New Treatment Perspectives in Eating Disorders: the Efficacy of

Status Recruiting

Clinical Trial Summary

The present study grounds on the possible role of hemispheric lateralization in Eating disorders (ED): specifically, hyperactivity of the right frontal regions in Anorexia Nervosa (AN), and hypoactivity of the right frontal regions in Binge Eating Disorder (BED) and food craving behaviors. Therefore, the investigators hypothesized that active excitatory tDCS over left prefrontal cortex (PFC) (Anode left/cathode right) may aid in altering/resetting inter-hemispheric balance in AN patients, re-establish control over eating behaviors. On the contrary, active excitatory tDCS over right PFC (Anode right/cathode left) may aid in altering/resetting inter-hemispheric balance in BED patients and people with frequent food cravings, decreasing cravings/appetite binge eating behaviors.

Clinical Trial Description

The study design is randomized stratified, double blind, add-on, placebo-controlled. A group of children and adolescents with AN will be selected and randomly assigned to two different conditions: treatment "as usual" plus experimental treatment (active tDCS); treatment "as usual" plus placebo treatment (sham tDCS). Similarly, a group of children and adolescents with Over-weight/Obesity (OW/OB) and BED will be selected and assigned with randomized stratified sampling to the following conditions: treatment "as usual" plus experimental treatment (active tDCS); treatment "as usual" plus placebo treatment (sham tDCS). In this project, the investigators will work to understand whether a brain-based treatment, with the use of tDCS, can improve the outcome of patients with eating disorders. The investigators will test whether tDCS treatment produces improvements in under-eating and over-eating diseases, such us AN and OW/OB with BED and food craving. Our overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in ED. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02382497
Study type	Interventional
Source	Bambino Gesù Hospital and Research Institute
Contact	Floriana Costanzo
Phone	0668597091
Email	floriana.costanzo@opbg.net
Status	Recruiting
Phase	N/A
Start date	July 2014
Completion date	July 2023

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

New Treatment Perspectives in Eating Disorders: the Efficacy of Non-invasive Brain-directed Treatment

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms