Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-31 @ 1:10 PM
Study NCT ID:
NCT04019028
Status:
COMPLETED
Last Update Posted:
2020-02-27
First Post:
2019-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-time Monitoring of Motor Cortical Activity Induced by Low-frequency Repetitive Transcranial Magnetic Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-25', 'studyFirstSubmitDate': '2019-07-11', 'studyFirstSubmitQcDate': '2019-07-11', 'lastUpdatePostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of Cortical activation', 'timeFrame': 'Baseline and after intervention[Immediately after 20 minutes of intervention]', 'description': 'Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) before and after stimulation'}], 'secondaryOutcomes': [{'measure': 'Changes in motor evoked potentia', 'timeFrame': 'Baseline and after intervention[Immediately after 20 minutes of intervention]', 'description': 'measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle.'}, {'measure': 'changes in nine hole peg test', 'timeFrame': 'Baseline and after intervention[Immediately after 20 minutes of intervention]', 'description': 'Nine-Hole Peg Test is used to measure finger dexterity in patients with various neurological diagnoses.'}, {'measure': 'Sequential motor task', 'timeFrame': 'Baseline and after intervention[Immediately after 20 minutes of intervention]', 'description': 'It is a training exercise in which five digits are repeatedly pressed with five fingers using individual movements, and it is trained to press the button accurately and quickly.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['low frequency rTMS', 'fNIRS', 'Hemodynamic Response', 'Non-invasive brain stimulation'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'In this study, we investigated the effect of low-frequency repetitive trans cranial magnetic stimulation, one of the noninvasive brain stimuli, on the functional changes of the bilateral motor cortical activity in normal subjects using functional near infrared spectroscopy (fNIRS).', 'detailedDescription': 'In normal subjects,\n\n1. the effect of low-frequency repetitive transcranial magnetic stimulation on cerebral cortex are measured in real time using fNIRS.\n2. Changes in cerebral cortical activity before and after stimulation are measured using the motor function test and the motor-induced potential test'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult men and women without history of central nervous system disease and abnormalities\n\nExclusion Criteria:\n\n* Under 18 years old, 70 years old or older\n* A person who has inserted a metal object in a skull\n* A person with complete occlusion of the carotid artery\n* A person with epilepsy\n* Pregnant and lactating women\n* Who is not eligible for the test'}, 'identificationModule': {'nctId': 'NCT04019028', 'briefTitle': 'Real-time Monitoring of Motor Cortical Activity Induced by Low-frequency Repetitive Transcranial Magnetic Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Real-time Monitoring of Motor Cortical Activity Induced by Low-frequency Repetitive Transcranial Magnetic Stimulation: Functional Near Infrared Spectroscopic Study', 'orgStudyIdInfo': {'id': '2014-05-021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Navigated low frequency rTMS', 'description': "Application of 1Hz low frequency repetitive transcranial magnetic stimulation to the primary motor area of the dominant hemisphere using a navigation system.\n\nUsing the BrainSight instrument, a navigation system, the TMS coil position can be fixed on the point precise target area based on the subject's MRI image.", 'interventionNames': ['Device: low frequency rTMS + Navigation System']}, {'type': 'EXPERIMENTAL', 'label': 'only low frequency rTMS(not using Navigation System)', 'description': 'Application of low frequency repetitive transcranial magnetic stimulation to the primary motor area of the dominant hemisphere not using a navigation system.\n\nTMS coil is fixed on the target area based on MEP hotspot.', 'interventionNames': ['Device: only low frequency rTMS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Navigated Sham rTMS', 'description': "Application of repetitive transcranial magnetic stimulation with sham mode(no stimulation) to the primary motor area of the dominant hemisphere using a navigation system.\n\nUsing the BrainSight instrument, a navigation system, the TMS coil position can be fixed on the point precise target area based on the subject's MRI image.\n\nSham stimulation is stimulated by the same frequency, intensity and time as the actual stimulus in such a way that the 8-shaped coil is placed at a 90 degree angle to the scalp in the same manner as rTMS and sounds are heard but the magnetic stimulus is not transmitted to the cerebrum", 'interventionNames': ['Device: Sham low frequency rTMS + Navigation System']}], 'interventions': [{'name': 'low frequency rTMS + Navigation System', 'type': 'DEVICE', 'description': '1Hz low-frequency rTMS stimulation over primary motor area using navigation system', 'armGroupLabels': ['Navigated low frequency rTMS']}, {'name': 'only low frequency rTMS', 'type': 'DEVICE', 'description': '1Hz low-frequency rTMS stimulation over primary motor area', 'armGroupLabels': ['only low frequency rTMS(not using Navigation System)']}, {'name': 'Sham low frequency rTMS + Navigation System', 'type': 'DEVICE', 'description': '1Hz low-frequency sham rTMS stimulation over primary motor area using navigation system', 'armGroupLabels': ['Navigated Sham rTMS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yun-Hee Kimm, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, PhD', 'investigatorFullName': 'Yun-Hee Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}