Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-28 @ 6:24 PM
Study NCT ID:
NCT00396058
Status:
TERMINATED
Last Update Posted:
2008-03-27
First Post:
2006-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Methylphenidate on Motor Learning in Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 13}}, 'statusModule': {'whyStopped': 'Recruitment of patients proved much too difficult based on the chosen criteria.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-26', 'studyFirstSubmitDate': '2006-11-03', 'studyFirstSubmitQcDate': '2006-11-03', 'lastUpdatePostDateStruct': {'date': '2008-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Training induced changes in Short interval Intracortical Inhibition (SICI).'}, {'measure': 'Training induced changes in Intracortical facilitation (ICF)'}], 'secondaryOutcomes': [{'measure': 'Baseline SICI, ICF, and motor threshold compared between methylphenidate and Placebo'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cerebrovascular Accident']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether methylphenidate facilitates so called short-term plasticity as measures with transcranial magnetic stimulation, in patients with stroke.', 'detailedDescription': 'Stroke patients are to be examined with transcranial magnetic stimulation (TMS) before and after a short training session. TMS will be used to demonstrate changes in cortical excitability (motor threshold) and intracortical inhibition and facilitation. The effect of methylphenidate on baseline TMS measures will be evaluated as well as the effect on training induced changes in TMS measures (by comparing baseline and posttraining measures). The patients will be trained on two separate occasions, to compare the effect of Methylphenidate to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Less than two months after first stroke.\n* Moderate to light hand paralysis\n* Measurable MEP in the abductor pollicis brevis muscle\n* Able to read and understand the written information\n* Signed informed consent\n\nExclusion Criteria:\n\n* Epilepsy\n* Glaucoma\n* Hyperthyroidism\n* Cardiac arrythmia\n* Known heart disease or angina.\n* Metal implants\n* Pacemaker\n* Pregnancy\n* Diastolic BP\\>100 mmHg\n* In treatment with MAO-inhibitor, SSRIs og Ritalin'}, 'identificationModule': {'nctId': 'NCT00396058', 'briefTitle': 'The Effect of Methylphenidate on Motor Learning in Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Methylphenidats Betydning for motoriskindlæring Hos Patienter Med Apopleksi', 'orgStudyIdInfo': {'id': '2006-002554-29'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Methylphenidate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'state': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of neurology', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '8450', 'city': 'Hammel', 'state': 'Hammel', 'country': 'Denmark', 'facility': 'Hammel neurocenter', 'geoPoint': {'lat': 56.25762, 'lon': 9.86316}}], 'overallOfficials': [{'name': 'Jakob U Blicher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hammel neurocenter Aarhus University Hospital Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}}}}