Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-05-24 @ 12:04 PM
Study NCT ID:
NCT03094520
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2017-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Embodiment Activation by tDCS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-10', 'studyFirstSubmitDate': '2017-02-24', 'studyFirstSubmitQcDate': '2017-03-23', 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'response time in semantic decision task', 'timeFrame': 'assessed during stimulation or sham stimulation of semantic decision task (last approximately 10 min) at specific timepoint within 2 weeks', 'description': 'Comparing response time in semantic decision task under anodal tDCS compared to sham stimulation (change from sham stimulation)'}, {'measure': 'performance in attentional load task', 'timeFrame': 'assessed during stimulation or sham stimulation of attentional load task (last approximately 6 min) at specific timepoint within 2 weeks', 'description': 'Attentional load task: Participants are presented with a 6 positions ring that includes different shapes, they have to press V when they see a square and N when they see a diamond. They will have to ignore any shapes other than square and diamond within the ring or distractors that appear outside the ring.\n\nComparing performance in attentional load task under anodal tDCS compared to sham stimulation (change from sham stimulation)'}, {'measure': 'performance in motor task', 'timeFrame': 'assessed during stimulation or sham stimulation of motor task (last approximately 4 min) at specific timepoint within 2 weeks', 'description': 'Motor Task: Participants are presented with a red Box and they have to click a button each time they see it as fast as they can.\n\nComparing performance in motor task under anodal tDCS compared to sham stimulation (change from sham stimulation)'}], 'secondaryOutcomes': [{'measure': 'Functional connectivity predictors', 'timeFrame': 'assessed during baseline testing', 'description': 'Connectivity as measured by resting-state fMRI during baseline as predictors for performance and tDCS responsiveness'}, {'measure': 'Other cognitive outcomes: change in working memory performance', 'timeFrame': 'change in working memory performance from baseline after 30 min (approximately)', 'description': 'Digit span backward performance assessed before (baseline) and after stimulation to test for tDCS effects on working memory'}, {'measure': 'Other cognitive outcomes: change in Attention performance', 'timeFrame': 'change in attention performance from baseline after 30 min (approximately)', 'description': 'Digit span forward performance assessed before baseline) and after stimulation to test for tDCS effects on attention'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Young Adults']}, 'referencesModule': {'references': [{'pmid': '25558040', 'type': 'BACKGROUND', 'citation': 'Cohen-Maximov T, Avirame K, Floel A, Lavidor M. Modulation of Gestural-verbal Semantic Integration by tDCS. Brain Stimul. 2015 May-Jun;8(3):493-8. doi: 10.1016/j.brs.2014.12.001. Epub 2014 Dec 11.'}, {'pmid': '12911767', 'type': 'BACKGROUND', 'citation': 'Floel A, Ellger T, Breitenstein C, Knecht S. Language perception activates the hand motor cortex: implications for motor theories of speech perception. Eur J Neurosci. 2003 Aug;18(3):704-8. doi: 10.1046/j.1460-9568.2003.02774.x.'}, {'pmid': '18303984', 'type': 'BACKGROUND', 'citation': 'Floel A, Rosser N, Michka O, Knecht S, Breitenstein C. Noninvasive brain stimulation improves language learning. J Cogn Neurosci. 2008 Aug;20(8):1415-22. doi: 10.1162/jocn.2008.20098.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the proposed research is to extend our understanding of how gesture and language interact, focusing on the role of cognitive embodiment in this interaction, and to explore the neural systems that support links between language and actions systems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Right handedness\n* unobtrusive neuropsychological screening\n\nExclusion Criteria:\n\n* History of severe alcoholism or use of drugs.\n* Severe psychiatric disorders such as depression, psychosis (if not in remission) and severe untreated medical problems.\n* Contraindication for MRT (claustrophobia, metallic implants, ferromagnetic metals in the body, disorders of thermoregulation, pregnant women).'}, 'identificationModule': {'nctId': 'NCT03094520', 'acronym': 'GEST', 'briefTitle': 'Cognitive Embodiment Activation by tDCS', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Effects of Transcranial Direct Current Stimulation (tDCS) on Gestural-verbal Brain Associations: the Role of Cognitive Embodiment', 'orgStudyIdInfo': {'id': 'GEST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anodal tDCS + semantic, motor, attentional tasks', 'description': 'Combination of gestural (subjects have to indicate if the gesture is related to the word), attentional and motor tasks with anodal stimulation', 'interventionNames': ['Device: tDCS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS + semantic, motor, attentional tasks', 'description': 'Combination of gestural (subjects have to indicate if the gesture is related to the word), attentional and motor tasks with sham stimulation', 'interventionNames': ['Device: sham-tDCS']}], 'interventions': [{'name': 'tDCS', 'type': 'DEVICE', 'otherNames': ['Neuroconn'], 'description': 'Transcranial direct current stimulation (tDCS)', 'armGroupLabels': ['Anodal tDCS + semantic, motor, attentional tasks']}, {'name': 'sham-tDCS', 'type': 'DEVICE', 'otherNames': ['Neuroconn'], 'description': 'sham stimulation', 'armGroupLabels': ['Sham tDCS + semantic, motor, attentional tasks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Agnes Floeel, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite Universitätsmedizin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.Dr.med.', 'investigatorFullName': 'Agnes Flöel', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}