Anorexia NervosaNCT05814458
The Efficiency of Transcranial Direct Current Stimulation in the Treatment of Anorexia Nervosa
A study testing tDCS in people with Anorexia Nervosa, run by Medical University of Lublin at 1 site in Poland.
Trial summary
The main goal of the study (a 3-week, randomized, double-blind, and placebo-controlled study) is to determine the effect of Transcranial Direct Current Stimulation (tDCS) on the mental state and advances in nutritional rehabilitation in patients with AN. Read more about this study
- Who is it for?
- Ages 10 to 30 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2022to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 30 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed written Informed Consent Form,
- Patients aged 10-30 years old,
- Meet the DSM-5 criteria for AN,
- Body mass index (BMI) ≤ 17,5 kg/m2,
- A willingness and motivation to follow the study protocol.
Who cannot join
- Not giving Informed, Written Consent
- Diagnosis of neurological diseases, as epilepsy;
- Contraindications to tDCS, ie. pacemakers, metal parts around the head;
- Psychiatric comorbidities (except specific personality disorder) including mental retardation, organic brain dysfunction, or addiction (except nicotine and caffeine);
- Pregnancy or pregnancy planning;
- Changes in psychopharmacotherapy during hospitalization
Trial locations and contacts
1 site in 1 country.
Poland1 site
Ist Department of Psychiatry, Psychotherapy and Early Intervention
Lublin, Lublin Voivodeship, 20-439
About this study
Official title: The Efficiency of Transcranial Direct Current Stimulation in the Treatment of Anorexia Nervosa - a Randomised, Double-blind Clinical Trial
The main goal of the study (a 3-week, randomized, double-blind, and placebo-controlled study) is to determine the effect of Transcranial Direct Current Stimulation (tDCS) on the mental state and advances in nutritional rehabilitation in patients with AN. The primary hypothesis assumes that tDCS will reduce the symptoms of depression, improve cognition functions and it will have a positive effect on the reduction of restriction related to body weight and diet.
Read the detailed description
The aim of the study is to assess the effect of tDCS stimulation on psychological and biological factors in patient suffering for AN with particular attention to the safety of such additional therapy. Transcranial direct current stimulation (tDCS) is a non-invasive and currently considered safe method of neurostimulation. It is based on the use of direct current of very low intensity, up to 2000uA-2mA, and supplying it to the brain through electrodes placed on the scalp. In this way, the polarity of the cell membranes of neurons is induced, and this influences changes in the cortical excitation of the brain.
Results confirming the efficacy of such a therapeutic approach would provide support for the introduction of brain stimulations as a valuable part of treatment in psychiatric wards but also as a part of home-based treatment.
The protocol was developed by a multidisciplinary researcher team of a psychiatrist, psychologist, psychotherapist and nutritionists. Thanks to this, it is possible to evaluate the progress taking place in various fields.
To the best of our knowledge, this will be the first intervention study assessing the efficacy of tDCS in AN taking into account not only psychological tests, but also biochemical markers (including levels of neurotrophins) or the electrical activity of the brain.
- Conditions
- Anorexia Nervosa
- Being tested
- tDCS, Placebo
- Keywords
- Anorexia Nervosa, Brain stimulation, Eating disorders, Left dorsolateral prefrontal cortex, Transcranial direct current stimulation
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Patients will be receiving twice a day tDCS (applied current at 2mA) stimulation, for 3 weeks on working days (30 sessions in total) and each stimulation will last 25 minutes. The anode will be located on the left, while the cathode- on the right dorsolateral prefrontal area of scalp. The commercially available Soterix 1x1 tDCS mini-CT LTE device (model 1601-LTE) will be used for stimulation.
