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

Not Applicable

Completed

• Conditions: Anorexia Nervosa
• Interventions: Device: Sham tDCS; Device: Anodal tDCS

• Registration Number: NCT03273205
• Lead Sponsor: Silvie Ceresnakova

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

Study Timeline

• Study Start: 2017-05-22
• Study First Submitted: 2017-09-01
• Study First Submitted QC: 2017-09-02
• Study First Posted: 2017-09-06
• Primary Completion: 2020-04-01
• Status Verified: 2021-02
• Study Completion: 2021-02-01
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tDCS	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)
Anodal tDCS	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)

Primary Outcome Measures

Name	Time	Method
Change of the Eating Disorders Examination Questionnaire (EDEq) score	8 weeks	Comparison of the total scores and subscores of the Eating Disorders Examination Questionnaire (EDEq)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Psychiatry, Charles University in Prague and General University Hospital in Prague; 🇨🇿 Prague, Czechia