Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:44 PM
Study NCT ID:
NCT03537469
Status:
COMPLETED
Last Update Posted:
2018-05-29
First Post:
2018-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neuromodulation With Low Frequency-Pulsed Electromagnetic Fields
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The subjects and operators who performed TMS were blinded to the type of stimulation applied, we then employed a randomized double-blind sham-controlled crossover design.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-24', 'studyFirstSubmitDate': '2018-04-29', 'studyFirstSubmitQcDate': '2018-05-15', 'lastUpdatePostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cortical Excitability change across time', 'timeFrame': 'Baseline and after 15, and 30 minutes', 'description': 'Motor evoked potential (MEP) amplitude registered by TMS after sham or real stimulation at different time points, evaluating the differences among timepoints.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Electromagnetic Fields', 'Neuronal Plasticity', 'Transcranial Magnetic Stimulation']}, 'referencesModule': {'references': [{'pmid': '29895259', 'type': 'DERIVED', 'citation': 'Premi E, Benussi A, La Gatta A, Visconti S, Costa A, Gilberti N, Cantoni V, Padovani A, Borroni B, Magoni M. Modulation of long-term potentiation-like cortical plasticity in the healthy brain with low frequency-pulsed electromagnetic fields. BMC Neurosci. 2018 Jun 13;19(1):34. doi: 10.1186/s12868-018-0434-z.'}]}, 'descriptionModule': {'briefSummary': 'Non-depolarizing magnetic fields, like Low Frequency-Pulsed Electromagnetic Fields (LF-PEMFs) have shown the ability to modulate living structures, principally by influencing synaptic activity and ion channels on cellular membranes. Recently, the CTU Mega 20 device was presented as a molecular accelerator, using energy up to 200 Joules and providing high-power (2 Tesla) pulsating fields with a water-repulsive (diamagnetic) action and tissue biostimulation. The investigators tested the hypothesis that LF-PEMFs could modulate long-term corticospinal excitability in healthy brains by applying CTU Mega 20®. Ten healthy subjects without known neurological and/or psychiatric diseases entered the study. A randomized double-blind sham-controlled crossover design was employed, recording TMS parameters (amplitude variation of the motor evoked potential as index of cortical excitability perturbations of the motor system) before (pre) and after (post +0, +15, +30 min) a single CTU Mega 20 session on the corresponding primary right-hand motor area, using a real (magnetic field = 2 Tesla; intensity = 90 J; impulse frequency = 7Hz; duration = 15 minutes) or sham device. A two-way repeated measures ANOVA with TIME (pre, post +0, +15, +30 min) and TREATMENT (real vs sham stimulation) as within-subjects factor was applied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects between 18 and 35 years\n\nExclusion Criteria:\n\n* Known neurological or psychiatric diseases'}, 'identificationModule': {'nctId': 'NCT03537469', 'briefTitle': 'Neuromodulation With Low Frequency-Pulsed Electromagnetic Fields', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia'}, 'officialTitle': 'Modulation of Long-Term Potentiation-Like Cortical Plasticity in the Healthy Brain With Low Frequency-Pulsed Electromagnetic Fields', 'orgStudyIdInfo': {'id': 'NP-2322'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CTU Mega 20 real device', 'description': 'A single-session of real CTU Mega 20 on the corresponding primary right-hand motor area, using the real (magnetic field = 2 Tesla; intensity = 90 J; frequency of impulses = 7Hz; duration = 15 minutes) CTU Mega 20 device. This real stimulation provided a Low Frequency-Pulsed Electromagnetic Fields (LF-PEMFs).', 'interventionNames': ['Device: CTU Mega 20 real device']}, {'type': 'SHAM_COMPARATOR', 'label': 'CTU Mega 20 sham device', 'description': 'A single-session of sham CTU Mega 20 on the corresponding primary right-hand motor area (magnetic field = 0 Tesla; intensity = 0 J; frequency of impulses = 7Hz; duration = 15 minutes). The sham stimulation did not provide a Low Frequency-Pulsed Electromagnetic Fields (LF-PEMFs).', 'interventionNames': ['Device: CTU Mega 20 sham device']}], 'interventions': [{'name': 'CTU Mega 20 real device', 'type': 'DEVICE', 'description': 'The CTU Mega 20 diamagnetic acceleration system discharges high-field magnetic impulses (with a duration of 5 ms and a period of 1000 ms), generating a magnetic field up to 2 Tesla, with a frequency of 7500 Hz in a volume of approximately 27 cm3.', 'armGroupLabels': ['CTU Mega 20 real device']}, {'name': 'CTU Mega 20 sham device', 'type': 'DEVICE', 'description': 'A CTU Mega 20 sham device (with an identical appearance to that of the real device) to avoid treatment identification by the patient or experimenter was used. Of course, the application of this sham device did not provide any magnetic field.', 'armGroupLabels': ['CTU Mega 20 sham device']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mauro Magoni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'U.O. Neurologia Vascolare, Azienda Ospedaliera Spedali Civili, Brescia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of U.O. Neurologia Vascolare', 'investigatorFullName': 'MAURO MAGONI', 'investigatorAffiliation': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia'}}}}