Bulimia Nervosa and Binge Eating Disorder: Comparing Therapeutic Strategies

NCT05296915 | Unknown

• 1 other identifier: DIGEST
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bulimia Nervosa; Binge-Eating Disorder

Keywords

Bulimia Nervosa; Eating disorders; rTMS; CBT-E; tVNS; EEG

Outcome Measures

Primary Outcomes (1)

• Changing in dietary behaviour in terms of changes in Eating Disorder Examination scale score at T3

  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.

  6 months from the start of treatment

Secondary Outcomes (3)

• Incidence of acute effects of treatments in terms of difference between pre- and post-treatment

  After 4 weeks of stimulation (T1)

• 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

Study Arms (3)

tVNS + CBT-E group

EXPERIMENTAL

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.

Device: tVNS; Behavioral: CBT-E

rTMS + CBT-E group

EXPERIMENTAL

N=10 Interventional group with repetitive transcranial magnetic stimulation associated with targeted cognitive-behavioral therapy (following the CBT-E protocol, CG Fairburn - 2010.).

Device: rTMS; Behavioral: CBT-E

Only CBT-E group

EXPERIMENTAL

N=10 Group with only cognitive-behavioral therapy of eating disorders.

Behavioral: CBT-E

Interventions

tVNS DEVICE

An electric current with a frequency of 25 Hz (Figure 2) will be applied to the cymba conca of the left ear through a specific device (VITOS, Cerbomed, Germany; CE marking). The stimulation intensity will be customized between 0.1 and 5 mA according to the sensitivity threshold of each participant. Patients will be instructed to perform tVNS at home for 4 non-consecutive hours per day for 12 weeks, in accordance with the protocol reported in the literature for the treatment of major depression.

Also known as: Transcutaneous stimulation of the auricular branch of the vagus nerve associated

tVNS + CBT-E group

rTMS DEVICE

The stimulation will be carried out with a TMS STM9000 system (Ates, Medica Device s.r.l., Italy) equipped with a 70 mm "butterfly" cooled coil. The stimulation protocol followed will be the one approved by the FDA for major depression, that is, a stimulation at the level of the left dorsolateral prefrontal cortex at an intensity equal to 120% of the motor threshold, at the frequency of 10hz. Each stimulation session will last 37.5 minutes, and will consist of 75 trains lasting 4 seconds, with a 26-second break between each train. During each session, a total of 3000 stimuli will be administered. The sessions will take place 5 days a week, from Monday to Friday, for 4 weeks, and for a total of 20 sessions of stimulation.

Also known as: Repetitive transcranial magnetic stimulation

rTMS + CBT-E group

CBT-E BEHAVIORAL

Targeted cognitive-behavioral therapy following the CBT-E protocol (CG Fairburn - 2010. La terapia cognitivo-comportamentale dei disturbi dell'alimentazione. Firenze, Eclipsi; 2010.)

Also known as: Cognitive-behavioral therapy - enanched

Only CBT-E group; rTMS + CBT-E group; tVNS + CBT-E group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, 20100, Italy

RECRUITING

Related Publications (29)

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Related Links

• Dalle Grave, R., Sartirana, M., \& Calugi, S. La gestione dei casi complessi nei disturbi dell'alimentazione. Verona: Positive Press, 2019
• Eating Disorders: Recognition and Treatment (NICE Guideline 69).
• Montano, A. \& Flebus, Giovanni Battista. (2006). Presentation of the Beck Depression Inventory - Second edition (BDI-II): Confirmation of bifactorial structure in a sample of the Italian population.
• CG Fairburn - 2010. La terapia cognitivo comportamentale dei disturbi dell'alimentazione. Firenze, Eclipsi; 2010.

MeSH Terms

Conditions

Bulimia Nervosa; Binge-Eating Disorder; Feeding and Eating Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Paolo Brambilla, Professor

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  STUDY CHAIR

Central Study Contacts

Paolo Brambilla, Professor

CONTACT

02 55035982; paolo.brambilla@policlinico.mi.it

Eleonora Tobaldini, Professor

CONTACT

0250319898; Eleonora.Tobaldini@unimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Personnel responsible for HRV analysis and determination of inflammatory biomarker levels will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In order to achieve the objectives of the research project, we will perform a national, monocentric interventional on a medical device study, controlled in 3 parallel and randomized groups with a 1:1:1 allocation ratio.

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 25, 2022
• Study Start: January 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: August 31, 2024
• Last Updated: April 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)