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

November 12, 2021 updated by: Mariella Enoc

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Rome, Italy, 00165
        • Recruiting
        • Bambino Gesù Hospital and Research Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Under-weight (BMI less than 5th percentile)1 with Clinical diagnosis of AN as described in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
  • Over-weight/Obesity (OW/OB) (BMI above the 85th percentile)1 with diagnosis of BED, or with food craving behaviors
  • Ability to give informed consent under parents' surveillance and guidance

Exclusion Criteria:

  • Having a comorbidity with an important medical condition;
  • Having neurological diseases
  • Having Epilepsy o family history of epilepsy
  • Pregnant or planning to become pregnant;
  • Suicide risk;
  • Receiving counseling or psychological therapies during the study;
  • Receiving a treatment for an eating disorder in the previous three months before the baseline screening visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AN Active tDCS
Treatment "as usual" plus experimental treatment
Device: AN Active tDCS

The tDCS active stimulations will be directed to PFC regions for six weeks delivered for three times a week.

tDCS will be delivered by a battery driven, constant current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands.

The anode will be placed on the left PFC, F3 position according to the 10-20 international EEG system for electrode placement, while the cathode will be placed on the right PFC, F4 position according to the 10-20 international EEG system for electrode placement.

Stimulation intensity will be set at 1 milliampere (mA), the duration of stimulation will be 20 min.

Other Names:
  • Brain Stim
Sham Comparator: AN Sham tDCS
Treatment "as usual" plus placebo treatment
Device: AN Sham tDCS
The same electrode placement will be used as in the stimulation conditions (left anodal/right cathodal), but the current will be applied for 30 s and will be ramped down without the participants awareness, and will be held three times a week for six weeks.
Other Names:
  • Brain Stim Sham
Experimental: BED Active tDCS
Treatment "as usual" plus experimental treatment
Device: BED Active tDCS

The tDCS active stimulations will be directed to PFC regions for six weeks delivered for three times a week.

tDCS will be delivered by a battery driven, constant current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands.

For the OW/OB with diagnosis of BE, or food craving, the anode will be placed on the right PFC, F4 position according to the 10-20 international EEG system for electrode placement, while the cathode will be placed on the left PFC, F3 position according to the 10-20 international EEG system for electrode placement.

Stimulation intensity will be set at 1 milliampere (mA), the duration of stimulation will be 20 min.

Other Names:
  • Brain Stim
Sham Comparator: BED Sham tDCS
Treatment "as usual" plus placebo treatment
Device: BED Sham tDCS
The same electrode placement will be used as in the stimulation conditions (right anodal/left cathodal), but the current will be applied for 30 s and will be ramped down without the participants awareness, and will be held three times a week for six weeks.
Other Names:
  • Brain Stim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary end-point of the study is the mean change in the Overcontrol composite score of Eating Disorder Inventory - Three (EDI-3) questionnaire, using an approach based on the magnitudes of change.
Time Frame: 6 weeks
the mean change in the Overcontrol composite score of the EDI-3 questionnaire gives a measure of the basic characteristics of the eating disorders and is a prognostic measure of outcome of eating disorders. Indeed, patterns of treatment response revealed significantly changes in terms of reduced eating disorder symptoms and fewer psychological problems.
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients in the two arms with improvement in the total scores of other psychopathological measures as the Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS) questionnaire
Time Frame: 6 weeks
6 weeks
The proportion of patients in the two arms with improvement in the total scores of other psychopathological measures as the BINGE EATING SCALE (BES) questionnaire
Time Frame: 6 weeks
6 weeks
The proportion of patients in the two arms with improvement in the neuropsychological measure of executive control and reward sensitivity by the 'Bechara Iowa Gambling' Task
Time Frame: 6 weeks
6 weeks
The proportion of patients in the two arms with improvement in the neuropsychological measure of the ability to stop by THE STOP-SIGNAL REACTION-TIME (SSRT) task.
Time Frame: 6 weeks
6 weeks
The proportion of patients in the two arms with improvement in the neuropsychological measure of visual attention and task switching by the TRAIL MAKING TEST
Time Frame: 6 weeks
6 weeks
The proportion of patients in the two arms with normalization of different physiological measures specifically the BMI index
Time Frame: 12 months follow up
12 months follow up
The proportion of patients in the two arms with normalization of different physiological measures specifically the values of bloody pressure
Time Frame: 12 months follow up
12 months follow up
The proportion of patients in the two arms with normalization of different physiological measures specifically the values of cardiac frequency
Time Frame: 12 months follow up
12 months follow up
The proportion of patients in the two arms with normalization of different physiological measures specifically the values of body composition
Time Frame: 12 months follow up
12 months follow up
In the AN group, significant changes in intra-cortical inhibitory/excitatory motor circuits using paired pulse TMS, measured as SICI/ICF: the ratio between MEPs amplitude (mV) conditioning stimulus and MEPs amplitude test stimulus alone for each ISI.
Time Frame: 6 weeks
6 weeks
In the AN group, significant changes in sensory-motor integration using paired pulse TMS, measured as SICI/ICF: the ratio between MEPs amplitude (mV) conditioning stimulus (electrical stimulation) and MEP amplitude test stimulus alone for each ISI.
Time Frame: 6 weeks
6 weeks
In the AN group, significant changes in cortical oscillatory patterns (synchronization and desynchronization) in theta, alpha and beta frequencies (Hz) over motor and premotor cortex, using TMS-EEG co-registration.
Time Frame: 6 weeks
6 weeks
In the AN group, normalization of endogenous stress response, measured with CAR.
Time Frame: 6 months follow up
6 months follow up
In the AN group, significant changes in cortical connectivity, through the analysis of the waveform, latency and cortical distribution of TMS-evoked potentials (TEPs) in micronV, using TMS-EEG co-registration.
Time Frame: 6 weeks
6 weeks
In the AN group, significant changes in cortical reactivity in terms of TMS-evoked potentials (TEPs) amplitude for time domain (micronV) and frequency bands for spatial domain (Hz), using TMS-EEG co-registration.
Time Frame: 6 weeks
6 weeks
In the AN group, significant changes in Cortical Plasticity evoked by repetitive TMS in terms of different MEP amplitude (mV) recorded at different time-points after repetitive TMS perturbations.
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mariella Enoc

Investigators

  • Principal Investigator: Floriana Costanzo, Bambino Gesù Hospital and Research Institute
  • Study Chair: Stefano Vicari, Bambino Gesù Hospital and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Actual)

November 19, 2021

Last Update Submitted That Met QC Criteria

November 12, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 763_OPBG_2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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