Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT05814458
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2023-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficiency of Transcranial Direct Current Stimulation in the Treatment of Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2023-01-31', 'studyFirstSubmitQcDate': '2023-04-12', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in severity of eating disorder symptoms 1', 'timeFrame': 'The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)', 'description': 'The severity of symptoms will be assessed with Eating Attitudes Test (EAT-26)'}, {'measure': 'Change in severity of eating disorder symptoms 2', 'timeFrame': 'The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)', 'description': 'The severity of symptoms will be assessed with Eating Disorder Examination Questionnaire (EDE-Q 6.0).'}, {'measure': 'Change in eating habits and opinions about food and nutrition', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and two weeks after intervention (V3)', 'description': '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.'}, {'measure': 'Change in food intake variety', 'timeFrame': 'The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)', 'description': '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.'}, {'measure': 'Change in assessment of stress levels', 'timeFrame': 'The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)', 'description': '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.'}, {'measure': 'Change in severity of depressive symptoms 1', 'timeFrame': 'The tests will be performed twice: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': "Severity of depressive symptoms will be assessed with Beck's Depression Inventory (BDI)"}, {'measure': 'Change in severity of depressive symptoms 2', 'timeFrame': 'The tests will be performed twice: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'Severity of depressive symptoms will be assessed with Questionnaire for the Diagnosis of Depression in Children and Adolescents (CDI2).'}, {'measure': 'Change in meta-cognition', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': '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,".'}, {'measure': 'Change in attention and perceptiveness', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'To assess levels of attention Color connection test (CTT-1, CTT-2) and Test of attention and perceptiveness will be used.'}, {'measure': 'Change in intensity of intrusive thoughts', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'To assess intensity of intrusive thoughts CY-BOCS scale will be used'}, {'measure': 'Change in intensity of rumination', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'To assess intensity of rumination the Ruminance-Reflectivity Questionnaire will be used'}, {'measure': 'Change in visual memory', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': '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.'}, {'measure': 'Change in body image self-esteem', 'timeFrame': 'The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)', 'description': "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"}, {'measure': 'Change in cognitive abilities 1', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'To assess cognitive abilities Matching Familiar Figures Test (MFF)'}, {'measure': 'Change in cognitive abilities 2', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'To assess cognitive abilities Verbal Fluency Test will be used.'}, {'measure': 'Change in self-esteem', 'timeFrame': 'The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Change in electrolyte levels', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'To evaluate electrolyte levels (mmol/l) in blood serum following tests will be performed:\n\nsodium, phosphorus, magnesium, calcium'}, {'measure': 'Change in morphotic elements 1', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'To evaluate morphotic elements complete morphology with smear will be performed:\n\nRBC - Red Blood Cell (M/µl)'}, {'measure': 'Change in morphotic elements 2', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'To evaluate morphotic elements complete morphology with smear will be performed:\n\nHemoglobin (mmol/l) Mean Corpuscular Hemoglobin Concentration (mmol/l)'}, {'measure': 'Change in morphotic elements 3', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'To evaluate morphotic elements complete morphology with smear will be performed:\n\nHematocrit'}, {'measure': 'Change in morphotic elements 4', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'To evaluate morphotic elements complete morphology with smear will be performed:\n\nMean Corpuscular Volume (fl)'}, {'measure': 'Change in morphotic elements 5', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'To evaluate morphotic elements complete morphology with smear will be performed:\n\nMean Corpuscular Hemoglobin (pg)'}, {'measure': 'Change in morphotic elements 6', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'To evaluate morphotic elements complete morphology with smear will be performed:\n\nFerritin ( ng/ml)'}, {'measure': 'Change in morphotic elements 7', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'To evaluate morphotic elements complete morphology with smear