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

February 16, 2021 updated by: Silvie Ceresnakova

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia, 121 08
        • Department of Psychiatry, Charles University in Prague and General University Hospital in Prague

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anodal tDCS

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
This group gets a real stimulation
Sham Comparator: Sham 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 sham stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the Eating Disorders Examination Questionnaire (EDEq) score
Time Frame: 8 weeks
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
Time Frame: 8 weeks
Comparison of the total scores of the Zung Self-Rating Depression Scale
8 weeks
Change of the pain threshold
Time Frame: 8 weeks
Measurement of the pain threshold with the TSA II Neuro Sensory Analyzer
8 weeks
Change of the weight in kilograms
Time Frame: 8 weeks
Regularly weighting on the scale
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Silvie Ceresnakova

Investigators

  • Study Director: Hana Papezova, Prof.,M.D.,CSc., Department of Psychiatry, Charles University in Prague and General University Hospital in Prague

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2017

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

September 1, 2017

First Submitted That Met QC Criteria

September 2, 2017

First Posted (Actual)

September 6, 2017

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1955/16 S-IV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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