Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT03434093
Status:
WITHDRAWN
Last Update Posted:
2019-02-28
First Post:
2018-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modulation of the Parieto-frontal Communication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Investigator left NIH', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-27', 'studyFirstSubmitDate': '2018-02-14', 'studyFirstSubmitQcDate': '2018-02-14', 'lastUpdatePostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resting state functional connectivity change induced by the paired associative stimulation', 'timeFrame': 'Study completion'}], 'secondaryOutcomes': [{'measure': 'Difference in the visual angle error of a working memory task between the DLPFC-PCC and PPC-DLPFC paired associative stimulation', 'timeFrame': 'Study completion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Paired Associative Stimulation (PAS)', 'Functional Magnetic Resonance Imaging (fMRI)', 'Electrical Field Modeling', 'Working Memory'], 'conditions': ['Normal Physiology']}, 'referencesModule': {'references': [{'pmid': '27591116', 'type': 'BACKGROUND', 'citation': 'Casula EP, Pellicciari MC, Picazio S, Caltagirone C, Koch G. Spike-timing-dependent plasticity in the human dorso-lateral prefrontal cortex. Neuroimage. 2016 Dec;143:204-213. doi: 10.1016/j.neuroimage.2016.08.060. Epub 2016 Aug 31.'}, {'pmid': '23739969', 'type': 'BACKGROUND', 'citation': 'Koch G, Ponzo V, Di Lorenzo F, Caltagirone C, Veniero D. Hebbian and anti-Hebbian spike-timing-dependent plasticity of human cortico-cortical connections. J Neurosci. 2013 Jun 5;33(23):9725-33. doi: 10.1523/JNEUROSCI.4988-12.2013.'}, {'pmid': '24569831', 'type': 'BACKGROUND', 'citation': 'Ma WJ, Husain M, Bays PM. Changing concepts of working memory. Nat Neurosci. 2014 Mar;17(3):347-56. doi: 10.1038/nn.3655. Epub 2014 Feb 25.'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nResearch shows that the parietal and prefrontal areas of the brain are involved in short-term memory. Researchers want to look at the effects of transcranial magnetic stimulation (TMS) of these areas on short-term memory and brain activity. They will use functional magnetic resonance imaging (fMRI) to look at brain activity.\n\nObjective:\n\nTo look at the effects of TMS on brain pathways involved in memory.\n\nEligibility:\n\nHealthy, right-handed adults ages 18-50\n\nDesign:\n\nParticipants will have 3 or 4 visits at least 1 week apart. They cannot drink alcohol for at least 48 hours before each visit.\n\nThe screening visit lasts about 1 (Omega) hours. It can be combined with the first testing visit. Screening includes:\n\n* Medical history\n* Physical exam\n* Neurological exam\n* Urine tests\n* Questionnaires about being left or right handed and about their ability to imagine physical activities.\n\nThe first testing visit lasts about 1 (Omega) hours and includes an MRI. For the MRI, participants lie on a table that slides into a machine. They will lie still or perform simple memory tasks on a computer screen.\n\nThe second and third testing visits last about 3 hours. Participants will have:\n\n* 2 MRIs\n* TMS: A wire coil is held to the scalp. A brief electrical current passes through the coil to create a magnetic pulse that affects brain activity. They will perform simple memory tasks.\n* EMG: Small electrodes are taped to the skin to record muscle activity while they rest.\n\nAfter the study, participants will complete a questionnaire about any discomfort they experienced during the study.\n\n...', 'detailedDescription': 'Objective: This study aims to identify whether repetitive dual-site transcranial magnetic stimulation (TMS) can modulate the functional connectivity between the parietal and dorso-lateral prefrontal cortices.\n\nStudy population: The study involves 26 healthy volunteers.\n\nDesign: This controlled study comprises 3 main visits for each subject: (1) a baseline, evaluation visit during which fMRI will be acquired during a visual short memory task along with diffusion tensor imaging and structural MRI; (2) a visit during which resting state fMRI (rsfMRI) will be acquired, followed by paired-associative stimulation (PAS) with pulses delivered over the parietal and then over the dorso-lateral prefrontal cortex, in order to induce a temporary plastic change in the interaction between the parietal and prefrontal cortices; the PAS will be followed by another rsfMRI and task fMRI; (3) a visit identical to #2 during which the PAS will be delivered with pulses in reverse order of previous visit.