Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa

Study Overview
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Brief Summary
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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.

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

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Device: transcranial Direct Current Stimulation (tDCS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain stimulation, Body Mass Index