Clinical trial NCT03273205: Transcranial Direct Current Stimulation (tDCS) in the Treatment of Anorexia Nervosa
Official title: The Changes in the Body-perception and Perception of the Pain in Patients With Anorexia Nervosa Before and After Using the tDCS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Transcranial direct current stimulation (tDCS)
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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:

1. Before the stimulation
2. On the day of the last stimulation
3. 14 days after the last stimulation
4. 28 days after the last stimulation

Eligibility criteria: 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.

Primary outcomes:
measure: Change of the Eating Disorders Examination Questionnaire (EDEq) score
timeFrame: 8 weeks
Secondary outcomes:
measure: Change of the Zung Self-Rating Depression Scale
timeFrame: 8 weeks
measure: Change of the pain threshold
timeFrame: 8 weeks
measure: Change of the weight in kilograms
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Department of Psychiatry, Charles University in Prague and General University Hospital in Prague
Study officials:
affiliation: Department of Psychiatry, Charles University in Prague and General University Hospital in Prague
name: Hana Papezova, Prof.,M.D.,CSc.
role: STUDY_DIRECTOR
References:
citation: Baumann S, Mares T, Albrecht J, Anders M, Vochoskova K, Hill M, Bulant J, Yamamotova A, Stastny O, Novak T, Holanova P, Lambertova A, Papezova H. Effects of Transcranial Direct Current Stimulation Treatment for Anorexia Nervosa. Front Psychiatry. 2021 Oct 6;12:717255. doi: 10.3389/fpsyt.2021.717255. eCollection 2021.