Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-30 @ 2:35 PM
Study NCT ID:
NCT00102869
Status:
COMPLETED
Last Update Posted:
2013-10-07
First Post:
2005-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dopaminergic Enhancement of Learning and Memory in Aphasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2013-10-10', 'unreleaseDateUnknown': True}, {'resetDate': '2013-12-06', 'releaseDate': '2013-10-14'}, {'resetDate': '2014-01-28', 'releaseDate': '2013-12-09'}, {'resetDate': '2014-03-18', 'releaseDate': '2014-01-29'}, {'resetDate': '2014-06-04', 'releaseDate': '2014-05-20'}, {'resetDate': '2017-09-27', 'releaseDate': '2017-09-25'}], 'estimatedResultsFirstSubmitDate': '2013-10-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D001037', 'term': 'Aphasia'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007980', 'term': 'Levodopa'}], 'ancestors': [{'id': 'D004295', 'term': 'Dihydroxyphenylalanine'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014443', 'term': 'Tyrosine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-04', 'studyFirstSubmitDate': '2005-02-03', 'studyFirstSubmitQcDate': '2005-02-03', 'lastUpdatePostDateStruct': {'date': '2013-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Boost in naming performance (percent correct) through levodopa as compared to placebo', 'timeFrame': 'immediately after each treatmentphase'}, {'measure': 'Brain activity pattern in successfully trained patients', 'timeFrame': 'immediately after each treatmentphase'}], 'secondaryOutcomes': [{'measure': 'Stability of naming performance after one month and six months post treatment', 'timeFrame': 'from 1 month untill 6 months after treatment completion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['language acquisition', 'plasticity', 'stroke recovery', 'aphasia treatment', 'naming', 'levodopa', 'stroke'], 'conditions': ['Cerebrovascular Accident', 'Aphasia']}, 'referencesModule': {'references': [{'pmid': '15236398', 'type': 'BACKGROUND', 'citation': 'Knecht S, Breitenstein C, Bushuven S, Wailke S, Kamping S, Floel A, Zwitserlood P, Ringelstein EB. Levodopa: faster and better word learning in normal humans. Ann Neurol. 2004 Jul;56(1):20-6. doi: 10.1002/ana.20125.'}, {'pmid': '15114342', 'type': 'BACKGROUND', 'citation': 'Breitenstein C, Wailke S, Bushuven S, Kamping S, Zwitserlood P, Ringelstein EB, Knecht S. D-amphetamine boosts language learning independent of its cardiovascular and motor arousing effects. Neuropsychopharmacology. 2004 Sep;29(9):1704-14. doi: 10.1038/sj.npp.1300464.'}, {'pmid': '12596014', 'type': 'BACKGROUND', 'citation': 'Breitenstein C, Knecht S. [Language acquisition and statistical learning]. Nervenarzt. 2003 Feb;74(2):133-43. doi: 10.1007/s00115-002-1466-1. German.'}, {'pmid': '25588456', 'type': 'DERIVED', 'citation': 'Breitenstein C, Korsukewitz C, Baumgartner A, Floel A, Zwitserlood P, Dobel C, Knecht S. L-dopa does not add to the success of high-intensity language training in aphasia. Restor Neurol Neurosci. 2015;33(2):115-20. doi: 10.3233/RNN-140435.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether levodopa, in combination with a high frequency language training, is effective in boosting naming performance in patients with aphasia.', 'detailedDescription': 'Our prior work shows that d-amphetamine and the dopamine precursor levodopa markedly improve word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind clinical trial, we probe whether daily administration of levodopa, coupled with several hours of language training every day, will significantly improve naming abilities in patients with aphasia as compared to placebo administration. We furthermore examine with magnetic resonance imaging which brain regions need to be functionally intact for a dopaminergic improvement of language therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for patients with aphasia:\n\n* Unilateral cerebrovascular accident (stroke) in the territory of the arteria media\n* Time post onset: \\> 6 months\n* Aphasia with anomia\n* Age between 18-75 years\n* Premorbid right-handedness\n* Primary language: German\n\nExclusion Criteria for patients and healthy controls:\n\n* Known allergy to levodopa or tartrazine\n* History of medication/drug abuse\n* Acute nicotine withdrawal or \\> 15 cigarettes per day\n* \\> 6 cups/glasses of coffee, caffeine drinks or energy drinks per day\n* \\> 50 grams of alcohol per day\n* Severe hypertonia (systole \\>180 mm Hg)\n* Severe arteriosclerosis\n* Diabetes, asthma, or glaucoma\n* Severe hearing disability\n* Evidence for severe hippocampal damage\n* Premorbid depression or psychosis\n* Medication with dopamine agonists or antagonists\n* Parkinsonian symptoms\n* Changes in anticonvulsive medication during the week prior to study enrollment'}, 'identificationModule': {'nctId': 'NCT00102869', 'briefTitle': 'Dopaminergic Enhancement of Learning and Memory in Aphasia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Aphasia)', 'orgStudyIdInfo': {'id': 'LL_001, Project on aphasia'}}, 'armsInterventionsModule': {'interventions': [{'name': 'levodopa', 'type': 'DRUG', 'description': '100mg levodopa per day over 10 days/ treatment phase'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48129', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Dept. of Neurology, University Hospital Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'Caterina Breitenstein, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dept. of Neurology, University Hospital Muenster, Germany'}, {'name': 'Stefan Knecht, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dept. of Neurology, University Hospital Muenster, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Rainer Girgenrath', 'oldOrganization': 'Bundesministerium für Bildung und Forschung (BMBF)'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-10-10', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2013-10-14', 'type': 'RELEASE'}, {'date': '2013-12-06', 'type': 'RESET'}, {'date': '2013-12-09', 'type': 'RELEASE'}, {'date': '2014-01-28', 'type': 'RESET'}, {'date': '2014-01-29', 'type': 'RELEASE'}, {'date': '2014-03-18', 'type': 'RESET'}, {'date': '2014-05-20', 'type': 'RELEASE'}, {'date': '2014-06-04', 'type': 'RESET'}, {'date': '2017-09-25', 'type': 'RELEASE'}, {'date': '2017-09-27', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University Hospital Muenster'}}}}