Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-30 @ 9:01 PM
Study NCT ID:
NCT04873804
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2021-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Transcranial Direct Stimulation on Cognitive Functions of Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-04', 'studyFirstSubmitDate': '2021-04-14', 'studyFirstSubmitQcDate': '2021-05-04', 'lastUpdatePostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuropsychiatric Test Battery', 'timeFrame': '3 weeks', 'description': 'It is a test battery for getting detailed information about general cognitive status.'}, {'measure': 'Beck Depression Scale', 'timeFrame': '3 weeks', 'description': 'It measures the symptoms seen in depression such as emotional, cognitive and motivational. It includes 21 items determine a behavioral feature related to depression. Items are numbered from 0 to 3. The goal is to objectively break down the degree of symptoms.\n\nThe total score of all answers is calculated as follows:\n\n0 to 9 points: Minimally depressive symptoms 10 to 16 points: Mild depressive symptoms Between 17 and 29 points: Moderate depressive symptoms Between 30 and 63 points: Severe depressive symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tDCS', 'Dorsolateral Prefrontal Cortex', 'Posterior Parietal Cortex', 'Cognitive Function'], 'conditions': ['Cognitive Symptom', 'Healthy']}, 'descriptionModule': {'briefSummary': 'Background: Transcranial direct current stimulation(tDCS) has been used to improve cognitive functions in healthy young adults.\n\nPurpose: To investigate the effect of TDCS application on different cortex regions on cognitive function.\n\nMethods: Sixty individuals aged 18-30 were included in the study. The participants were randomly divided into the left dorsolateral prefrontal cortex (Left DLPFC Group)(n=20), the right posterior parietal cortex (Right PPC Group)(n=20), and the sham group (Sham Group)(n=20). tDCS was applied for 20 minutes on weekdays for 2 weeks. The participants were evaluated in terms of cognitive functions with Neuropsychometric Test Battery before and after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being 18-30 years old\n\nExclusion Criteria:\n\n* alcohol and substance addiction\n* previous mental illness\n* having mental and cognitive problems\n* a history of head trauma\n* having cardiovascular disease.'}, 'identificationModule': {'nctId': 'NCT04873804', 'briefTitle': 'The Effect of Transcranial Direct Stimulation on Cognitive Functions of Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'The Effect Of Transcranial Direct Stimulation Applied To The Dorsolateral Prefrontal Cortex And Posterior Parietal Cortex İn Cognitive Function, Mood And Proprioception İn Healthy Adults', 'orgStudyIdInfo': {'id': 'tDCS on DLPFC and PPC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LEFT DLPFC', 'description': 'The anode electrode of tDCS was applied to the left DLPFC and the cathode electrode was connected to the contralateral shoulder.', 'interventionNames': ['Other: Transcranial Direct Current Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RİGHT PPC', 'description': 'The anode electrode of tDCS was applied to the right PPC and the cathode electrode was connected to the contralateral shoulder.', 'interventionNames': ['Other: Transcranial Direct Current Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'Placebo was applied by placing the electrodes in the right PPC and left DLPFC without applying current.', 'interventionNames': ['Other: Transcranial Direct Current Stimulation']}], 'interventions': [{'name': 'Transcranial Direct Current Stimulation', 'type': 'OTHER', 'description': 'The intervention protocols were applied using tDCS (Teknofil TESsaNova). All individuals received 2 mA of anodal tDCS for 2 weeks on weekdays. All applications were done in the form of 20-minute sessions.', 'armGroupLabels': ['LEFT DLPFC', 'RİGHT PPC', 'Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Damla Ören', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34000', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Medipol Mega Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Miray Budak, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medipol University'}, {'name': 'Lutfu Hanoglu, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medipol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist MSc', 'investigatorFullName': 'Damla Ören', 'investigatorAffiliation': 'Medipol University'}}}}