PlaceboDevice
Patients will be receiving twice a day sham stimulation, for 3 weeks on working days (30 sessions in total) and each stimulation will last 25 minutes. The anode will be located on the left, while the cathode- on the right dorsolateral prefrontal area of scalp. The commercially available Soterix 1x1 tDCS mini-CT LTE device (model 1601-LTE) will be used for stimulation.
| Study group | Role | What they receive |
|---|---|---|
| tDCS group | Active comparator | The tDCS group will receive the active brain stimulation. Receives: Device: tDCS |
| Placebo group | Sham comparator | The placebo group will receive the sham brain stimulation. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in severity of eating disorder symptoms 1
The severity of symptoms will be assessed with Eating Attitudes Test (EAT-26)
Measured: The test will be performed four times: Before stimulation, baseline (V1), immediately after stimulation (V2) two weeks after the intervention (V3), and two months after the intervention (V4)
Change in severity of eating disorder symptoms 2
The severity of symptoms will be assessed with Eating Disorder Examination Questionnaire (EDE-Q 6.0).
Measured: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Change in eating habits and opinions about food and nutrition
To evaluate changes in eating habits and opinions about food and nutrition the Questionnaire of Eating Behaviours (QEB) will be used. It is a qualitative questionnaire designed to study eating habits and opinions about food and nutrition. The first part of the questionnaire covers the frequency of consumption of selected products, the frequency of eating meals and their typical composition. In the second part of the questionnaire, there are 26 statements about food and nutrition, which enable the assessment of the level of nutritional knowledge of the respondents.
Measured: The test will be performed two times: Before stimulation, baseline (V1) and two weeks after intervention (V3)
Change in food intake variety
Food Intake Variety will be assessed with The Variety Food Consumption Questionnaire. It is a qualitative food consumption frequency questionnaire. It is a simple tool to collect information on the consumption of (yes / no) 63 assortment groups of products.
Measured: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Change in assessment of stress levels
The severity of stress will be assessed with Perceived Stress Scale (PSS-10). This test consists 10 questions and is used to measure stress based on subjective feelings related to problems and personal events, behavior, coping with stress.
Measured: The test will be performed four times: Before stimulation, baseline (V1), immediately after stimulation (V2) two weeks after the intervention (V3), and two months after the intervention (V4)
Change in severity of depressive symptoms 1
Severity of depressive symptoms will be assessed with Beck's Depression Inventory (BDI)
Measured: The tests will be performed twice: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in severity of depressive symptoms 2
Severity of depressive symptoms will be assessed with Questionnaire for the Diagnosis of Depression in Children and Adolescents (CDI2).
Measured: The tests will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2), and two months after the intervention (V4)
Change in meta-cognition
To assess metacognitive abilities Meta-Cognition Questionnaire (MCQ-A) will be used. Reliable and valid instrument for measuring meta-cognitive beliefs in adolescents (12-18 lat). The MCQ-A assesses the severity of dysfunctional meta-cognitive beliefs in adolescents (12-18) that affect their daily functioning. The first and second subscales measures "positive and negative beliefs about worry," Subscale 3 measures "cognitive confidence," Subscale 4 measures "beliefs about superstition, punishment and responsibility". Finally, subscale 5 measures "cognitive self-consciousness,".
Measured: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2), and two months after the intervention (V4)
Change in attention and perceptiveness
To assess levels of attention Color connection test (CTT-1, CTT-2) and Test of attention and perceptiveness will be used.
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in intensity of intrusive thoughts
To assess intensity of intrusive thoughts CY-BOCS scale will be used
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in intensity of rumination
To assess intensity of rumination the Ruminance-Reflectivity Questionnaire will be used
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in visual memory
To assess visual memory test BENTON will be used. This test is used to test memory, visual perception and graphomotor skills. The examined person draws the presented patterns (10 pieces) from memory or redraws them, depending on the version and methods of the research carried out by the researcher.
