Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa (EVASTRAM)

Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa : a Randomized Controlled Clinical Trial

Approximately 20% of anorexia nervosa cases do not respond to conventional management strategies: cognitive behavioral therapy, weight gain contract, drug treatments, etc ... - whether they are applied outpatients or during very long hospitalizations. These situations of chronic evolution are characterized by a high rate of mortality. Brain stimulation could be an alternative therapy for these patients. tDCS (transcranial direct current stimulation) is a non-invasive stimulation technique that has demonstrated beneficial effects in other psychiatric conditions such as major depression or schizophrenia.

The objectives of the study will be to evaluate the efficacy of tDCS in anorexia nervosa resistant to conventional treatments on weight gain, eating behavior, psychological and nutritional behavioral scales, cognition, connectivity and brain activity.

Study Overview

• Status: Terminated
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Device: transcranial Direct Current Stimulation (tDCS)

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU Clermont-Ferrand
  • Grenoble, France
    • CHU Grenoble
  • Lyon, France
    • Hospices Civils de Lyon
  • Saint-Etienne, France, 42055
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 anorexia nervosa criteria
• Body Mass Index (BMI) < 17kg/m2
• Conventional treatment failure over the last 12 months
• Refusal or no indication of artificial nutrition

Exclusion Criteria:

• Artificial nutrition
• Other chronic diseases
• drug use (except tobacco)
• pregnancy
• Edinburgh score < 14

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active stimulation; Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with active stimulations	Device: transcranial Direct Current Stimulation (tDCS); transcranial Direct Current Stimulation (tDCS) during 20 sessions
Sham Comparator: Sham stimulation; Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with inactive stimulations	Device: transcranial Direct Current Stimulation (tDCS); transcranial Direct Current Stimulation (tDCS) during 20 sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index (BMI)	Change in body mass index after stimulation sessions. Weight and Height will be combined to report BMI in kg/m^2	weeks 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating Disorder Inventory (EDI)	Change in Eating Disorder Inventory scale after stimulation sessions EDI measures : Drive for thinness (score between 0-4); Bulimia (score between 0-5); Body dissatisfaction (score between 3-10); ineffectiveness (score between 0-6); Perfectionism (score between 0-5); Interpersonal Distrust (score between 0-6); Interoceptive awareness (score between 0-4); Maturity Fears (score between 0-6)	weeks 8
Dutch Eating Behavior Questionnaire (DEBQ)	Change in Dutch Eating Behavior Questionnaire (DEBQ) after stimulation sessions DEBQ measures : Restrained eating (score between 10-30); Emotional eating (score between 17-35); external eating (score between 20-40)	weeks 8
Beck Depression Inventory (BDI)	Change in Beck Depression Inventory after stimulation sessions. BDI measures : No depression : score between 0-9; midl depression or anxiety : score between 10-19; moderate depression or anxiety : score between 20-25; moderate to severe depression or anxiety : score between 26-29; severe depression or anxiety : score between 30-40; very severe depression or anxiety : score between 41-84	weeks 8
State-Trait Anxiety Inventory (STAI)	Change in State-Trait Anxiety Inventory (STAI) after stimulation sessions STAI measures : no anxiety : score between 0-19; very low anxiety : score between 36-45; low anxiety : score between 46-55; moderate anxiety : score between 56-65; high anxiety : score between 56-65; very high anxiety : score greater than 65	weeks 8

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Catherine Massoubre, PhD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2020
• Primary Completion (Actual): May 4, 2022
• Study Completion (Actual): July 13, 2022

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Body Mass Index; brain stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: 1708195; 2018-A02866-49 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No