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Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa (EVASTRAM)

Primary Purpose

Anorexia Nervosa

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transcranial Direct Current Stimulation (tDCS)
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring brain stimulation, Body Mass Index

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active stimulation

Sham stimulation

Arm Description

Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with active stimulations

Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with inactive stimulations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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)
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
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

Full Information

First Posted
December 20, 2018
Last Updated
April 5, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT03813355
Brief Title
Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa
Acronym
EVASTRAM
Official Title
Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa : a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
lack of inclusion to meet the evaluation criteria
Study Start Date
October 21, 2020 (Actual)
Primary Completion Date
May 4, 2022 (Actual)
Study Completion Date
July 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
brain stimulation, Body Mass Index

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active stimulation
Arm Type
Experimental
Arm Description
Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with active stimulations
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with inactive stimulations
Intervention Type
Device
Intervention Name(s)
transcranial Direct Current Stimulation (tDCS)
Intervention Description
transcranial Direct Current Stimulation (tDCS) during 20 sessions
Primary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
Change in body mass index after stimulation sessions. Weight and Height will be combined to report BMI in kg/m^2
Time Frame
weeks 8
Secondary Outcome Measure Information:
Title
Eating Disorder Inventory (EDI)
Description
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)
Time Frame
weeks 8
Title
Dutch Eating Behavior Questionnaire (DEBQ)
Description
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)
Time Frame
weeks 8
Title
Beck Depression Inventory (BDI)
Description
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
Time Frame
weeks 8
Title
State-Trait Anxiety Inventory (STAI)
Description
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
Time Frame
weeks 8

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Massoubre, PhD
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Facility Name
CHU Grenoble
City
Grenoble
Country
France
Facility Name
Hospices Civils de Lyon
City
Lyon
Country
France
Facility Name
CHU Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa

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