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in body image self-esteem
To assess body image self-esteem Appearance Self-Rating Sheet (ASRS) will be used. Assessment of 25 dimensions related to your body - (different parts of your body). The patient receives a visualization of the body figure on the drawing and evaluates its individual elements. The test allows you to assess the importance of appearance for patients, the assessment of satisfaction with one's appearance and the satisfaction index. The SES self-assessment questionnaire will also be used
Measured: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Change in cognitive abilities 1
To assess cognitive abilities Matching Familiar Figures Test (MFF)
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in cognitive abilities 2
To assess cognitive abilities Verbal Fluency Test will be used.
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in self-esteem
The Rosenberg Self-Esteem Scale (SES) will be used. SES is a tool for assessing the level of general self-esteem - a relatively stable disposition understood as a conscious attitude (positive or negative) towards the Self
Measured: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Change in emotion regulation
A shortened 16-item version of a questionnaire designed for the rapid assessment of difficulties in emotion regulation Difficulties in Emotion Regulation Scale DERS-16 wil be performed. The scale measures five domains, such as lack of emotional acceptance, impulsivity, and difficulties with goal-directed behavior, using a 5-point scale.
Measured: The test will be performed three times: at baseline (V1), immediately after stimulation (V2), and 2 months after stimulation (V4).
Change in autistic traits
The Autism Spectrum Quotient (AQ) is a self-administered questionnaire used to measure the degree to which a person shows autistic traits.
Measured: The test will be administered three times: at baseline (V1), immediately after stimulation (V2), and 2 months after stimulation (V4).
Change in mental states
The questionnaire Mentalization Scale (MentS) is used for a rapid assessment of the capacity to reflect on mental states (emotions, intentions, and beliefs).
Measured: The test will be administered three times: at baseline (V1), immediately after stimulation (V2), and 2 months after stimulation (V4).
Change in body-related conversations
Family Talk Questionnaire Fat Talk refers to negative, body-related conversations between girls or young women.
Measured: The test will be peformed three times: at baseline (V1), immediately after stimulation (V2), and 2 months after stimulation (V4).
Change in cognitive functions
A neuropsychological diagnostic tool Rey-Osterrieth Complex Figure used to assess visuospatial abilities, visual memory, and executive functions (planning and organization).
Measured: The test will be performed twice: at baseline (V1), immediately after stimulation (V2)
Change in anxiety level
The STAI (State-Trait Anxiety Inventory) is a psychological tool used to measure anxiety as both a state (a temporary feeling of tension) and a trait (a stable personality disposition). It consists of two subscales (X-1 and X-2, or Y-1 and Y-2), each containing 20 questions, with scores ranging from 20 to 80 points.
Measured: The test will be performed three times: at baseline (V1), immediately after stimulation (V2), and 2 months after stimulation (V4).
Secondary outcomes (26)
Change in electrolyte levels
To evaluate electrolyte levels (mmol/l) in blood serum following tests will be performed:
sodium, phosphorus, magnesium, calcium, potasium
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in morphotic elements 1
To evaluate morphotic elements complete morphology with smear will be performed:
RBC - Red Blood Cell (M/µl)
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in morphotic elements 2
To evaluate morphotic elements complete morphology with smear will be performed:
Hemoglobin (mmol/l) Mean Corpuscular Hemoglobin Concentration (mmol/l)
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in morphotic elements 3
To evaluate morphotic elements complete morphology with smear will be performed:
Hematocrit
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in morphotic elements 4
To evaluate morphotic elements complete morphology with smear will be performed:
Mean Corpuscular Volume (fl)
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in morphotic elements 5
To evaluate morphotic elements complete morphology with smear will be performed:
Mean Corpuscular Hemoglobin (pg)
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in morphotic elements 6
To evaluate morphotic elements complete morphology with smear will be performed:
Ferritin ( ng/ml)
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in morphotic elements 7
To evaluate morphotic elements complete morphology with smear will be performed:
White Blood Cell (K/µl) Lymphocytes (K/µl)
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in morphotic elements 8
