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CompletedNCT03273205SANOUpdated Feb 17, 2021

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

An interventional study of Anodal tDCS and Sham tDCS in Anorexia Nervosa, sponsored by Silvie Ceresnakova. Completed at 1 site in Czechia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-02-17.

Sponsored by Silvie Ceresnakova · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Anorexia Nervosa

Keywords

  • Transcranial direct current stimulation (tDCS)
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with the diagnosis of anorexia nervosa

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
43 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceAnodal tDCS

    This group gets a real stimulation

  • DeviceSham tDCS

    This group gets a sham stimulation

05

What researchers measure

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)

    Time frame: 8 weeks

Secondary outcomes

  1. Change of the Zung Self-Rating Depression Scale

    Comparison of the total scores of the Zung Self-Rating Depression Scale

    Time frame: 8 weeks

  2. Change of the pain threshold

    Measurement of the pain threshold with the TSA II Neuro Sensory Analyzer

    Time frame: 8 weeks

  3. Change of the weight in kilograms

    Regularly weighting on the scale

    Time frame: 8 weeks

06

Study locations

1 site
  • Department of Psychiatry, Charles University in Prague and General University Hospital in Prague
    Prague, 121 08, Czechia
07

References and documents

Publications

  • 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. PubMed 34690831 ↗
08

Registry details

Key details

Study ID
NCT03273205
Lead sponsor
Silvie Ceresnakova
Responsible party
Silvie Ceresnakova (Principal Investigator, Charles University, Czech Republic) — Sponsor-investigator
First posted
Sep 6, 2017
Start date
May 22, 2017
Primary completion
Apr 1, 2020
Completion
Feb 1, 2021
Last update
Feb 17, 2021

Study contacts

Hana Papezova, Prof.,M.D.,CSc.
study director · Department of Psychiatry, Charles University in Prague and General University Hospital in Prague

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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