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

NCT ID: NCT03273205

Last Updated: 2021-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-22

Study Completion Date

2021-02-01

Brief Summary

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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

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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

Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

Anodal tDCS

Intervention Type DEVICE

This group gets a real stimulation

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)

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type DEVICE

This group gets a sham stimulation

Interventions

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Anodal tDCS

This group gets a real stimulation

Intervention Type DEVICE

Sham tDCS

This group gets a sham stimulation

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Silvie Ceresnakova

OTHER

Sponsor Role lead

Responsible Party

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Silvie Ceresnakova

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hana Papezova, Prof.,M.D.,CSc.

Role: STUDY_DIRECTOR

Department of Psychiatry, Charles University in Prague and General University Hospital in Prague

Locations

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Department of Psychiatry, Charles University in Prague and General University Hospital in Prague

Prague, , Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type DERIVED
PMID: 34690831 (View on PubMed)

Other Identifiers

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1955/16 S-IV

Identifier Type: -

Identifier Source: org_study_id

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