To evaluate morphotic elements complete morphology with smear will be performed:
Monocytes (G/l)
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Metabolic changes 1
To evaluate metabolic changes in blood serum Thyroid parameters will be examined: FT3 (pmol/l), FT4 (pmol/l)
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Metabolic changes 2
To evaluate metabolic changes in blood serum the pituitary gland parameter will be examined: TSH (µIU/ml)
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Neurophysiologic changes 1
To evaluate neurophysiologic changes EEG (theta and alpha wave power) test will be performed
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in neurotrophin levels
To evaluate neurotrophin levels in blood serum tests will be performed: BDNF (pg/ml), Neurotrphin 3 and 4 (pg/ml), NGF (pg/ml)
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in food intake regulators:
To evaluate food intake regulators in blood serum tests will be performed: leptin (pg/ml), visfatin (pg/ml)
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Body composition changes 1
To evaluate body composition changes BIA body composition analysis will be performed: Body weight (kg)
Measured: The test will be performed four times: Before stimulation, baseline (V1), immediately after stimulation (V2), two weeks after the intervention (V3), and two months after the intervention (V4)
Body composition changes 2
To evaluate body composition changes BIA body composition analysis will be performed: Intracellular and extracellular water (l/%)
Measured: The test will be performed four times: Before stimulation, baseline (V1), immediately after stimulation (V2), two weeks after the intervention (V3), and two months after the intervention (V4)
Body composition changes 3
To evaluate body composition changes BIA body composition analysis will be performed: Lean body mass (kg/%)
Measured: The test will be performed four times: Before stimulation, baseline (V1), immediately after stimulation (V2), two weeks after the intervention (V3), and two months after the intervention (V4)
Body composition changes 4
To evaluate body composition changes BIA body composition analysis will be performed: Fat mass (kg/%)
Measured: The test will be performed four times: Before stimulation, baseline (V1), immediately after stimulation (V2), two weeks after the intervention (V3), and two months after the intervention (V4)
Changes in HPA axis biomarker
To evaluate HPA axis cortisol (nmol/l) in blood serum will be tested
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Metabolic changes 3
To evaluate metabolic changes in blood serum Total Protein parameter will be examined.
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Metabolic changes 4
To evaluate metabolic changes in blood serum the glucosis level will be performed.
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Cardiac Parameter Changes
To evaluate changes in cardiac parameters in blood serum, NT-proBNP will be measured (pg/mL).
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Metabolic changes 5
To evaluate metabolic changes in blood serum, a lipid profile parameter will be measured: total cholesterol (mg/dL)
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Metabolic changes 6
To evaluate metabolic changes in blood serum, a lipid profile parameter will be measured: LDL cholesterol (mg/dL).
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2).
Metabolic changes 7
To evaluate metabolic changes in blood serum, a lipid profile parameter will be measured: triglycerides (mg/dL).
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2).
Metabolic changes 8
To evaluate metabolic changes in blood serum, a lipid profile parameter will be measured: non-HDL cholesterol (mg/dL).
Measured: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start1 Sep 2022
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanna Karakuła-Juchnowicz, Prof., Study director, 1st Department of Psychiatry, Psychotherapy and Early Intervention, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814458
- Sponsor's protocol ID
- KE-0254/24/01/2022
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2023
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rzad Z, Rog J, Kajka N, Szewczyk P, Krukow P, Karakula-Juchnowicz H. The efficacy of transcranial direct current stimulation in the treatment of anorexia nervosa: a randomized double-blind clinical trial. Front Psychiatry. 2024 May 2;15:1284675. doi: 10.3389/fpsyt.2024.1284675. eCollection 2024.
PubMed 38757134
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Transcranial Direct Current Stimulation in the Treatment of Anorexia Nervosa - a Randomised, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT05814458
- Acronym / sponsor ID
- KE-0254/24/01/2022
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia Nervosa, Brain stimulation, Eating disorders, Left dorsolateral prefrontal cortex, Transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 14 Apr 2023 (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.
