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

NCT02382497 | Unknown

• 1 other identifier: 763_OPBG_2014
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorders; Binge Eating Disorder; Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (16)

• 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

  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

  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

  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.

  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

  6 weeks

Study Arms (4)

AN Active tDCS

EXPERIMENTAL

Treatment "as usual" plus experimental treatment

Device: AN Active tDCS

AN Sham tDCS

SHAM COMPARATOR

Treatment "as usual" plus placebo treatment

Device: AN Sham tDCS

BED Active tDCS

EXPERIMENTAL

Treatment "as usual" plus experimental treatment

Device: BED Active tDCS

BED Sham tDCS

SHAM COMPARATOR

Treatment "as usual" plus placebo treatment

Device: BED Sham tDCS

Interventions

AN Active tDCS DEVICE

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.

Also known as: Brain Stim

AN Active tDCS

AN Sham tDCS DEVICE

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.

Also known as: Brain Stim Sham

AN Sham tDCS

BED Active tDCS DEVICE

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.

Also known as: Brain Stim

BED Active tDCS

BED Sham tDCS DEVICE

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.

Also known as: Brain Stim

BED Sham tDCS

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mariella Enoc: lead

Study Sites (1)

Bambino Gesù Hospital and Research Institute

Rome, 00165, Italy

RECRUITING

Related Publications (2)

• Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.

  PMID: 21320389 BACKGROUND

• Costanzo F, Menghini D, Maritato A, Castiglioni MC, Mereu A, Varuzza C, Zanna V, Vicari S. New Treatment Perspectives in Adolescents With Anorexia Nervosa: The Efficacy of Non-invasive Brain-Directed Treatment. Front Behav Neurosci. 2018 Jul 20;12:133. doi: 10.3389/fnbeh.2018.00133. eCollection 2018.

  PMID: 30083095 RESULT

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Stefano Vicari

  Bambino Gesù Hospital and Research Institute

  STUDY CHAIR

• Floriana Costanzo

  Bambino Gesù Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Floriana Costanzo

CONTACT

0668597091; floriana.costanzo@opbg.net

Valeria Zanna

CONTACT

valeira.zanna@opbg.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Responsible of the Child Neuropsychiatry Unit

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 6, 2015
• Study Start: July 1, 2014
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 19, 2021

Record last verified: 2021-11

Locations

IT (1)