NCT03273205

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

2.9 years

First QC Date

September 1, 2017

Last Update Submit

February 16, 2021

Conditions

Anorexia Nervosa

Keywords

Transcranial direct current stimulation (tDCS)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change of the Zung Self-Rating Depression Scale

    8 weeks

  • Change of the pain threshold

    8 weeks

  • Change of the weight in kilograms

    8 weeks

Study Arms (2)

Anodal tDCS

EXPERIMENTAL

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

Sham tDCS

SHAM COMPARATOR

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

Interventions

Anodal tDCSDEVICE

This group gets a real stimulation

Anodal tDCS
Sham tDCSDEVICE

This group gets a sham stimulation

Sham tDCS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with the diagnosis of anorexia nervosa

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Prague, 121 08, Czechia

Location

Related Publications (1)

  • 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.

    PMID: 34690831DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Hana Papezova, Prof.,M.D.,CSc.

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 1, 2017

First Posted

September 6, 2017

Study Start

May 22, 2017

Primary Completion

April 1, 2020

Study Completion

February 1, 2021

Last Updated

February 17, 2021

Record last verified: 2021-02

Locations

CZ(1)