders (EFD’s) represent the psychiatric pathology with the highest mortality rate and one of the major disorders with the highest psychiatric and clinical comorbidity. The vagus nerve represents one of the main components of the sympathetic and parasympathetic nervous system and is involved in important neurophysiological functions. Previous studies have shown that vagal nerve stimulation is effective in the treatment of resistant major depression, epilepsy and anxiety disorders. In EFD’s there are a spectrum of symptoms which with Transcutaneous auricular Vagus Nerve Stimulation (Ta-VNS) therapy could have a therapeutic efficacy. Subjects and methods: Sample subjects is composed by 15 female subjects aged 18-51. Admitted to a psychiatry community having diagnosed in according to DSM-5: anorexia nervosa (AN) (N=9), bulimia nervosa (BN) (N=5), binge eating disorder (BED) (N=1). Psychiatric comorbidities: bipolar disorder type 1 (N=4), bipolar disorder type 2 (N=6), border line disorder (N=5). The protocol included 9 weeks of Ta-VNS stimulation at a frequency of 1.5-3.5 mA for 4 hours per day. The variables detected in four different times (t0, t1, t2, t3, t4) are the following: Heart Rate Variability (HRV), Hamilton Depression Rating Scale (HAMD-HDRS- 17), Body Mass Index (BMI), Beck Anxiety Index (BAI). Results: Data analysis showed statistically significant differences between recording times (p>0.05) in HAM-D (t0=18.28±5.31; t4=9.14±7.15), in BAI (t0=24.7±10.99; t4=13.8±7.0) the reported values show how during (T0-T4) the treatment there are a decay of the degree in the depressive state, in the state of anxiety and an improvement in the value of BMI. In particular, the BMI in the AN-BN sub-sample had a minimum gain of 5% and a maximum of 11%. The analysis of H.R.V. did not show a significant changes among subjects thus confirming the discordance of the activity of the sympathetic and parasympathetic nervous system in EFD’s. Conclusions: Although the sample does not possess a relevant value to determine long-term efficacy of Ta-VNS or on a larger number of patients, this study reports how the application of neuro-stimulation in EFD’s may become an ADD-ON in therapeutic approach. Indeed, substantial improvements are highlighted in the results and confirmed hypotheses proposed by the study. Key words: anorexia nervosa - bulimia nervosa – neurostimulation - eating disorders – anxiety - depression * * * * * INTRODUCTION represent the psychiatric pathology with the highest rate of suicidal death and related pathologies. These types of Eating and feeding disorder’s (EFD’s) in according psychopathologies have a deep root in human history, in with the Diagnostic and statistical manual of mental particular in the history of the female gender. In fact, disorders (DSM-5) divides the diagnostic groups in: eating disorders have always a typically female con- anorexia nervosa (AN) disorder characterized by a notation, starting from ancient Greece, to the Roman recurrent reduction in caloric intake, loss of weight, Empire, until the late Middle Ages where we can find obsessive fear of weight gain, dysmorphophobia, biographical traces of subjects who use this behaviours egosyntonic with the disease and the denial of related to represent an ascetic life, but today this behaviours, disorders, a body mass index below 16-16.99 kg/m2; we could identify them within a psychopathological bulimia nervosa (BN) characterized by episodes of classification (Bell 1987). Certainly, Richard Morton's binge-eating where subjects consume an excessive contribution in 1689, he diagnosed for the first time in amount of food in a limited period of time, subsequently the history of medicine a EFD’s in a patient who implementing compensatory behaviours to try to contain showed how these behaviours are based on states of the fear of weight gain, such as use: of laxatives, psychological alteration (Martin 2004). The scientific induction of vomiting, phisical exercise in an obsessive- literature and the phenomenological construction of the compulsive way; binge-eating disorder (BED) beha- EFD’s, in particular of the AN, was defined by Ernest viour characterized by constant episodes over time of Charles Lasègue in France and W.W. Gull in Britain. food, but episode of binge eating without compensatory The two physician report in the article "Anorexie methods, this diagnostic category was also identified as histérique" 8 clinical cases from the prodromal stages to psychogenic obesity.