The main goal of the study (a 3-week, randomized, double-blind, and placebo-controlled study) is to determine the effect of Transcranial Direct Current Stimulation (tDCS) on the mental state and advances in nutritional rehabilitation in patients with AN. The primary hypothesis assumes that tDCS will reduce the symptoms of depression, improve cognition functions and it will have a positive effect on the reduction of restriction related to body weight and diet.
Detailed description
The aim of the study is to assess the effect of tDCS stimulation on psychological and biological factors in patient suffering for AN with particular attention to the safety of such additional therapy. Transcranial direct current stimulation (tDCS) is a non-invasive and currently considered safe method of neurostimulation. It is based on the use of direct current of very low intensity, up to 2000uA-2mA, and supplying it to the brain through electrodes placed on the scalp. In this way, the polarity of the cell membranes of neurons is induced, and this influences changes in the cortical excitation of the brain.
Results confirming the efficacy of such a therapeutic approach would provide support for the introduction of brain stimulations as a valuable part of treatment in psychiatric wards but also as a part of home-based treatment.
The protocol was developed by a multidisciplinary researcher team of a psychiatrist, psychologist, psychotherapist and nutritionists. Thanks to this, it is possible to evaluate the progress taking place in various fields.
To the best of our knowledge, this will be the first intervention study assessing the efficacy of tDCS in AN taking into account not only psychological tests, but also biochemical markers (including levels of neurotrophins) or the electrical activity of the brain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS group | Active comparator | Device: tDCSThe tDCS group will receive the active brain stimulation. |
| Placebo group | Sham comparator | Device: PlaceboThe placebo group will receive the sham brain stimulation. |
Who may qualify
- Ages
- 10 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Signed written Informed Consent Form,
- Patients aged 10-30 years old,
- Meet the DSM-5 criteria for AN,
- Body mass index (BMI) ≤ 17,5 kg/m2,
- A willingness and motivation to follow the study protocol.
Key exclusion criteria (6 listed)
- Not giving Informed, Written Consent
- Diagnosis of neurological diseases, as epilepsy;
- Contraindications to tDCS, ie. pacemakers, metal parts around the head;
- Psychiatric comorbidities (except specific personality disorder) including mental retardation, organic brain dysfunction, or addiction (except nicotine and caffeine);
- Pregnancy or pregnancy planning;
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 |
|---|---|---|
| tDCSPatients will be receiving twice a day tDCS (applied current at 2mA) stimulation, for 3 weeks on working days (30 sessions in total) and each stimulation will last 25 minutes. The anode will be located on the left, while the cathode- on the right dorsolateral prefrontal area of scalp. The commercially available Soterix 1x1 tDCS mini-CT LTE device (model 1601-LTE) will be used for stimulation. | Device | tDCS group |
| PlaceboPatients will be receiving twice a day sham stimulation, for 3 weeks on working days (30 sessions in total) and each stimulation will last 25 minutes. The anode will be located on the left, while the cathode- on the right dorsolateral prefrontal area of scalp. The commercially available Soterix 1x1 tDCS mini-CT LTE device (model 1601-LTE) will be used for stimulation. | Device | Placebo group |
Primary outcome
Change in severity of eating disorder symptoms 1
Time frame: The test will be performed four times: Before stimulation, baseline (V1), immediately after stimulation (V2) two weeks after the intervention (V3), and two months after the intervention (V4)
The severity of symptoms will be assessed with Eating Attitudes Test (EAT-26)
Change in severity of eating disorder symptoms 2
Time frame: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
The severity of symptoms will be assessed with Eating Disorder Examination Questionnaire (EDE-Q 6.0).
Change in eating habits and opinions about food and nutrition
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and two weeks after intervention (V3)
To evaluate changes in eating habits and opinions about food and nutrition the Questionnaire of Eating Behaviours (QEB) will be used. It is a qualitative questionnaire designed to study eating habits and opinions about food and nutrition. The first part of the questionnaire covers the frequency of consumption of selected products, the frequency of eating meals and their typical composition. In the second part of the questionnaire, there are 26 statements about food and nutrition, which enable the assessment of the level of nutritional knowledge of the respondents.
