Transcranial Direct Current Stimulation (tDCS) and Anorexia Nervosa

Study Overview
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Brief Summary
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Anorexia nervosa is an eating disorder characterized by intense fear of becoming fat despite the obvious thinness and extreme behaviors for weight loss. The result is a massive weight loss and / or pathological thinness. The care of anorexia is difficult and few treatments have proved to be effective in adults. Transcranial direct current stimulation (tDCS) is a neuromodulation technique that uses an electrical current of low intensity. It allows to modulate the corticospinal excitability: two electrodes, an anode (excitatory) and a cathode (inhibitory), are positioned on the skull according to the region which is desired to influence the operation. Although tDCS was shown to no noticeable side effects, it is first necessary to assess the feasibility and safety of this technique in these physically frail patients. A recent pilot study suggests the acceptability, safety and efficacy of tDCS program in patients with anorexia nervosa. Given these preliminary data and the extreme seriousness and vulnerability of patients with resistant anorexia, the investigators want to assess the risk / benefit ratio for the use of this technique in patients suffering from resistant anorexia nervosa. The current data are too preliminary to consider a randomized controlled trial, the investigators hope, initially, replicate the data from this pilot study in a second sample with a more rigorous and comprehensive assessment methodology .

Detailed Description
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During stimulation, the anode will be placed over the left dorsolateral prefrontal cortex and the cathode on the right dorsolateral prefrontal cortex. Stimulation of 2 milli-Ampere is applied for 25 minutes each session. 20 sessions will be conducted twice a day respecting a period of four hours between sessions. The tDCS sessions will start maximum 15 days after the inclusion visit. Two intermediate control visits will be conducted. One after the first week of tDCS, the other immediately after the last session of tDCS. The main assessment visit will be carried out one month (+/- 5 days) after the last session of tDCS. Finally a reminder visit will be performed 6 months (+/- 3 weeks) after the last session of tDCS to assess the stability over time of the potential effects observed.

Official Title
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Measuring the Effect of a Program of 20 Sessions of Transcranial Direct Current Stimulation With 2 Milli-ampere Targeting the Dorsolateral Prefrontal Cortex on the Symptoms of Anorexia Nervosa: An Open Label Uncontrolled Pilots Study

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Device: Transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Present a current anorexia nervosa (according to Diagnostic and Statistical Manual of Mental Disorders (DSM V)) ,severe, for at least 3 years Attest to the failure of at least one outpatient treatment conducted by a specialized team (Level 2/3) for the management of patients with eating disorders according to the criteria of French Association for the Development of Specialized Approaches of eating disorders and General Direction of the care Have an effective mean of contraception throughout the study Being able to understand the nature, purpose and methodology of the study Being affiliated to a social security scheme or being the beneficiary of such a scheme. Having signed the informed consent Exclusion Criteria: Refusal to participate Present a body mass index lower than 13.5 Present a history of seizures or epilepsy Presenting a head injury and / or brain pathology Presenting an unstabilized serious physical illness Present pregnancy (attested by a blood test Beta-HCG) or breastfeeding Present physical disease that may affect cognitive abilities and brain structures (eg HIV infection, multiple sclerosis, lupus, Parkinson's disease, epilepsy, dementia ...) Deprived of liberty subject (judicial or administrative decision) People protected by law

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial direct current stimulation<br>10 patients will be stimulated twice a day for two weeks or 20 sessions. 2 milli ampere stimulation will be applied for 25 min respecting a period of four hours between sessions. | Device: Transcranial direct current stimulation<br>* Anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the Eating Disorders Examination Questionnaire (EDEq) score | Comparison between the total score of the Eating Disorders Examination Questionnaire (EDEq) 28 days before tDCS program and 28 days after the end of a program of 20 sessions of tDCS with 2 milliampere targeting dorsolateral prefrontal cortex | At the baseline and 1 month after the last session of tDCS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events assessed by tDCS adverse effect questionnaire | Evaluate the safety of this program: side effects, early termination of the patient, acceptability | At the end of the first and second week of stimulation | 
| Evolution of depressive symptoms assessed by patients with Beck Depression Inventory (BDI) questionnaire | Evaluate the evolution of mood as an associated symptoms of anorexia nervosa | At the baseline, the end of the first and second week of stimulation, 1 month and 6 months after the last session of tDCS | 
| Evolution of depressive symptoms assessed by the psychiatrist by Montgomery Asberg Depression Rating Scale (MADRS) | Evaluate the evolution of mood as an associated symptoms of anorexia nervosa | At the baseline, 1 month and 6 months after the last session of tDCS | 
| Evolution of mania symptoms assessed by the physician with Young Mania Rating Scale (YMRS) | Evaluate the evolution of mood as an associated symptoms of anorexia nervosa | At the baseline, the end of the first and second week of stimulation, 1 month and 6 months after the last session of tDCS | 
| Evolution of the Exercise Dependence Scale (EDS-R) score | Evaluate the evolution of physical activity as an associated symptoms of anorexia nervosa | At the baseline, 1 month and 6 months after the last session of tDCS | 
| Evolution of the Global Physical Activity Questionnaire (GPAQ) score | Evaluate the evolution of physical activity as an associated symptoms of anorexia nervosa | At the baseline, 1 month and 6 months after the last session of tDCS | 
| Evolution of the Maudsley Obsessive Compulsive Inventory (MOCI) score | Evaluate the evolution of obsessiveness as an associated symptoms of anorexia nervosa sensitivity | At the baseline, 1 month and 6 months after the last session of tDCS | 
| Evolution of the sensitivity to punishment and sensitivity reward questionnaire | Evaluate the evolution of reward sensitivity as an associated symptoms of anorexia nervosa sensitivity | At the baseline, 1 month and 6 months after the last session of tDCS | 
| Evolution of the neuropsychological performance measured with the National Adult Reading Test (NART) | Evaluate the evolution of neuropsychological performance as an associated symptoms of anorexia nervosa sensitivity | At the baseline and 1 month after the last session of tDCS | 
| Evolution of the neuropsychological performance measured with the Iowa Gambling Task (IGT) | Evaluate the evolution of neuropsychological performance as an associated symptoms of anorexia nervosa sensitivity | At the baseline and 1 month after the last session of tDCS | 
| Evolution of the neuropsychological performance measured with the Brixton test | Evaluate the evolution of neuropsychological performance as an associated symptoms of anorexia nervosa sensitivity | At the baseline and 1 month after the last session of tDCS | 
| Evolution of the neuropsychological performance measured with the Rey-Osterrieth Complex Figure | Evaluate the evolution of neuropsychological performance as an associated symptoms of anorexia nervosa sensitivity | At the baseline and 1 month after the last session of tDCS | 
| Evolution of the neuropsychological performance measured with the D2 test | Evaluate the evolution of neuropsychological performance as an associated symptoms of anorexia nervosa sensitivity | At the baseline and 1 month after the last session of tDCS | 
| Evolution of the patient's level of function measured with the Work and Social Adjustment Scale (WSAS) | Evaluate the evolution of the patient's level of function as an associated symptoms of anorexia nervosa sensitivity | 6 months | 
| Evolution of the patient's level of function measured with the Global Assessment of Functioning (GAF) | Evaluate the evolution of the patient's level of function as an associated symptoms of anorexia nervosa sensitivity | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sever anorexia nervosa