Transcranial Direct Current Stimulation (tDCS) in the Treatment of Anorexia Nervosa

Study Overview
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Brief Summary
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Anorexia Nervosa (AN) is a serious and often chronical eating disorder characterized by an extreme effort for weight loss and intense fear of becoming fat despite the obvious thinness. The treatment is very difficult and not always effective. That´s the reason why we are looking for new ways of the therapeutic approach. Transcranial direct current stimulation (tDCS) is a neuromodulation technique, which modulates the neuronal excitability. According to previous research it has a potential to help people with Anorexia Nervosa. The device for the tDCS has two electrodes, an anode (the excitatory one) and a cathode (the inhibitory one). We put them on the skull into the different positions, in dependence on the fact, if we want to excite or on to inhibit the parts of the brain under the electrodes. There are several hypothesis how could the tDCS help in patients with AN. One of them speaks about the hyperactivity of the right hemisphere in Anorexia Nervosa. Therefore could the anodal (excitatory) tDCS over the left hemisphere and the cathodal (inhibitory one) help in resetting the inter-hemispheric balance.

Detailed Description
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Stimulation of 2 milliampere is applied for 30 minutes in every real session. Together there are 10 sessions, the application is every workday within 2 weeks. All measurements and questionnaires are made 4 times: Before the stimulation On the day of the last stimulation 14 days after the last stimulation 28 days after the last stimulation

Official Title
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The Changes in the Body-perception and Perception of the Pain in Patients With Anorexia Nervosa Before and After Using the tDCS

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Device: Anodal tDCS
* Device: Sham tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with the diagnosis of anorexia nervosa Exclusion Criteria: patients: with the diagnosis of epilepsy, after a serious injury of head, with chronic headache, with some metal or electronic implants in their heads and patients who are pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anodal tDCS<br>The first group of patients has the real stimulation and the electrodes are placed in this position: Anode: Left DLPFC [F3) Cathode: Right Supraorbital (FP2) | Device: Anodal tDCS<br>* This group gets a real stimulation<br>|
| Sham Comparator: Sham tDCS<br>The second group has the sham stimulation, but the electrodes are placed in the same position as in the first group: Anode: Left DLPFC [F3) Cathode: Right Supraorbital (FP2) | Device: Sham tDCS<br>* This group gets a sham stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the Eating Disorders Examination Questionnaire (EDEq) score | Comparison of the total scores and subscores of the Eating Disorders Examination Questionnaire (EDEq) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the Zung Self-Rating Depression Scale | Comparison of the total scores of the Zung Self-Rating Depression Scale | 8 weeks | 
| Change of the pain threshold | Measurement of the pain threshold with the TSA II Neuro Sensory Analyzer | 8 weeks | 
| Change of the weight in kilograms | Regularly weighting on the scale | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial direct current stimulation (tDCS)