ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02382497
Recruitment Status : Unknown
Verified March 2015 by Bambino Gesù Children's Hospital, Bambino Gesù Hospital and Research Institute.
Recruitment status was:  Recruiting
First Posted : March 6, 2015
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Bambino Gesù Children's Hospital, Bambino Gesù Hospital and Research Institute

Brief 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.


Condition or disease Intervention/treatment Phase
Eating Disorders Binge Eating Disorder Anorexia Nervosa Device: AN Active tDCS Device: AN Sham tDCS Device: BED Active tDCS Device: BED Sham tDCS Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: New Treatment Perspectives in Eating Disorders: the Efficacy of Non-invasive Brain-directed Treatment
Study Start Date : July 2014
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

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 Name: 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 Name: 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 Name: 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 Name: Brain Stim




Primary Outcome Measures :
  1. The proportion of patients in the two arms with change in at least 1 point of the total score of the EATING DISORDER INVENTORY-THREE (EDI-3) questionnaire [ Time Frame: 6 weeks ]
    the improving in the total 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, fewer psychological problems and a more positive self-image


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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. The proportion of patients in the two arms with normalization of different physiological measures specifically the BMI index [ Time Frame: 12 month follow up ]
  7. The proportion of patients in the two arms with normalization of different physiological measures specifically the values of bloody pressure [ Time Frame: 12 month follow up ]
  8. The proportion of patients in the two arms with normalization of different physiological measures specifically the values of cardiac frequency [ Time Frame: 12 month follow up ]
  9. The proportion of patients in the two arms with normalization of different physiological measures specifically the values of body composition [ Time Frame: 12 month follow up ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382497


Contacts
Contact: Deny Menghini 06.6859. 2875 deny.menghini@opbg.net
Contact: Floriana Costanzo floriana.costanzo@opbg.net

Locations
Italy
Bambino Gesù Hospital and Research Institute Recruiting
Rome, Italy, 00165
Contact: Chiara Mennini    06-68592572    chiara.mennini@opbg.net   
Contact: Rita Alparone    06-68593580    rita.alparone@opbg.net   
Sponsors and Collaborators
Bambino Gesù Children's Hospital
Investigators
Principal Investigator: Stefano Vicari Bambino Gesù Hospital and Research Institute

Publications of Results:

Responsible Party: Bambino Gesù Children's Hospital, Responsible of the Child Neuropsychiatry Unit, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT02382497     History of Changes
Other Study ID Numbers: 763_OPBG_2014
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Binge-Eating Disorder
Mental Disorders
Anorexia
Anorexia Nervosa
Bulimia
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Hyperphagia