Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-30 @ 3:04 PM
Study NCT ID:
NCT00102856
Status:
SUSPENDED
Last Update Posted:
2010-06-24
First Post:
2005-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuromodulation and Language Acquisition (Stage Ib)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077487', 'term': 'Pramipexole'}, {'id': 'D000068836', 'term': 'Rivastigmine'}], 'ancestors': [{'id': 'D052160', 'term': 'Benzothiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D048448', 'term': 'Phenylcarbamates'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2006-06'}, 'lastUpdateSubmitDate': '2010-06-23', 'studyFirstSubmitDate': '2005-02-03', 'studyFirstSubmitQcDate': '2005-02-03', 'lastUpdatePostDateStruct': {'date': '2010-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-02-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Boost in language learning success (percent hits) through neuromodulation'}], 'secondaryOutcomes': [{'measure': 'Stability of language learning success after one week, one month, and one year'}]}, 'conditionsModule': {'keywords': ['language acquisition', 'plasticity', 'stroke recovery', 'associative learning'], 'conditions': ['Healthy']}, '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether rivastigmine or pramipexol are effective in boosting semantic language acquisition in healthy subjects.', '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 a selective d2/d3 dopamine agonist (pramipexole) or cholinergic neuromodulation (rivastigmine), after a titration period of five days, will yield a learning enhancement comparable to using levodopa in healthy subjects. The expected scientific results will strengthen the basis for transferring neuromodulatory interventions from the laboratory to stroke patients with language dysfunctions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects\n* 20-35 years old\n* Right handedness\n* Left language dominance (as assessed by functional transcranial Doppler ultrasonography \\[fTCD\\])\n\nExclusion Criteria:\n\n* Neurological/psychiatric/metabolic/cardiac disorders\n* Asthma\n* Known allergic reactions to one of the experimental drugs\n* Other drugs affecting the central nervous system\n* Leisure drug ingestion during the past 4 weeks (urine test)\n* Smoking cessation during the past 2 weeks\n* \\> 6 cups of coffee or energy drinks per day\n* \\> 10 cigarettes per day\n* \\> 50 grams of alcohol per day'}, 'identificationModule': {'nctId': 'NCT00102856', 'briefTitle': 'Neuromodulation and Language Acquisition (Stage Ib)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Neuromodulation and Language Acquisition (KS-Neuromod_01, Stage Ib)', 'orgStudyIdInfo': {'id': 'KS-NEUROMOD_01, Stage Ib'}, 'secondaryIdInfos': [{'id': 'IZKF Muenster: Kne3/074/04'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Pramipexole', 'type': 'DRUG'}, {'name': 'Rivastigmine', 'type': 'DRUG'}]}, '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'}, {'name': 'Stefan Knecht, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dept. of Neurology, University Hospital Muenster'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}}}}