will be performed:\n\nWhite Blood Cell (K/µl) Lymphocytes (K/µl)'}, {'measure': 'Change in morphotic elements 8', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'To evaluate morphotic elements complete morphology with smear will be performed:\n\nMonocytes (G/l)'}, {'measure': 'Metabolic changes 1', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'To evaluate metabolic changes in blood serum Thyroid parameters will be examined: FT3 (pmol/l), FT4 (pmol/l)'}, {'measure': 'Metabolic changes 2', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'To evaluate metabolic changes in blood serum the pituitary gland parameter will be examined: TSH (µIU/ml)'}, {'measure': 'Neurophysiologic changes 1', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'To evaluate neurophysiologic changes EEG (theta and alpha wave power) test will be performed'}, {'measure': 'Change in neurotrophin levels', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'To evaluate neurotrophin levels in blood serum tests will be performed: BDNF (pg/ml), Neurotrphin 3 and 4 (pg/ml), NGF (pg/ml)'}, {'measure': 'Change in food intake regulators:', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'To evaluate food intake regulators in blood serum tests will be performed: leptin (pg/ml), visfatin (pg/ml)'}, {'measure': 'Body composition changes 1', 'timeFrame': 'The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)', 'description': 'To evaluate body composition changes BIA body composition analysis will be performed: Body weight (kg)'}, {'measure': 'Body composition changes 2', 'timeFrame': 'The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)', 'description': 'To evaluate body composition changes BIA body composition analysis will be performed: Intracellular and extracellular water (l/%)'}, {'measure': 'Body composition changes 3', 'timeFrame': 'The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)', 'description': 'To evaluate body composition changes BIA body composition analysis will be performed: Lean body mass (kg/%)'}, {'measure': 'Body composition changes 4', 'timeFrame': 'The test will be performed three times: Before stimulation, baseline (V1), immediately after stimulation (V2) and two weeks after the intervention (V3)', 'description': 'To evaluate body composition changes BIA body composition analysis will be performed: Fat mass (kg/%)'}, {'measure': 'Changes in HPA axis biomarker', 'timeFrame': 'The test will be performed two times: Before stimulation, baseline (V1) and immediately after stimulation (V2)', 'description': 'To evaluate HPA axis cortisol (nmol/l) in blood serum will be tested'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anorexia Nervosa', 'Brain stimulation', 'Eating disorders', 'Left dorsolateral prefrontal cortex', 'Transcranial direct current stimulation'], 'conditions': ['Anorexia Nervosa']}, 'referencesModule': {'references': [{'pmid': '38757134', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nResults 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.\n\nThe 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.\n\nTo 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed written Informed Consent Form,\n* Patients aged 10-30 years old,\n* Meet the DSM-5 criteria for AN,\n* Body mass index (BMI) ≤ 17,5 kg/m2,\n* A willingness and motivation to follow the study protocol.\n\nExclusion Criteria:\n\n* Not giving Informed, Written Consent\n* Diagnosis of neurological diseases, as epilepsy;\n* Contraindications to tDCS, ie. pacemakers, metal parts around the head;\n* Psychiatric comorbidities (except specific personality disorder) including mental retardation, organic brain dysfunction, or addiction (except nicotine and caffeine);\n* Pregnancy or pregnancy planning;\n* Changes in psychopharmacotherapy during hospitalization'}, 'identificationModule': {'nctId': 'NCT05814458', 'briefTitle': 'The Efficiency of Transcranial Direct Current Stimulation in the Treatment of Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Lublin'}, 'officialTitle': 'The Efficiency of Transcranial Direct Current Stimulation in the Treatment of Anorexia Nervosa - a Randomised, Double-blind Clinical Trial', 'orgStudyIdInfo': {'id': 'KE-0254/24/01/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'tDCS group', 'description': 'The tDCS group will receive the active brain stimulation.', 'interventionNames': ['Device: tDCS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo group', 'description': 'The placebo group will receive the sham brain stimulation.', 'interventionNames': ['Device: Placebo']}], 'interventions': [{'name': 'tDCS', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['tDCS group']}, {'name': 'Placebo', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20-439', 'city': 'Lublin', 'state': 'Lublin Voivodeship', 'country': 'Poland', 'facility': 'Ist Department of Psychiatry, Psychotherapy and Early Intervention', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}], 'overallOfficials': [{'name': 'Hanna Karakuła-Juchnowicz, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': '1st Department of Psychiatry, Psychotherapy and Early Intervention, Medical University of Lublin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Lublin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}