Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT03882502
Status:
UNKNOWN
Last Update Posted:
2020-02-07
First Post:
2019-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electrical Stimulation in Traumatic Brain Injury (TBI) Induced Aphasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001037', 'term': 'Aphasia'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D013064', 'term': 'Speech Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'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'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, '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': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-06', 'studyFirstSubmitDate': '2019-03-18', 'studyFirstSubmitQcDate': '2019-03-18', 'lastUpdatePostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Naming ability assessed by', 'timeFrame': '2 weeks', 'description': 'Performance in a standardised naming task (Boston Naming Task, BNT) under anodal tDCS compared to sham assessed immediately after training period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aphasia', 'TBI (Traumatic Brain Injury)', 'tDCS']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate whether a tDCS-accompanied intensive naming therapy leads to a performance improvement in patients with chronic aphasia induced by a moderate TBI'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aphasia assessed by Aachener Aphasie Test (AAT) \\> 6 month after moderate TBI\n* Age: 18 - 80 years\n* right handedness\n\nExclusion Criteria:\n\n* dementia or other neurological diseases\n* History of severe alcoholism or use of drugs\n* Severe psychiatric disorders such as depression, psychosis (if not in remission)\n* Severe untreated medical problems such as cancer'}, 'identificationModule': {'nctId': 'NCT03882502', 'briefTitle': 'Electrical Stimulation in Traumatic Brain Injury (TBI) Induced Aphasia', 'organization': {'class': 'OTHER', 'fullName': 'University Medicine Greifswald'}, 'officialTitle': 'The Effect of Transcranial Direct Current Stimulation (tDCS) on Naming Ability in Patients With Traumatic Brain Injury Induced Aphasia', 'orgStudyIdInfo': {'id': 'BISCUIT Trial 2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'stimulation group', 'interventionNames': ['Other: anodal transcranial direct current stimulation (tDCS)- accompanied naming therapy or sham stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham stimulation', 'interventionNames': ['Other: anodal transcranial direct current stimulation (tDCS)- accompanied naming therapy or sham stimulation']}], 'interventions': [{'name': 'anodal transcranial direct current stimulation (tDCS)- accompanied naming therapy or sham stimulation', 'type': 'OTHER', 'description': 'anodal tDCS or sham stimulation will be combined with an intensive naming training and the number of items that could be named will be assessed immediately after the intervention.', 'armGroupLabels': ['sham stimulation', 'stimulation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17475', 'city': 'Greifswald', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Agnes Floeel, Prof', 'role': 'CONTACT', 'email': 'agnes.floeel@uni-greifswald.de', 'phone': '+49 3834 86 6815'}, {'name': 'Katharina Wuesten, PhD', 'role': 'CONTACT', 'email': 'Katharina.wuesten@uni-greifswald.de', 'phone': '+49 3834 86 6754'}], 'facility': 'University medicine Greifswald', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}], 'centralContacts': [{'name': 'Agnes Floeel, Prof', 'role': 'CONTACT', 'email': 'agnes.floeel@uni-greifswald.de', 'phone': '+49 3834 86 6815'}, {'name': 'Katharina Wuesten, PhD', 'role': 'CONTACT', 'email': 'katharina.wuesten@uni-greifswald.de', 'phone': '+49 3834 86 6754'}], 'overallOfficials': [{'name': 'Agnes Floeel, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medicine Greifswald'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medicine Greifswald', 'class': 'OTHER'}, 'collaborators': [{'name': 'P.A.N.-Zentrum', 'class': 'OTHER'}, {'name': 'Unfallkrankenhaus Berlin', 'class': 'OTHER'}, {'name': 'Kliniken Beelitz GmbH', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}