Transcranial Direct Current Stimulation (tDCS) in the Treatment of Anorexia Nervosa (SANO)
Primary Purpose
Anorexia Nervosa
Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Anodal tDCS
Sham tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa focused on measuring Transcranial direct current stimulation (tDCS)
Eligibility Criteria
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.
Sites / Locations
- Department of Psychiatry, Charles University in Prague and General University Hospital in Prague
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Anodal tDCS
Sham tDCS
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
Change of the Eating Disorders Examination Questionnaire (EDEq) score
Comparison of the total scores and subscores of the Eating Disorders Examination Questionnaire (EDEq)
Secondary Outcome Measures
Change of the Zung Self-Rating Depression Scale
Comparison of the total scores of the Zung Self-Rating Depression Scale
Change of the pain threshold
Measurement of the pain threshold with the TSA II Neuro Sensory Analyzer
Change of the weight in kilograms
Regularly weighting on the scale
Full Information
NCT ID
NCT03273205
First Posted
September 1, 2017
Last Updated
February 16, 2021
Sponsor
Silvie Ceresnakova
1. Study Identification
Unique Protocol Identification Number
NCT03273205
Brief Title
Transcranial Direct Current Stimulation (tDCS) in the Treatment of Anorexia Nervosa
Acronym
SANO
Official Title
The Changes in the Body-perception and Perception of the Pain in Patients With Anorexia Nervosa Before and After Using the tDCS
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
February 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Silvie Ceresnakova
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
Before the stimulation
On the day of the last stimulation
14 days after the last stimulation
28 days after the last stimulation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Transcranial direct current stimulation (tDCS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anodal tDCS
Arm Type
Experimental
Arm Description
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)
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Anodal tDCS
Intervention Description
This group gets a real stimulation
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
This group gets a sham stimulation
Primary Outcome Measure Information:
Title
Change of the Eating Disorders Examination Questionnaire (EDEq) score
Description
Comparison of the total scores and subscores of the Eating Disorders Examination Questionnaire (EDEq)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change of the Zung Self-Rating Depression Scale
Description
Comparison of the total scores of the Zung Self-Rating Depression Scale
Time Frame
8 weeks
Title
Change of the pain threshold
Description
Measurement of the pain threshold with the TSA II Neuro Sensory Analyzer
Time Frame
8 weeks
Title
Change of the weight in kilograms
Description
Regularly weighting on the scale
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hana Papezova, Prof.,M.D.,CSc.
Organizational Affiliation
Department of Psychiatry, Charles University in Prague and General University Hospital in Prague
Official's Role
Study Director
Facility Information:
Facility Name
Department of Psychiatry, Charles University in Prague and General University Hospital in Prague
City
Prague
ZIP/Postal Code
121 08
Country
Czechia
12. IPD Sharing Statement
Citations:
PubMed Identifier
34690831
Citation
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.
Results Reference
derived
Learn more about this trial
Transcranial Direct Current Stimulation (tDCS) in the Treatment of Anorexia Nervosa
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