Bulimia Nervosa e Binge Eating Disorder: Strategie Terapeutiche a Confronto
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Changing in dietary behaviour in terms of changes in Eating Disorder Examination scale score at T3
Study Overview
Brief Summary
This study aims to assess the effectiveness of new neurostimulation techniques in patients with eating disorders.
The primary aim of our proposal is to test a reduction in symptoms of alteration of eating behaviors, such as always thinking about food or binge eating, in a sample of 30 patients, aged between 18 and 65, with diagnosis of Bulimia Nervosa or Binge Eating Disorder. Of these patients, 10 will undergo to a protocol of vagal transcutaneous stimulation in the ear (tVNS) and targeted cognitive-behavioral therapy (CBT-E), another 10 to a protocol of transcranial magnetic stimulation (rtms) and CBT-E and another 10 to a protocol of only tergeted CBT-E, comparing the results obtained in the three groups under study. Secondary purposes of this project are the assessment of the effects of auricular vagal transcutaneous stimulation and of transcranial magnetic stimulation on depressive symptoms associated with eating disorder, on the inflammatory profile, on cardiovascular autonomic control, neuronal excitability, functional connectivity and on the quality of life of these patients.
In order to achieve the objectives of this research project, we will perform a national, interventional on a medical device, monocentric study, controlled in 3 parallel and randomized groups with a 1:1:1 allocation ratio. 30 patients will be recruited at the Day Hospital of the Psychiatry Unit of the Fondazione.
Detailed Description
This study aims to assess the effectiveness of new neurostimulation techniques in patients with eating disorders.
To date, the management of these disorders is still difficult and few treatments have proven their effectiveness. According to most guidelines, management is typically multidisciplinary. The best validated and most frequently used treatment is the cognitive behavioral therapy enanched (CBT-E), a highly individualized psychological treatment designed to treat all diagnostic categories of eating disorders, addressing the common cognitive-behavioural mechanisms of maintaining shared and evolving psychopathology of eating disorders.
For Bulimia Nervosa (BN) and Binge Eating Disorder (BED), the serotoninergic antidepressants are the most frequently used pharmacological option (considering the frequent recurrence of depressive symptoms in comorbidity in the clinical population with eating disorders), which may improve symptoms in the medium term, but not allow complete remission. In this context, the development of alternative therapeutic strategies is crucial. Recently, several studies have described the important contribution of neurostimulation techniques (such as repetitive transcranial magnetic stimulation (rTMS), and vagal nerve stimulation (VNS)). Following the proven effectiveness, both rTMS and VNS have received official approval for the treatment of depression in Europe and United States. Neuroimaging studies have revealed that both of these neurostimulation techniques modulate the frontal-vagal network, the one with a top-down mechanism (rTMS) and the other with a bottom-up mechanism (VNS).
The neuromodulation influencing the functioning of the central nervous system (CNS) and the emotional/alimentary behavior, would offer an alternative (or complementary) intervention to psychotropic drugs and different psychological and nutritional approaches. Studies in the literature, conducted on patients with BN and BED, showed a significant improvement in symptomatology, in terms of "binge eating", after rTMS stimulation of the left dorsolateral prefrontal cortex (DLPFC). Instead, the effectiveness of vagal stimulation in the treatment of ED lies in the fact that the vagus nerve plays a fundamental role in mood and appetite regulation. Human studies report how tVNS stimulation produces a reduction in the effect of food cravings. Moreover, currently, in patients with ED, the determined effects of vagal non-invasive neurostimulation have not been compared with the effects of repetitive transcranial magnetic stimulation.
