Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:22 AM
Study NCT ID:
NCT07455461
Status:
RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cortical Excitability During de Novo Motor Learning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Motor Evoked Potential (MEP) Amplitude Input-Output Curve Assessed by Single-Pulse TMS', 'timeFrame': 'Baseline (Day 1, pre-session), immediately post-session on Day 1, pre-session on Day 2, immediately post-session on Day 2, pre-session on Day 9, and immediately post-session on Day 9', 'description': 'Motor Evoked Potential amplitude (mV) recorded from the target muscle (Abductor Pollicis Brevis) in response to increasing TMS intensities. The parameters of the sigmoid input-output curve will be calculated using a Boltzmann function fit.'}, {'measure': 'Change in Short-Interval Intracortical Inhibition (SICI) Assessed by Paired-Pulse TMS', 'timeFrame': 'Baseline (Day 1, pre-session), immediately post-session on Day 1, pre-session on Day 2, immediately post-session on Day 2, pre-session on Day 9, and immediately post-session on Day 9', 'description': 'Conditioned MEP amplitude expressed as a ratio of unconditioned MEP amplitude (%), using a conditioning stimulus at 80% RMT and inter-stimulus interval of 3 ms.'}, {'measure': 'Change in Long-Interval Intracortical Inhibition (LICI) Assessed by Paired-Pulse TMS', 'timeFrame': 'Baseline (Day 1, pre-session), immediately post-session on Day 1, pre-session on Day 2, immediately post-session on Day 2, pre-session on Day 9, and immediately post-session on Day 9', 'description': 'Conditioned MEP amplitude as a ratio of unconditioned MEP amplitude (%), using a conditioning stimulus at suprathreshold intensity and inter-stimulus interval of 100ms.'}, {'measure': 'Change in Intracortical Facilitation (ICF) Assessed by Paired-Pulse TMS', 'timeFrame': 'Baseline (Day 1, pre-session), immediately post-session on Day 1, pre-session on Day 2, immediately post-session on Day 2, pre-session on Day 9, and immediately post-session on Day 9', 'description': 'Conditioned MEP amplitude as a ratio of unconditioned MEP amplitude (%), using a conditioning stimulus at 80% RMT and an inter-stimulus interval of 10ms.'}], 'secondaryOutcomes': [{'measure': 'Change in Motor Learning Performance Assessed by Movement Path Length During a 3D Finger-Cursor Task', 'timeFrame': 'During each motor learning session on Day 1, Day 2, and Day 9', 'description': 'Path length (mm) of the cursor trajectory during each trial of the motor learning task. Shorter path length indicates more efficient, learned movement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Motor Learning', 'Corticospinal Excitability']}, 'descriptionModule': {'briefSummary': "De novo motor learning is a specific learning paradigm that allows investigation of how a new motor skill is learned from scratch. Motor task learning can induce increased corticospinal excitability and reorganization of connectivity observed within the motor cortex (M1). Several studies have investigated the plasticity mechanisms underlying motor learning using simple paradigms. The results obtained have been variable, with a major trend toward increased corticospinal excitability, while other results show no increase. We expect to observe a significant increase in excitability and enhanced intracortical reorganization mechanisms within M1 in our subjects during our de novo motor learning sessions.\n\nThe primary objective of this study is to measure changes in corticospinal excitability of the motor system across 3 de novo motor learning sessions separated by different time intervals.\n\nThe secondary objectives will be: 1) to measure learning across the three practice sessions, 2) to measure changes in inhibition and facilitation across the 3 learning sessions, and 3) to measure correlations between subjects' motor performance and corticospinal and intracortical changes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* right-handed\n* healthy\n* having signed an informed consent form\n\nExclusion Criteria:\n\n* counter-indication to transcranial magnetic stimulation\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT07455461', 'acronym': 'StimNovoLearn', 'briefTitle': 'Cortical Excitability During de Novo Motor Learning', 'organization': {'class': 'OTHER', 'fullName': "Universite du Littoral Cote d'Opale"}, 'officialTitle': 'Cortical Excitability During de Novo Motor Learning in Healthy Subjects : an Exploratory Longitudinal Study', 'orgStudyIdInfo': {'id': '2023-A02139-36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motor learning', 'description': 'Subjects follow a de novo motor learning protocol', 'interventionNames': ['Behavioral: De novo motor learning']}], 'interventions': [{'name': 'De novo motor learning', 'type': 'BEHAVIORAL', 'description': 'Subjects will follow 3 sessions of de-novo motor learning (days 1, 2, 8)', 'armGroupLabels': ['Motor learning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59120', 'city': 'Loos', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre D Morel, Doctor', 'role': 'CONTACT', 'email': 'pierre.morel@univ-littoral.fr', 'phone': '0033781692692'}], 'facility': 'Eurasport', 'geoPoint': {'lat': 50.60982, 'lon': 3.01874}}], 'centralContacts': [{'name': 'Pierre D Morel, Dr', 'role': 'CONTACT', 'email': 'pierre.morel@univ-littoral.fr', 'phone': '0033781692692'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Universite du Littoral Cote d'Opale", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}