Bulimia Nervosa and Binge Eating Disorder: Comparing Therapeutic Strategies
Bulimia Nervosa, Binge-Eating Disorder
About this trial
This is an interventional treatment trial for Bulimia Nervosa focused on measuring Bulimia Nervosa, Eating disorders, rTMS, CBT-E, tVNS, EEG
Eligibility Criteria
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.
Sites / Locations
- Fondazione IRCCS Ca' Granda - Ospedale Maggiore PoliclinicoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
tVNS + CBT-E group
rTMS + CBT-E group
Only 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.
N=10 Interventional group with repetitive transcranial magnetic stimulation associated with targeted cognitive-behavioral therapy (following the CBT-E protocol, CG Fairburn - 2010.).
N=10 Group with only cognitive-behavioral therapy of eating disorders.