Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa (EVASTRAM)

Centre Hospitalier Universitaire de Saint Etienne

Status: Terminated

Conditions: Anorexia Nervosa

Treatments: Device: transcranial Direct Current Stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03813355

2018-A02866-49 (Other Identifier)

1708195

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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17 participants in 2 patient groups

Active stimulation

Experimental group

Description:

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

Treatment:

Device: transcranial Direct Current Stimulation (tDCS)

Sham stimulation

Sham Comparator group

Description:

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

Treatment:

Device: transcranial Direct Current Stimulation (tDCS)