Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 6:59 AM
Study NCT ID:
NCT07335692
Status:
RECRUITING
Last Update Posted:
2026-01-13
First Post:
2026-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamical Electrophysiology and Neuropathology in Lewy's Bodies Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020961', 'term': 'Lewy Body Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-06-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-02', 'studyFirstSubmitDate': '2026-01-02', 'studyFirstSubmitQcDate': '2026-01-02', 'lastUpdatePostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parameter θ of dynamic fluidity of brain activity', 'timeFrame': 'Up to 12 months', 'description': "Parameter θ of dynamic fluidity of brain activity (quantifying the system's ability to move away from its current configuration)\n\nθ is used to measure something specific in the brain: how flexible its activity is.\n\nQuantifying the system's ability to move away from its current configuration:\n\n* In plain words, θ tells us how much the brain can change from its current state.\n* High θ → brain is very flexible, can switch between states easily.\n* Low θ → brain is rigid, stays in the same pattern longer."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lewy Body Disease', 'Neurodegenerative disorder'], 'conditions': ['Lewy Body Disease']}, 'descriptionModule': {'briefSummary': 'Lewy body disease (LBD) is a neurodegenerative disorder that causes cognitive and behavioral problems. However, it is difficult to diagnose, and its pathophysiology is still not fully understood. The usual diagnostic criteria for LBD have excellent specificity but poor sensitivity. In particular, we lack paraclinical tests that can make a significant contribution. LBD patients may exhibit abnormalities in brain activity dynamics, which can be detected by EEG and may be linked to neuronal dysfunctions specific to the disease. The objective of this study is twofold: first, to assess the validity of this observation, that is, to confirm that the observed phenomenon is indeed linked to the pathophysiology of LBD, and second, to clarify the nature of these abnormalities by exploring the brain dynamics of LBD patients in greater detail.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult subjects (≥18 years old) who participated in the Alpha-Lewy-MA cohort and underwent RT-QuIC analysis and underwent a standard EEG examination at HUS between January 1, 2012, and January 1, 2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult subjects (≥18 years old).\n* Subject who participated in the Alpha-Lewy-MA cohort and underwent RT-QuIC analysis.\n* Subject who underwent a standard EEG examination at HUS between January 1, 2012, and January 1, 2020.\n\nExclusion Criteria:\n\n\\- Subject who expressed opposition to participating in the study.'}, 'identificationModule': {'nctId': 'NCT07335692', 'acronym': 'DYNAPATH-LB', 'briefTitle': "Dynamical Electrophysiology and Neuropathology in Lewy's Bodies Disease", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': "Dynamical Electrophysiology and Neuropathology in Lewy's Bodies Disease", 'orgStudyIdInfo': {'id': '9691'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ludovic DORMEGNY-JEANJEAN, MD', 'role': 'CONTACT', 'email': 'ludovic.jeanjean@chru-strasbourg.fr', 'phone': '33 3 88 11 69 21'}, {'name': 'Ludovic DORMEGNY-JEANJEAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de psychiatrie de la personne âgée - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Ludovic DORMEGNY-JEANJEAN, MD', 'role': 'CONTACT', 'email': 'ludovic.jeanjean@chru-strasbourg.fr', 'phone': '33 3 88 11 69 21'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}