\n\nOutcome measures: The effects of PAS will be quantified with rsfMRI and a short working memory task, considered as a proxy for complex motor and cognitive control.\n\n* The primary outcome will be to investigate the resting state functional connectivity changes induced by each PAS intervention\n* The secondary outcome #1 will be to evaluate the difference in visual angle error between sessions 2 and 3 in a working memory task during which the subjects will be asked to remember the position of a bar presented on the screen at different time intervals before the inquiry.\n* The secondary outcome #2 will be to build an fMRI-DTI analysis pipeline for generation of TMS targets individually customized for each subject and a given task.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n* Age between 18-50 years.\n* Right-handed (handedness questionnaire will be part of the initial evaluation)\n* Able to give informed consent.\n* Have a normal neurological exam within the last year and MoCA\\>27\n* Willing and able to abstain from alcohol for at least 48 hours prior to the study.\n* Willing to not participate in other rTMS studies in the week preceding visits for the current protocol.\n\nEXCLUSION CRITERIA:\n\n-All participants must be able to undergo MRI and TMS, for which the MRI- and TMS-safety checklists will be part of the initial evaluation, and reconfirmed at the beginning of every visit. It will constitute as exclusion criteria if the participant:\n\n* has metal in his/her body which would make having an MRI scan unsafe, such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if he/she was a welder or metal worker, since small metal fragments may be found in the eyes.\n* is uncomfortable in small closed spaces (claustrophobia) so that he/she would feel uncomfortable in the MRI machine.\n* is not able to lie comfortably on the back for up to 2 hours\n\nhas hearing loss.\n\n--is pregnant.\n\n* Self-reported consumption of \\>14 alcoholic drinks/week for a man and \\>7 alcoholic drinks/week for a woman.\n* History of or current brain tumor, stroke, head trauma with loss of consciousness, epilepsy or seizures.\n* Taking medications that act directly on the central nervous system such as anti-epileptics, anti-histamines, anti-parkinsonian medication, medication for insomnia, anti-depressants, anti-anxiety medication.'}, 'identificationModule': {'nctId': 'NCT03434093', 'briefTitle': 'Modulation of the Parieto-frontal Communication', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Modulation of the Parieto-frontal Communication', 'orgStudyIdInfo': {'id': '180054'}, 'secondaryIdInfos': [{'id': '18-N-0054'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PPC-DLPFC', 'description': 'In this arm, the TMS paired-pulses will be first delivered over the posterior parietal cortex (PPC) and then over the dorsolateral prefrontal cortex (DLPFC)', 'interventionNames': ['Device: Transcranial Magnetic Stimulation (TMS)', 'Behavioral: Working Memory Task']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DLPFC-PPC', 'description': 'Arm Description: In this arm, the TMS paired-pulses will be first delivered over the over the dorsolateral prefrontal cortex (DLPFC) and then posterior parietal cortex (PPC)', 'interventionNames': ['Device: Transcranial Magnetic Stimulation (TMS)', 'Behavioral: Working Memory Task']}], 'interventions': [{'name': 'Transcranial Magnetic Stimulation (TMS)', 'type': 'DEVICE', 'description': 'Description: This will comprise single and repeated paired-pulses delivered over motor and non-motor areas.', 'armGroupLabels': ['DLPFC-PPC', 'PPC-DLPFC']}, {'name': 'Working Memory Task', 'type': 'BEHAVIORAL', 'description': 'This will consist in remembering an item presented 1 to 5 steps before the inquiry. This task will span the whole duration of the functional MRI acquisition.', 'armGroupLabels': ['DLPFC-PPC', 'PPC-DLPFC']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mark Hallett, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Neurological Disorders and Stroke (NINDS)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}