Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-04 @ 10:04 PM
Study NCT ID:
NCT03163758
Status:
COMPLETED
Last Update Posted:
2020-06-30
First Post:
2017-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cerebral Reorganization of Stroke Patients After Repetitive Transcranial Magnetic Stimulation by Neuroimaging Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ZhangWeiHong@pumch.cn', 'phone': '01069159581', 'title': 'Dr. Weihong Zhang', 'organization': 'Peking Union Medical College Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'one month after real/sham rTMS treatment', 'description': 'The common adverse events of rTMS are headache, dizzy, scalp discomfort at the site of stimulation, tingling, spasms or twitching of facial muscles and lightheadedness. The uncommon side effects of rTMS include seizures, mania, and hearing loss.', 'eventGroups': [{'id': 'EG000', 'title': 'rTMS Treatment Group', 'description': 'The rTMS treatment group received a 10-day real repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.\n\nreal Repetitive Transcranial Magnetic Stimulation: The rTMS treatments were performed using a Medtronic MagPro type magnetic stimulation device (Medtronic, Minneapolis, MN, USA) and a figure-of-eight coil (MC-B70, Medtronic). Coils were placed tangent to the scalp. The stimulation protocol involved 50 trains of 20 pulses applied over the ipsilesional M1 at a frequency of 5 HZ, with the stimulus intensity set at 120% of the resting motor threshold of the unaffected extremity.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 2, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Group', 'description': 'The sham group received a 10-day sham repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.\n\nsham Repetitive Transcranial Magnetic Stimulation: The sham rTMS was performed on the same site as the rTMS treatment group but without any true stimulations. Coils were placed perpendicular to the scalp.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 2, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}, {'term': 'dizzy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'National Institutes of Health Stroke Scale (NIHSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rTMS Treatment Group', 'description': 'The rTMS treatment group received a 10-day real repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.\n\nreal Repetitive Transcranial Magnetic Stimulation: The rTMS treatments were performed using a Medtronic MagPro type magnetic stimulation device (Medtronic, Minneapolis, MN, USA) and a figure-of-eight coil (MC-B70, Medtronic). Coils were placed tangent to the scalp. The stimulation protocol involved 50 trains of 20 pulses applied over the ipsilesional M1 at a frequency of 5 HZ, with the stimulus intensity set at 120% of the resting motor threshold of the unaffected extremity.'}, {'id': 'OG001', 'title': 'Sham Group', 'description': 'The sham group received a 10-day sham repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.\n\nsham Repetitive Transcranial Magnetic Stimulation: The sham rTMS was performed on the same site as the rTMS treatment group but without any true stimulations. Coils were placed perpendicular to the scalp.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline NIHSS at 1 month after real rTMS/sham rTMS', 'description': "The investigators use National Institutes of Health Stroke Scale (NIHSS) to evaluate the participants' neural deficit after stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. Higher NIHSS scores mean a worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two patients lost in the follow-up of the rTMS treatment group. And three patients lost in the follow-up of the sham group.'}, {'type': 'PRIMARY', 'title': 'Barthel Index (BI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rTMS Treatment Group', 'description': 'The rTMS treatment group received a 10-day real repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.\n\nreal Repetitive Transcranial Magnetic Stimulation: The rTMS treatments were performed using a Medtronic MagPro type magnetic stimulation device (Medtronic, Minneapolis, MN, USA) and a figure-of-eight coil (MC-B70, Medtronic). Coils were placed tangent to the scalp. The stimulation protocol involved 50 trains of 20 pulses applied over the ipsilesional M1 at a frequency of 5 HZ, with the stimulus intensity set at 120% of the resting motor threshold of the unaffected extremity.'}, {'id': 'OG001', 'title': 'Sham Group', 'description': 'The sham group received a 10-day sham repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.\n\nsham Repetitive Transcranial Magnetic Stimulation: The sham rTMS was performed on the same site as the rTMS treatment group but without any true stimulations. Coils were placed perpendicular to the scalp.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.6', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '6.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline BI at 1 month after real rTMS/sham rTMS', 'description': "The investigators use Barthel Index (BI) to evaluate the participants' activities of daily living after stroke. The BI consists of 10 questions that relate to degree of independence with activities of daily living, including toileting, bathing, eating, dressing, continence, transfers, and ambulation. The BI score is calculated by summing the response value to each of the 10 questions. The BI score ranges from 0 to 100. A patient scoring 0 points would be dependent in all assessed activities of daily living, whereas a score of 100 would reflect independence in these activities. A higher score is associated with a better outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two patients lost in the follow-up of the rTMS treatment group. And three patients lost in the follow-up of the sham group.'}, {'type': 'PRIMARY', 'title': 'Fugl-Meyer Assessment Upper Limb (FMA-UL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rTMS Treatment Group', 'description': 'The rTMS treatment group received a 10-day real repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.