Change in food intake variety
Time frame: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
Food Intake Variety will be assessed with The Variety Food Consumption Questionnaire. It is a qualitative food consumption frequency questionnaire. It is a simple tool to collect information on the consumption of (yes / no) 63 assortment groups of products.
Change in assessment of stress levels
Time frame: The test will be performed four times: Before stimulation, baseline (V1), immediately after stimulation (V2) two weeks after the intervention (V3), and two months after the intervention (V4)
The severity of stress will be assessed with Perceived Stress Scale (PSS-10). This test consists 10 questions and is used to measure stress based on subjective feelings related to problems and personal events, behavior, coping with stress.
Change in severity of depressive symptoms 1
Time frame: The tests will be performed twice: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Severity of depressive symptoms will be assessed with Beck's Depression Inventory (BDI)
Change in severity of depressive symptoms 2
Time frame: The tests will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2), and two months after the intervention (V4)
Severity of depressive symptoms will be assessed with Questionnaire for the Diagnosis of Depression in Children and Adolescents (CDI2).
Change in meta-cognition
Time frame: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2), and two months after the intervention (V4)
To assess metacognitive abilities Meta-Cognition Questionnaire (MCQ-A) will be used. Reliable and valid instrument for measuring meta-cognitive beliefs in adolescents (12-18 lat). The MCQ-A assesses the severity of dysfunctional meta-cognitive beliefs in adolescents (12-18) that affect their daily functioning. The first and second subscales measures "positive and negative beliefs about worry," Subscale 3 measures "cognitive confidence," Subscale 4 measures "beliefs about superstition, punishment and responsibility". Finally, subscale 5 measures "cognitive self-consciousness,".
Change in attention and perceptiveness
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
To assess levels of attention Color connection test (CTT-1, CTT-2) and Test of attention and perceptiveness will be used.
Change in intensity of intrusive thoughts
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
To assess intensity of intrusive thoughts CY-BOCS scale will be used
Change in intensity of rumination
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
To assess intensity of rumination the Ruminance-Reflectivity Questionnaire will be used
Change in visual memory
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
To assess visual memory test BENTON will be used. This test is used to test memory, visual perception and graphomotor skills. The examined person draws the presented patterns (10 pieces) from memory or redraws them, depending on the version and methods of the research carried out by the researcher.
Change in body image self-esteem
Time frame: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
To assess body image self-esteem Appearance Self-Rating Sheet (ASRS) will be used. Assessment of 25 dimensions related to your body - (different parts of your body). The patient receives a visualization of the body figure on the drawing and evaluates its individual elements. The test allows you to assess the importance of appearance for patients, the assessment of satisfaction with one's appearance and the satisfaction index. The SES self-assessment questionnaire will also be used
Change in cognitive abilities 1
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
To assess cognitive abilities Matching Familiar Figures Test (MFF)
Change in cognitive abilities 2
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
To assess cognitive abilities Verbal Fluency Test will be used.
Change in self-esteem
Time frame: The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)
The Rosenberg Self-Esteem Scale (SES) will be used. SES is a tool for assessing the level of general self-esteem - a relatively stable disposition understood as a conscious attitude (positive or negative) towards the Self
Change in emotion regulation
Time frame: The test will be performed three times: at baseline (V1), immediately after stimulation (V2), and 2 months after stimulation (V4).
A shortened 16-item version of a questionnaire designed for the rapid assessment of difficulties in emotion regulation Difficulties in Emotion Regulation Scale DERS-16 wil be performed. The scale measures five domains, such as lack of emotional acceptance, impulsivity, and difficulties with goal-directed behavior, using a 5-point scale.
Change in autistic traits
Time frame: The test will be administered three times: at baseline (V1), immediately after stimulation (V2), and 2 months after stimulation (V4).
