An interventional study of Anodal tDCS and Sham tDCS in Anorexia Nervosa, sponsored by Silvie Ceresnakova. Completed at 1 site in Czechia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-02-17.
Sponsored by Silvie Ceresnakova · Not applicable, Interventional, and Treatment
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.
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:
Exclusion Criteria:
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
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
This group gets a real stimulation
This group gets a sham stimulation
Change of the Eating Disorders Examination Questionnaire (EDEq) score
Comparison of the total scores and subscores of the Eating Disorders Examination Questionnaire (EDEq)
Time frame: 8 weeks
Change of the Zung Self-Rating Depression Scale
Comparison of the total scores of the Zung Self-Rating Depression Scale
Time frame: 8 weeks
Change of the pain threshold
Measurement of the pain threshold with the TSA II Neuro Sensory Analyzer
Time frame: 8 weeks
Change of the weight in kilograms
Regularly weighting on the scale
Time frame: 8 weeks
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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