Status:
UNKNOWN
Bulimia Nervosa and Binge Eating Disorder: Comparing Therapeutic Strategies
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Bulimia Nervosa
Binge-Eating Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
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 e...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05296915
Start Date
January 1 2022
End Date
August 31 2024
Last Update
April 22 2022
Active Locations (1)
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1
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, Italy, 20100