Therefore, the primary aim of our proposal is to test a reduction in symptoms of alteration of eating behaviors, such as always thinking about food or binge eating, in a sample of 30 patients, aged between 18 and 65, with diagnosis of Bulimia Nervosa or Binge Eating Disorder, according to the diagnostic criteria of DSM-V, and with a psychopathological framework of depression in comorbidity (cut-off ≥ 8 of the Hamilton Depression Rating Scale, HAM-D). Of these patients, 10 will undergo to a protocol of vagal transcutaneous stimulation in the ear (tVNS) and targeted cognitive-behavioral therapy (CBT-E), another 10 to a protocol of transcranial magnetic stimulation (rtms) and targeted cognitive-behavioral therapy (CBT-E) and another 10 to a protocol of only tergeted cognitive-behavioral therapy (CBT-E), comparing the results obtained in the three groups under study. Secondary purposes of this project are the assessment of the effects of auricular vagal transcutaneous stimulation and of transcranial magnetic stimulation on depressive symptoms associated with eating disorder, on the inflammatory profile, on cardiovascular autonomic control, neuronal excitability, functional connectivity and on the quality of life of these patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
Personnel responsible for HRV analysis and determination of inflammatory biomarker levels will be blinded.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients diagnosed with Bulimia Nervosa or Binge Eating Disorder, according to the diagnostic criteria of DSM-V, with a psychopathological framework of depression in comorbidity (cut-off ≥ 8 of the Hamilton Depression Rating Scale, HAM-D), aged between 18 and 65 years.
Exclusion Criteria
- •Previous TMS sessions with significant side effects;
- •Conditions leading to an increased risk of epilepsy or side effects in the context of transcranial magnetic stimulation (including personal or family history of epilepsy, cerebral ischemic events, neurological pathologies, neurosurgical interventions, orthopedic or vascular interventions in the head-neck district, major head trauma, migraine or severe headache);
- •Presence of pacemakers, defibrillators, infusion pumps, neurostimulation implants (DBS, VNS), endovascular implants in the head-neck district, cochlear implants, cerebrospinal shunts, metal implants in the head-neck area ;
- •Exposure to penetration of metal chips in the head-neck area;
- •Presence of non-removable metal in the head-neck area (including tattoos, permanent make-up, piercing, excluding dental implants);
- •Unstable sinus rhythm at ECG (Pace-Maker rhythm, atrial fibrillation, supra-/ventricular extrasystole);
- •Chronic intake of β-blocker;
- •Heart, respiratory, renal or hepatic failure and immunosuppression;
- •Current hospitalization;
- •State of pregnancy or lactation;
- •Vestibular or balance problems;
- •Positive personal history of schizophrenia or schizoaffective disorder;
- •Substance or alcohol abuse in the last 6 months;
- •Positive personal history of intellectual disability ("mental retardation");
- •Refusal of informed consent by the patient.
Arms & Interventions
tVNS + CBT-E group
N=10 Interventional group with transcutaneous stimulation of the auricular branch of the vagus nerve associated with targeted cognitive-behavioral therapy (following the CBT-E protocol, CG Fairburn - 2010.
Intervention: CBT-E (Behavioral)
tVNS + CBT-E group
N=10 Interventional group with transcutaneous stimulation of the auricular branch of the vagus nerve associated with targeted cognitive-behavioral therapy (following the CBT-E protocol, CG Fairburn - 2010.
Intervention: tVNS (Device)
rTMS + CBT-E group
N=10 Interventional group with repetitive transcranial magnetic stimulation associated with targeted cognitive-behavioral therapy (following the CBT-E protocol, CG Fairburn - 2010.).
Intervention: rTMS (Device)
rTMS + CBT-E group
N=10 Interventional group with repetitive transcranial magnetic stimulation associated with targeted cognitive-behavioral therapy (following the CBT-E protocol, CG Fairburn - 2010.).
Intervention: CBT-E (Behavioral)
Only CBT-E group
N=10 Group with only cognitive-behavioral therapy of eating disorders.
Intervention: CBT-E (Behavioral)
Outcomes
Primary Outcomes
Changing in dietary behaviour in terms of changes in Eating Disorder Examination scale score at T3
Time Frame: 6 months from the start of treatment
Effectiveness in changing dietary behaviour in terms of the EDE (Eating Disorder Examination) score difference between groups at T3. Great differences mean better clinical outcome.
Secondary Outcomes
- Incidence of acute effects of treatments in terms of difference between pre- and post-treatment(After 12 weeks of stimulation (T2))
- Incidence of long-term effects in terms of relapses and difference between T0 and T4.(After 12 months (T4) from enrollment)
- Incidence of acute effects of treatments in terms of difference between pre- and post-treatment(After 4 weeks of stimulation (T1))