Anorexia Nervosa
Conditions
Keywords
brain stimulation, Body Mass Index
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.
Interventions
DEVICEtranscranial Direct Current Stimulation (tDCS)
transcranial Direct Current Stimulation (tDCS) during 20 sessions
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Dutch 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 |
| 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 65 |
Countries
France
Outcome results
None listed