Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT01005394
Status:
TERMINATED
Last Update Posted:
2015-04-16
First Post:
2009-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Navigated Transcranial Magnetic Stimulation in Monitoring Stroke Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Insufficient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-15', 'studyFirstSubmitDate': '2009-10-30', 'studyFirstSubmitQcDate': '2009-10-30', 'lastUpdatePostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'navigated transcranial magnetic stimulation examination and correlation with motor functional testing', 'timeFrame': 'Enrollment, week 2, week 4 , week 12 and week 24 post-stroke'}], 'secondaryOutcomes': [{'measure': 'Safety of navigated transcranial magnetic stimulation examination', 'timeFrame': 'each examination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The past 10 years of research in persons more than 6 months post stroke have shown certain types of rehabilitation can help "re-wire" the brain. Transcranial magnetic stimulation (TMS) can be used to monitor this re-wiring by mapping the brain\'s function (measuring brain activity). Recent research suggests that TMS can be used for both prognosis (determining future function) and to determine what type of rehabilitation therapy will work best after stroke. The purposes of this research study are to: 1) determine changes in brain activity during the first 6 months after stroke (to determine how the brain "re-wires"); 2) compare changes in recovery of motor function with changes in brain re-wiring; 3) determine the ability of TMS to "predict" functional outcome in the first 6 months after stroke.\n\nThe primary hypotheses are: 1) functional recovery will be correlated with TMS changes (as measure motor threshold (MT), motor evoked potentials (MEPs) and recruitment curves; 2) baseline TMS will predict future functional outcomes at 3 and 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 20-80 years who have suffered a unilateral ischemic stroke and who will undergo motor rehabilitation at the study center will be asked to participate in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* one sided ischemic stroke confirmed by radiology\n* 20-80 years old\n\nExclusion Criteria:\n\n* hemorrhagic stroke\n* brainstem stroke\n* cerebellar stroke\n* thalamic stroke\n* seizure with the recent stroke\n* any history of uncontrolled seizure\n* history of epilepsy\n* pregnancy or planning on getting pregnant during the next year\n* MRI incompatibility (e.g. metal implants in body)\n* recent history (past year) of alcohol and drug abuse (due to lack of follow up)\n\nOther criteria include TMS exclusions: aneurysm clips, previous surgery over motor cortex, open craniotomy'}, 'identificationModule': {'nctId': 'NCT01005394', 'briefTitle': 'Navigated Transcranial Magnetic Stimulation in Monitoring Stroke Recovery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nexstim Ltd'}, 'officialTitle': 'Acute Longitudinal Transcranial Magnetic Stimulation (TMS) After Stroke', 'orgStudyIdInfo': {'id': 'DR-NE-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Navigated TMS', 'description': 'single arm study where all subjects will be studied using the Navigated TMS device', 'interventionNames': ['Device: Navigated TMS examination']}], 'interventions': [{'name': 'Navigated TMS examination', 'type': 'DEVICE', 'otherNames': ['device: eXimia NBS system'], 'description': 'diagnostic examination using a single pulse TMS paradigm to evaluate corticospinal motor tract integrity and its evolution after stroke', 'armGroupLabels': ['Navigated TMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45216', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Drake Rehabilitation Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Kari Dunning, PhD,PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nexstim Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}