Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-03-11 @ 2:10 AM
Study NCT ID:
NCT03273205
Status:
COMPLETED
Last Update Posted:
2021-02-17
First Post:
2017-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Direct Current Stimulation (tDCS) 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'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2017-09-01', 'studyFirstSubmitQcDate': '2017-09-02', 'lastUpdatePostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of the Eating Disorders Examination Questionnaire (EDEq) score', 'timeFrame': '8 weeks', 'description': 'Comparison of the total scores and subscores of the Eating Disorders Examination Questionnaire (EDEq)'}], 'secondaryOutcomes': [{'measure': 'Change of the Zung Self-Rating Depression Scale', 'timeFrame': '8 weeks', 'description': 'Comparison of the total scores of the Zung Self-Rating Depression Scale'}, {'measure': 'Change of the pain threshold', 'timeFrame': '8 weeks', 'description': 'Measurement of the pain threshold with the TSA II Neuro Sensory Analyzer'}, {'measure': 'Change of the weight in kilograms', 'timeFrame': '8 weeks', 'description': 'Regularly weighting on the scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcranial direct current stimulation (tDCS)'], 'conditions': ['Anorexia Nervosa']}, 'referencesModule': {'references': [{'pmid': '34690831', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nTranscranial 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.\n\nThe 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.\n\nThere 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.', 'detailedDescription': '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.\n\nAll measurements and questionnaires are made 4 times:\n\n1. Before the stimulation\n2. On the day of the last stimulation\n3. 14 days after the last stimulation\n4. 28 days after the last stimulation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with the diagnosis of anorexia nervosa\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT03273205', 'acronym': 'SANO', 'briefTitle': 'Transcranial Direct Current Stimulation (tDCS) in the Treatment of Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'The Changes in the Body-perception and Perception of the Pain in Patients With Anorexia Nervosa Before and After Using the tDCS', 'orgStudyIdInfo': {'id': '1955/16 S-IV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anodal tDCS', 'description': 'The first group of patients has the real stimulation and the electrodes are placed in this position:\n\nAnode: Left DLPFC \\[F3) Cathode: Right Supraorbital (FP2)', 'interventionNames': ['Device: Anodal tDCS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS', 'description': 'The second group has the sham stimulation, but the electrodes are placed in the same position as in the first group:\n\nAnode: Left DLPFC \\[F3) Cathode: Right Supraorbital (FP2)', 'interventionNames': ['Device: Sham tDCS']}], 'interventions': [{'name': 'Anodal tDCS', 'type': 'DEVICE', 'description': 'This group gets a real stimulation', 'armGroupLabels': ['Anodal tDCS']}, {'name': 'Sham tDCS', 'type': 'DEVICE', 'description': 'This group gets a sham stimulation', 'armGroupLabels': ['Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '121 08', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Department of Psychiatry, Charles University in Prague and General University Hospital in Prague', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Hana Papezova, Prof.,M.D.,CSc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Psychiatry, Charles University in Prague and General University Hospital in Prague'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Silvie Ceresnakova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Silvie Ceresnakova', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}