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

Anorexia Nervosa Clinical Trial

— SANO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03273205
• Other study ID #: 1955/16 S-IV
• Status: Completed
• Phase: N/A
• Start date: May 22, 2017
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2021
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 1, 2021
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Device:
• Anodal tDCS
This group gets a real stimulation
• Sham tDCS
This group gets a sham stimulation

Locations

Country	Name	City	State
Czechia	Department of Psychiatry, Charles University in Prague and General University Hospital in Prague	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Silvie Ceresnakova

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of the Zung Self-Rating Depression Scale	Comparison of the total scores of the Zung Self-Rating Depression Scale	8 weeks
Secondary	Change of the pain threshold	Measurement of the pain threshold with the TSA II Neuro Sensory Analyzer	8 weeks
Secondary	Change of the weight in kilograms	Regularly weighting on the scale	8 weeks