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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02866-49 | Other Identifier | ANSM |
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lack of inclusion to meet the evaluation criteria
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active stimulation | Experimental | Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with active stimulations |
|
| Sham stimulation | Sham Comparator | Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with inactive stimulations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial Direct Current Stimulation (tDCS) | Device | transcranial Direct Current Stimulation (tDCS) during 20 sessions |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Eating Disorder Inventory (EDI) | Change in Eating Disorder Inventory scale after stimulation sessions EDI measures :
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Massoubre, PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | France | ||||
| CHU Grenoble |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| weeks 8 |
| Dutch Eating Behavior Questionnaire (DEBQ) | Change in Dutch Eating Behavior Questionnaire (DEBQ) after stimulation sessions DEBQ measures :
| weeks 8 |
| Beck Depression Inventory (BDI) | Change in Beck Depression Inventory after stimulation sessions. BDI measures :
| weeks 8 |
| State-Trait Anxiety Inventory (STAI) | Change in State-Trait Anxiety Inventory (STAI) after stimulation sessions STAI measures :
| weeks 8 |
| Grenoble |
| France |
| Hospices Civils de Lyon | Lyon | France |
| CHU Saint-Etienne | Saint-Etienne | 42055 | France |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |