Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-28 @ 12:57 PM
Study NCT ID:
NCT06401057
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Register for Longitudinal Recording of Brain Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-01', 'studyFirstSubmitDate': '2024-01-07', 'studyFirstSubmitQcDate': '2024-05-01', 'lastUpdatePostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive status', 'timeFrame': 'until last patient FU up to 48 months', 'description': 'Higher cognitive functions - determined by the Montreal Cognitive Assessment (MocA)'}, {'measure': 'Language status', 'timeFrame': 'until last patient FU up to 48 months', 'description': 'Language function tested by the Aphasia Check List'}, {'measure': 'Motor status', 'timeFrame': 'until last patient FU up to 48 months', 'description': 'Motor function according to the BMRC scale'}, {'measure': 'cortical data', 'timeFrame': 'until last patient FU up to 48 months', 'description': 'cortical nTMS-Data - distribution according the cortical parellation system'}, {'measure': 'Fiber tracts', 'timeFrame': 'until last patient FU up to 48 months', 'description': 'Volume of fiber tracts'}, {'measure': 'Fiber tracts', 'timeFrame': 'until last patient FU up to 48 months', 'description': 'fractional anisotropy of fiber tracts'}, {'measure': 'structural imaging (Connectome)', 'timeFrame': 'until last patient FU up to 48 months', 'description': 'characteristics of Connectome and Disconnectome analysis (Global Efficiency value)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patients With Brain Masses/Lesions']}, 'referencesModule': {'references': [{'pmid': '41359250', 'type': 'DERIVED', 'citation': 'Schwendner M, Kram L, Zhang H, Krieg SM, Ille S. Preoperative nTMS-based mapping of a verbal semantic association task allows for the identification of extensive bihemispheric cortical and subcortical networks. J Neurooncol. 2025 Dec 8;176(1):108. doi: 10.1007/s11060-025-05355-9.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this observational register study is to establish a registry that completely records and compiles the data from routinely performed technical examinations (navigated transcranial magnetic stimulation, intraoperative neuromonitoring and stimulation, MRI imaging including tractography and connectome) and clinical tests over time (pre-, intra- and postoperative, under adjuvant therapy, as part of follow-up care) of patients with intracranial masses and lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with brain masses/lesions (especially tumors (cerebral and non-cerebral, inflammation (infectious and non-infectious), vascular pathologies)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intracranial lesion\n* Age ≥ 18 years\n* Written consent to participate in the study\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Patients not able to give consent\n* Patients with intracranial ferromagnetic metal implants\n* Patients with implanted electronic devices'}, 'identificationModule': {'nctId': 'NCT06401057', 'briefTitle': 'Register for Longitudinal Recording of Brain Function', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Heidelberg'}, 'officialTitle': 'Register for Longitudinal Recording of Brain Function in Patients With Brain Diseases', 'orgStudyIdInfo': {'id': 'Fun-Reg'}}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Maximilan Schwendner, MD', 'role': 'CONTACT', 'email': 'maximilian.schwendner@med.uni-heidelberg.de', 'phone': '+49 6221 56 6999'}, {'name': 'Sebastian Ille, MD', 'role': 'CONTACT'}], 'facility': 'Department of Neurosurgery Heidelberg University Hospital', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'For selected subgroups, data sharing is possible depending on data safety regulations'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Schwendner Maximilian', 'investigatorAffiliation': 'University Hospital Heidelberg'}}}}