\n\nreal Repetitive Transcranial Magnetic Stimulation: The rTMS treatments were performed using a Medtronic MagPro type magnetic stimulation device (Medtronic, Minneapolis, MN, USA) and a figure-of-eight coil (MC-B70, Medtronic). Coils were placed tangent to the scalp. The stimulation protocol involved 50 trains of 20 pulses applied over the ipsilesional M1 at a frequency of 5 HZ, with the stimulus intensity set at 120% of the resting motor threshold of the unaffected extremity.'}, {'id': 'OG001', 'title': 'Sham Group', 'description': 'The sham group received a 10-day sham repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.\n\nsham Repetitive Transcranial Magnetic Stimulation: The sham rTMS was performed on the same site as the rTMS treatment group but without any true stimulations. Coils were placed perpendicular to the scalp.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '11.1', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline FMA at 1 month after real rTMS/sham rTMS', 'description': "The investigators use Fugl-Meyer assessment Upper Limb (FMA-UL) to evaluate the participants' motor function of upper limb. The FMA-UL is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. The maximum score of FMA-UL is 66 and the minimum score is 0. Higher scores mean a better outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two patients lost in the follow-up of the rTMS treatment group. And three patients lost in the follow-up of the sham group.'}, {'type': 'SECONDARY', 'title': 'Functional Connectivity Map (FC Map)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rTMS Treatment Group', 'description': 'The rTMS treatment group received a 10-day real repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.\n\nreal Repetitive Transcranial Magnetic Stimulation: The rTMS treatments were performed using a Medtronic MagPro type magnetic stimulation device (Medtronic, Minneapolis, MN, USA) and a figure-of-eight coil (MC-B70, Medtronic). Coils were placed tangent to the scalp. The stimulation protocol involved 50 trains of 20 pulses applied over the ipsilesional M1 at a frequency of 5 HZ, with the stimulus intensity set at 120% of the resting motor threshold of the unaffected extremity.'}, {'id': 'OG001', 'title': 'Sham Group', 'description': 'The sham group received a 10-day sham repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.\n\nsham Repetitive Transcranial Magnetic Stimulation: The sham rTMS was performed on the same site as the rTMS treatment group but without any true stimulations. Coils were placed perpendicular to the scalp.'}], 'timeFrame': 'Change from Baseline z-FC maps at 1 month after real rTMS/sham rTMS', 'description': "Functional Connectivity was examined using a seed-based voxel-wise correlation approach. The ipsilesional primary motor cortex (M1) was defined as the region of interest. Pearson's correlation analysis between the time course of the ipsilesional M1 and that of every voxel in the whole brain was computed for a map of correlation coefficients, which were Fisher's z-transformed and called as z-FC maps.", 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measurement, the z-FC map, is not numeric data. Z-FC map is a radiographic imaging measurement. The study compared the difference of the z-FC map between the rTMS treatment group and the sham group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'rTMS Treatment Group', 'description': 'The rTMS treatment group received a 10-day real repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.\n\nreal Repetitive Transcranial Magnetic Stimulation: The rTMS treatments were performed using a Medtronic MagPro type magnetic stimulation device (Medtronic, Minneapolis, MN, USA) and a figure-of-eight coil (MC-B70, Medtronic). Coils were placed tangent to the scalp. The stimulation protocol involved 50 trains of 20 pulses applied over the ipsilesional M1 at a frequency of 5 HZ, with the stimulus intensity set at 120% of the resting motor threshold of the unaffected extremity.'}, {'id': 'FG001', 'title': 'Sham Group', 'description': 'The sham group received a 10-day sham repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.\n\nsham Repetitive Transcranial Magnetic Stimulation: The sham rTMS was performed on the same site as the rTMS treatment group but without any true stimulations. Coils were placed perpendicular to the scalp.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Acute ischemic stroke inpatients from the department of Neurology in Peking Union Medical College Hospital were enrolled.', 'preAssignmentDetails': "Ten participants were excluded from the study because they didn't meet the inclusion criteria."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'rTMS Treatment Group', 'description': 'The rTMS treatment group received a 10-day real repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.\n\nreal Repetitive Transcranial Magnetic Stimulation: The rTMS treatments were performed using a Medtronic MagPro type magnetic stimulation device (Medtronic, Minneapolis, MN, USA) and a figure-of-eight coil (MC-B70, Medtronic). Coils were placed tangent to the scalp. The stimulation protocol involved 50 trains of 20 pulses applied over the ipsilesional M1 at a frequency of 5 HZ, with the stimulus intensity set at 120% of the resting motor threshold of the unaffected extremity.'}, {'id': 'BG001', 'title': 'Sham Group', 'description': 'The sham group received a 10-day sham repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.\n\nsham Repetitive Transcranial Magnetic Stimulation: The sham rTMS was performed on the same site as the rTMS treatment group but without any true stimulations. Coils were placed perpendicular to the scalp.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.7', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '57.4', 'spread': '14.0', 'groupId': 'BG001'}, {'value': '58.5', 'spread': '11.