(American Psychiatric Association the most advanced stages of the pathology, it is 2014). The EFD’s in particular anorexia nervosa interesting how the two physician highlighted the same S42 Yuri Melis, Emanuela Apicella, Marsia Macario, Eugenia Dozio, Giuseppina Bentivoglio & Leonardo Mendolicchio: TRANS-AURICULAR VAGUS NERVE STIMULATION IN THE TREATMENT OF RECOVERED PATIENTS AFFECTED BY EATING AND FEEDING DISORDERS AND THEIR COMORBIDITIES Psychiatria Danubina, 2020; Vol. 32, Suppl. 1, pp 42-46 connotations of the contemporary clinical-symptomatic shown how invasive vagal nerve stimulation (VNS) construct of AN (Martin 2004). The large presence in produces results on eating behaviours, thus supporting the history of these disorders underlines and confirms the hypothesis proposed by us. Human studies, report their expanding epidemiological significance. In Eu- how Ta-VNS have a reduction in food-craving effect, rope, the rates of women with EFD’s are: AN 1-4%, probably because vagal innervation engages the limbic BN1-2%, BED 1-4% of the general population; In the and dopaminergic areas of pleasure and appetite regu- USA. about 20 million women and 10 million men lation (Val-Laillet et al. 2015). Further studies converge suffer from nutrition and nutrition disorders (Keski- on the efficacy of Ta-VNS where it is reported how its Rahkonen 2016). The latest epidemiological studies for use increases the levels of G.A.B.A. and norepinephrine Italy indicate that in the female population the in the brain, thus confirming its neuro-modulatory frequency of presence is about 0.3-0.5% (one case for action of some target areas involved in EFD’s (Steen- 200-300 people) for anorexia nervosa and 1-2% (one bergen et al. 2015). Our hypothesis therefore moves on case per 50-100 people) for bulimia nervosa. The a double asset, by the stimulation of the vagus nerve constant missing data is that of the submerged data, that trans auricularly without any kind of invasiveness, we is, the subjects who are not diagnosed by the health are going to modulate the activity connected to the areas systems, thus remaining outside of the epidemiological responsible for regulating mood and in the areas of investigations without being able to demonstrate the regulation of nutrition (Bodenlos et al. 2007). Not least, magnitude of these pathologies (Udo & Grilo 2018). we took into account the fundamental action that the The other relevant trend in this pathologies, is that, in vagus nerve implements on the regulation of the auto- the last 20 years the distribution of gender: women has nomic system in areas and organs of the sympathetic changed for the EFD’s, changing from the previous ratio and parasympathetic nervous systems, two essential of 1: 10-1:15 to 1: 4. This data suggests to us how these systems in the regulation of hemogenic expressions, pathologies no longer exclude the male gender, also maintenance body homeostasis and vegetative functions highlighting the subtypes of the DAN such as vigorexia (Kong et al. 2018). and orthorexia (Strother et al. 2012). Thus, even the age of onset during the past 20 years has changed, lowering SUBJECTS AND METHODS the age of onset from adolescence or late adolescence to the pre-pubertal stages (Preti et al. 2009). The The participants involved in this study are subjects EFD’s as reported in the literature (Griton & Konsman suffering from EFD’s, patients hospitalized at "Villa 2018) they have a comorbidity with other psychiatric Miralago" center for the treatment of eating disorders in disorders such as (Godart et al. 2007) mood disorders Cuasso al Monte (VA). 15 volunteer patients from 19 to in BN subjects with values between 24.1-90%, in the 51 years of age were recruited, they read and signed the AN 31-88% (Jordan et al. 2014). informed consent. The exclusion criteria applied: heart The hypothesis we developed on the treatment of problems such as bradycardia or hypotension, no cardiac EFD’s with trans-cutaneous electrical stimulation of the implant and no other neuro-stimulation implant, no vagus nerve (Ta-VNS) has moved from the previous changes during trial of psycho-drug therapy. The sub- work of its application in the major depressive disorder jects involved in the study following the diagnostical and in refractory epilepsy (Kong et al. 2018) and in criteria in accordance with DSM-5: AN (N=9); BN obesity, where this treatment has had positive medium- (N=5), binge eating disorder (BED) (N=1) with psychia- term post-treatment results (Brunoni et al. 2010). The tric comorbidities: bipolar disorder type 1 (N=4), vagus nerve, the tenth cranial nerve plays a fundamental bipolar disorder type 2 (N=6), border line disorder role in regulating mood and regulating appetite (N=5). The device used for the Ta-VNS is the NEMOS (Bodenlos et al.
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