Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa
- Conditions
- Anorexia Nervosa
- Interventions
- Device: transcranial Direct Current Stimulation (tDCS)
- Registration Number
- NCT03813355
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 17
- 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
- Artificial nutrition
- Other chronic diseases
- drug use (except tobacco)
- pregnancy
- Edinburgh score < 14
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active stimulation transcranial Direct Current Stimulation (tDCS) Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with active stimulations Sham stimulation transcranial Direct Current Stimulation (tDCS) Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with inactive stimulations
- Primary Outcome Measures
Name Time Method Body Mass Index (BMI) weeks 8 Change in body mass index after stimulation sessions. Weight and Height will be combined to report BMI in kg/m\^2
- Secondary Outcome Measures
Name Time Method Eating Disorder Inventory (EDI) weeks 8 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)State-Trait Anxiety Inventory (STAI) weeks 8 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 65Dutch Eating Behavior Questionnaire (DEBQ) weeks 8 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) weeks 8 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
Trial Locations
- Locations (4)
CHU Grenoble
🇫🇷Grenoble, France
CHU Saint-Etienne
🇫🇷Saint-Etienne, France
Hospices Civils de Lyon
🇫🇷Lyon, France
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France