The Autism Spectrum Quotient (AQ) is a self-administered questionnaire used to measure the degree to which a person shows autistic traits.
Change in mental states
Time frame: The test will be administered three times: at baseline (V1), immediately after stimulation (V2), and 2 months after stimulation (V4).
The questionnaire Mentalization Scale (MentS) is used for a rapid assessment of the capacity to reflect on mental states (emotions, intentions, and beliefs).
Change in body-related conversations
Time frame: The test will be peformed three times: at baseline (V1), immediately after stimulation (V2), and 2 months after stimulation (V4).
Family Talk Questionnaire Fat Talk refers to negative, body-related conversations between girls or young women.
Change in cognitive functions
Time frame: The test will be performed twice: at baseline (V1), immediately after stimulation (V2)
A neuropsychological diagnostic tool Rey-Osterrieth Complex Figure used to assess visuospatial abilities, visual memory, and executive functions (planning and organization).
Change in anxiety level
Time frame: The test will be performed three times: at baseline (V1), immediately after stimulation (V2), and 2 months after stimulation (V4).
The STAI (State-Trait Anxiety Inventory) is a psychological tool used to measure anxiety as both a state (a temporary feeling of tension) and a trait (a stable personality disposition). It consists of two subscales (X-1 and X-2, or Y-1 and Y-2), each containing 20 questions, with scores ranging from 20 to 80 points.
26 secondary outcomes
Change in electrolyte levels
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in morphotic elements 1
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in morphotic elements 2
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in morphotic elements 3
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in morphotic elements 4
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in morphotic elements 5
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in morphotic elements 6
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in morphotic elements 7
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in morphotic elements 8
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Metabolic changes 1
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Metabolic changes 2
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Neurophysiologic changes 1
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in neurotrophin levels
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Change in food intake regulators:
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Body composition changes 1
Time frame: The test will be performed four times: Before stimulation, baseline (V1), immediately after stimulation (V2), two weeks after the intervention (V3), and two months after the intervention (V4)
Body composition changes 2
Time frame: The test will be performed four times: Before stimulation, baseline (V1), immediately after stimulation (V2), two weeks after the intervention (V3), and two months after the intervention (V4)
Body composition changes 3
Time frame: The test will be performed four times: Before stimulation, baseline (V1), immediately after stimulation (V2), two weeks after the intervention (V3), and two months after the intervention (V4)
Body composition changes 4
Time frame: The test will be performed four times: Before stimulation, baseline (V1), immediately after stimulation (V2), two weeks after the intervention (V3), and two months after the intervention (V4)
Changes in HPA axis biomarker
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Metabolic changes 3
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Metabolic changes 4
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Cardiac Parameter Changes
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Metabolic changes 5
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Metabolic changes 6
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2).
Metabolic changes 7
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2).
Metabolic changes 8
Time frame: The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Derived from this study: PubMed 38757134Rzad Z, Rog J, Kajka N, Szewczyk P, Krukow P, Karakula-Juchnowicz H. The efficacy of transcranial direct current stimulation in the treatment of anorexia nervosa: a randomized double-blind clinical trial. Front Psychiatry. 2024 May 2;15:1284675. doi: 10.3389/fpsyt.2024.1284675. eCollection 2024.
Related trials for Anorexia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
RecruitingObservational study
Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa
Anorexia Nervosa
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
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.
Hanna Karakuła-Juchnowicz, Prof. study director
1st Department of Psychiatry, Psychotherapy and Early Intervention, Medical University of Lublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Anorexia Nervosa, run by Medical University of Lublin at 1 site in Poland.
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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 2 Feb 2026. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
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 in severity of eating disorder symptoms 1 (time frame: The test will be performed four times: Before stimulation, baseline (V1), immediately after stimulation (V2) two weeks after the intervention (V3), and two months after the intervention (V4)). The study lists 22 primary outcomes in all. 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 NCT05814458, 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 2 Feb 2026.