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-01-01', 'size': 170448, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-25T03:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-13', 'studyFirstSubmitDate': '2017-02-20', 'resultsFirstSubmitDate': '2019-07-13', 'studyFirstSubmitQcDate': '2017-05-20', 'lastUpdatePostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-13', 'studyFirstPostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'National Institutes of Health Stroke Scale (NIHSS)', 'timeFrame': 'Change from Baseline NIHSS at 1 month after real rTMS/sham rTMS', 'description': "The investigators use National Institutes of Health Stroke Scale (NIHSS) to evaluate the participants' neural deficit after stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. Higher NIHSS scores mean a worse outcome."}, {'measure': 'Barthel Index (BI)', 'timeFrame': 'Change from Baseline BI at 1 month after real rTMS/sham rTMS', 'description': "The investigators use Barthel Index (BI) to evaluate the participants' activities of daily living after stroke. The BI consists of 10 questions that relate to degree of independence with activities of daily living, including toileting, bathing, eating, dressing, continence, transfers, and ambulation. The BI score is calculated by summing the response value to each of the 10 questions. The BI score ranges from 0 to 100. A patient scoring 0 points would be dependent in all assessed activities of daily living, whereas a score of 100 would reflect independence in these activities. A higher score is associated with a better outcome."}, {'measure': 'Fugl-Meyer Assessment Upper Limb (FMA-UL)', 'timeFrame': 'Change from Baseline FMA at 1 month after real rTMS/sham rTMS', 'description': "The investigators use Fugl-Meyer assessment Upper Limb (FMA-UL) to evaluate the participants' motor function of upper limb. The FMA-UL is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. The maximum score of FMA-UL is 66 and the minimum score is 0. Higher scores mean a better outcome."}], 'secondaryOutcomes': [{'measure': 'Functional Connectivity Map (FC Map)', 'timeFrame': 'Change from Baseline z-FC maps at 1 month after real rTMS/sham rTMS', 'description': "Functional Connectivity was examined using a seed-based voxel-wise correlation approach. The ipsilesional primary motor cortex (M1) was defined as the region of interest. Pearson's correlation analysis between the time course of the ipsilesional M1 and that of every voxel in the whole brain was computed for a map of correlation coefficients, which were Fisher's z-transformed and called as z-FC maps."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ischemic stroke', 'Functional magnetic resonance imaging (fMRI)', 'Repetitive transcranial magnetic stimulation (rTMS)', 'Brain Reorganization'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '30140207', 'type': 'DERIVED', 'citation': 'Li J, Zuo Z, Zhang X, Shao X, Lu J, Xue R, Fan Y, Guan Y, Zhang W. Excitatory Repetitive Transcranial Magnetic Stimulation Induces Contralesional Cortico-Cerebellar Pathways After Acute Ischemic Stroke: A Preliminary DTI Study. Front Behav Neurosci. 2018 Jul 27;12:160. doi: 10.3389/fnbeh.2018.00160. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'The study aimed to figure out brain structural and functional reorganization evidence after repetitive transcranial magnetic stimulation through the method of neuroimaging brain network analysis, such as resting-state functional magnetic resonance imaging and diffusion tensor imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. stroke patients within 1 week after onset with unilateral cerebral subcortex lesion in the middle cerebral artery territory detected by diffusion weighted image,\n2. right-handed,\n3. without memory loss or intelligence disorder,\n4. never suffered stroke before.\n\nExclusion Criteria:\n\n1. direct damage to the cerebral cortex,\n2. a history of cerebral vessel disease,\n3. tendency to hemorrhage or existed brain hemorrhage,\n4. epilepsy or other mental disorders,\n5. any MRI contraindications.'}, 'identificationModule': {'nctId': 'NCT03163758', 'briefTitle': 'Cerebral Reorganization of Stroke Patients After Repetitive Transcranial Magnetic Stimulation by Neuroimaging Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Study of Cerebral Structural and Functional Reorganization of Stroke Patients After Repetitive Transcranial Magnetic Stimulation (rTMS) Using the Method of Neuroimaging Brain Network Analysis', 'orgStudyIdInfo': {'id': 'NNSFC-81271545'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rTMS treatment group', 'description': 'The rTMS treatment group received a 10-day real repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.', 'interventionNames': ['Device: real Repetitive Transcranial Magnetic Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham group', 'description': 'The sham group received a 10-day sham repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.', 'interventionNames': ['Device: sham Repetitive Transcranial Magnetic Stimulation']}], 'interventions': [{'name': 'real Repetitive Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'description': 'The rTMS treatments were performed using a Medtronic MagPro type magnetic stimulation device (Medtronic, Minneapolis, MN, USA) and a figure-of-eight coil (MC-B70, Medtronic). Coils were placed tangent to the scalp. The stimulation protocol involved 50 trains of 20 pulses applied over the ipsilesional M1 at a frequency of 5 HZ, with the stimulus intensity set at 120% of the resting motor threshold of the unaffected extremity.', 'armGroupLabels': ['rTMS treatment group']}, {'name': 'sham Repetitive Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'description': 'The sham rTMS was performed on the same site as the rTMS treatment group but without any true stimulations. Coils were placed perpendicular to the scalp.', 'armGroupLabels': ['sham group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese Academy of Sciences', 'class': 'OTHER_GOV'}, {'name': 'University of Pennsylvania', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}