Anorexia NervosaSANONCT03273205
Transcranial Direct Current Stimulation (tDCS) in the Treatment of Anorexia Nervosa
A study testing Anodal tDCS in people with Anorexia Nervosa, run by Silvie Ceresnakova at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Anodal tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteCzechia
- Study dates
- 22 May 2017to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with the diagnosis of anorexia nervosa
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Psychiatry, Charles University in Prague and General University Hospital in Prague
Prague, 121 08
About this study
Official title: 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.
Read more
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:
- Before the stimulation
- On the day of the last stimulation
- 14 days after the last stimulation
- 28 days after the last stimulation
- Conditions
- Anorexia Nervosa
- Being tested
- Anodal tDCS, Sham tDCS
- Keywords
- Transcranial direct current stimulation (tDCS)
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tDCSDevice
This group gets a real stimulation
Sham tDCSDevice
This group gets a sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Eating Disorders Examination Questionnaire (EDEq) score
Comparison of the total scores and subscores of the Eating Disorders Examination Questionnaire (EDEq)
Measured: 8 weeks
Secondary outcomes (3)
Change of the Zung Self-Rating Depression Scale
Comparison of the total scores of the Zung Self-Rating Depression Scale
Measured: 8 weeks
Change of the pain threshold
Measurement of the pain threshold with the TSA II Neuro Sensory Analyzer
Measured: 8 weeks
Change of the weight in kilograms
Regularly weighting on the scale
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start22 May 2017
- Primary completion1 Apr 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silvie Ceresnakova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Silvie Ceresnakova, Charles University, Czech Republic
- Investigators
- Hana Papezova, Prof.,M.D.,CSc., Study director, Department of Psychiatry, Charles University in Prague and General University Hospital in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273205
- Sponsor's protocol ID
- 1955/16 S-IV
- Acronym
- SANO
- Status last verified
- Feb 2021
- First submitted
- 1 Sep 2017
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Changes in the Body-perception and Perception of the Pain in Patients With Anorexia Nervosa Before and After Using the tDCS
- ClinicalTrials.gov ID
- NCT03273205
- Acronym / sponsor ID
- SANO / 1955/16 S-IV
- Conditions
- Anorexia Nervosa
- Keywords
- Transcranial direct current stimulation (tDCS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Silvie CeresnakovaUniversity, hospital or other
- Study start
- 22 May 2017 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Before the stimulation
- On the day of the last stimulation
- 14 days after the last stimulation
- 28 days after the last stimulation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Experimental | Device: Anodal tDCSThe first group of patients has the real stimulation and the electrodes are placed in this position: Anode: Left DLPFC [F3) Cathode: Right Supraorbital (FP2) |
| Sham tDCS | Sham comparator | Device: Sham tDCSThe 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with the diagnosis of anorexia nervosa
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal tDCSThis group gets a real stimulation | Device | Anodal tDCS |
| Sham tDCSThis group gets a sham stimulation | Device | Sham tDCS |
Primary outcome
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)
3 secondary outcomes
Change of the Zung Self-Rating Depression Scale
Time frame: 8 weeks
Change of the pain threshold
Time frame: 8 weeks
Change of the weight in kilograms
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Derived from this study: PubMed 34690831Baumann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hana Papezova, Prof.,M.D.,CSc. study director
Department of Psychiatry, Charles University in Prague and General University Hospital in Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal tDCS in people with Anorexia Nervosa, run by Silvie Ceresnakova at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the Eating Disorders Examination Questionnaire (EDEq) score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03273205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.