Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-02 @ 3:47 PM
Study NCT ID:
NCT01593956
Status:
UNKNOWN
Last Update Posted:
2013-05-23
First Post:
2012-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Transcranial Direct Current Stimulation on Cortical Plasticity in Concussed Athletes
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': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'lastUpdateSubmitDate': '2013-05-22', 'studyFirstSubmitDate': '2012-05-07', 'studyFirstSubmitQcDate': '2012-05-07', 'lastUpdatePostDateStruct': {'date': '2013-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of cortical plasticity after anodal tDCS in concussed athletes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Concussed Athletes', 'Healthy Controls']}, 'referencesModule': {'references': [{'pmid': '21572090', 'type': 'BACKGROUND', 'citation': 'De Beaumont L, Tremblay S, Poirier J, Lassonde M, Theoret H. Altered bidirectional plasticity and reduced implicit motor learning in concussed athletes. Cereb Cortex. 2012 Jan;22(1):112-21. doi: 10.1093/cercor/bhr096. Epub 2011 May 13.'}, {'pmid': '21376596', 'type': 'BACKGROUND', 'citation': 'Stagg CJ, Bachtiar V, Johansen-Berg H. The role of GABA in human motor learning. Curr Biol. 2011 Mar 22;21(6):480-4. doi: 10.1016/j.cub.2011.01.069. Epub 2011 Mar 3.'}, {'pmid': '19386916', 'type': 'BACKGROUND', 'citation': "Stagg CJ, Best JG, Stephenson MC, O'Shea J, Wylezinska M, Kincses ZT, Morris PG, Matthews PM, Johansen-Berg H. Polarity-sensitive modulation of cortical neurotransmitters by transcranial stimulation. J Neurosci. 2009 Apr 22;29(16):5202-6. doi: 10.1523/JNEUROSCI.4432-08.2009."}]}, 'descriptionModule': {'briefSummary': 'Concussed athlethes have discrete decreased abilities in motor learning. Recent research could further show, that cortical plasticity, as measured by transcranial magnetic stimulation (TMS) is reduced. This is possibly due to an increased GABAergic activity, what have been found in concussed athletes by paired pulse protocols in TMS.\n\nGABAergic acitivty can be modulated by transcranial direct current stimulation (tDCS) in a polar-specific manner: anodal tDCS was able to decrease GABA, whereas cathodal tDCS increased tDCS.\n\nOur study aimes to assess the influence of anodal tDCS on cortical plsticity in concussed athlethes. We hypothesize, that anodal tDCS is able to increase cortical plsticity in concussed athlethes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* history of at least 2 sports concussion\n* age 18 - 50 years\n\nExclusion Criteria:\n\n* structural deficit on cerebral MRI\n* Epilepsy\n* neurological disorder\n* intake of CNS-active drugs'}, 'identificationModule': {'nctId': 'NCT01593956', 'briefTitle': 'Influence of Transcranial Direct Current Stimulation on Cortical Plasticity in Concussed Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Influence of Anodal Transcranial Direct Current Stimulation on Cortical Plasticity in Concussed Athletes and Healthy Volunteers', 'orgStudyIdInfo': {'id': 'EA1/021/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Concussed athletes', 'interventionNames': ['Behavioral: tDCS']}, {'type': 'OTHER', 'label': 'Healthy controls', 'interventionNames': ['Behavioral: tDCS']}], 'interventions': [{'name': 'tDCS', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Concussed athletes', 'Healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jonathan List, MD', 'role': 'CONTACT', 'email': 'Jonathan.List@charite.de', 'phone': '+40 30 450560223'}, {'name': 'Agnes Flöel, Prof.', 'role': 'CONTACT', 'email': 'agnes.floeel@charite.de', 'phone': '+40 30 450660284'}, {'name': 'Jonathan List, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Agnes Flöel, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charité - Department of neurology', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Jonathan List, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité - Department of Neurology'}, {'name': 'Agnes Flöel, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité - Department of Neurology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jonathan List', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}