Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-29 @ 9:46 AM
Study NCT ID:
NCT07130851
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-19
First Post:
2025-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mapping of Vestibular Centers Activation Using fMRI in Patients With Vestibular Schwannoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009464', 'term': 'Neuroma, Acoustic'}], 'ancestors': [{'id': 'D009442', 'term': 'Neurilemmoma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009463', 'term': 'Neuroma'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D003390', 'term': 'Cranial Nerve Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010524', 'term': 'Peripheral Nervous System Neoplasms'}, {'id': 'D000160', 'term': 'Vestibulocochlear Nerve Diseases'}, {'id': 'D012181', 'term': 'Retrocochlear Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2025-07-05', 'studyFirstSubmitQcDate': '2025-08-18', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of cortical vestibular center in acute unilateral vestibular lesion', 'timeFrame': 'baseline and one week', 'description': 'Fuctional magnetic resonance (fMRI) could display certain areas of the brain and its pathways involved in the process of central compensation resulting from the acute unilateral vestibular lesion.\n\nWe aim to compare pre- and post- operative fMRI results with the results of healthy controls to see whether there is a difference in activating vestibular centers and maintaining the equilibrium after the central compensation occurs. Different level of activation of vestibular cortical areas, resp. differences in activation in response to optokinetic stimulation will be measured in healthy controls and study group. Evaluation of functional brain MRI will be provided by expert neuroradiologist. Vestibular function will be assessed by objective vestibular tests (videonystagmography, video Head Impuls Test) and by subjective scales (questionnaires - The Penn Acoustic Neuroma Quality-of-Life scale, Dizziness Handicap Inventory - in both the higher score indicates higher handicap).'}], 'secondaryOutcomes': [{'measure': 'Change in cortical activation in response to acute onset of vestibular loss', 'timeFrame': 'baseline and one week', 'description': 'Evaluation of differences between control and study group in functional brain MRI in response to wide field optokinetic stimulation. Differences in size and level of activation of vestibular cortical areas will be evaluated by expert neuroradiologist.'}, {'measure': 'Possible influence of vestibular training in virtual reality environment on the rate of vestibular center activation', 'timeFrame': 'baseline and 3 months', 'description': 'The cohort group, which undergoes vestibular rehabilitation in virtual reality environment, will be evaluated and compared to control and study group. Functional brain MRI in response to wide field optokinetic stimulation will be evaluated by expert neuroradiologist.\n\nThe obtained data could serve as a basis for understanding the possibility of influencing the central compensation process and potentially, in the future, utilizing virtual reality as a tool for vestibular training.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vestibular centers', 'functional magnetic resonance', 'vestibular schwannoma', 'central compensation'], 'conditions': ['Vestibular Schwannoma', 'Unilateral Vestibular Deficit', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '19645932', 'type': 'BACKGROUND', 'citation': 'Hufner K, Stephan T, Hamilton DA, Kalla R, Glasauer S, Strupp M, Brandt T. Gray-matter atrophy after chronic complete unilateral vestibular deafferentation. Ann N Y Acad Sci. 2009 May;1164:383-5. doi: 10.1111/j.1749-6632.2008.03719.x.'}, {'pmid': '20802221', 'type': 'BACKGROUND', 'citation': 'Helmchen C, Klinkenstein JC, Kruger A, Gliemroth J, Mohr C, Sander T. Structural brain changes following peripheral vestibulo-cochlear lesion may indicate multisensory compensation. J Neurol Neurosurg Psychiatry. 2011 Mar;82(3):309-16. doi: 10.1136/jnnp.2010.204925. Epub 2010 Aug 27.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to visualize the possible activation of vestibular centers in the brain using in patiens with unilateral vestibular damage, specifically in patients after vestibular schwannoma surgery.\n\nThe main questions it aims to answer are:\n\n1. Is there a difference in the proces sof activation of vestibular centers in patients with unilateral vestibular disorder and healthy subjects.\n2. Are we able to effect this activation with our postoperative treatment? Researchers will compare the obtained results between patients with unilateral vestibular disorder and healthy controls.\n\nParticipants will be asked to fill out the set of questionaires, to undergo clinical objective vestibular examnation and examination in magnetic resonance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* vestibular schwannoma\n\nExclusion Criteria:\n\n* claustrophobia, visual impairment'}, 'identificationModule': {'nctId': 'NCT07130851', 'briefTitle': 'Mapping of Vestibular Centers Activation Using fMRI in Patients With Vestibular Schwannoma', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Mapping of Vestibular Center Activation Using fMRI in Patients With Vestibular Schwannoma', 'orgStudyIdInfo': {'id': 'EK-279.4/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vetibular schwannoma patients', 'description': 'Patients with vestibular schwannoma undergoing surgical removal of the tumor one day before the surgery: objective methods videoHead Impulse test, cervical vestibular evoked myogenic potentials, air calorics, clinical otoneurologic examination, functional magnetic resonance subjective methods: questionnaires (DHI,..) one week after the surgery: objective methods videoHead Impulse test, clinical otoneurologic examination, functional magnetic resonance subjective methods: questionnaires (DHI,..)', 'interventionNames': ['Procedure: vestibular schwannoma resection']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy controls', 'description': 'The healty patients without the history of vestibular disorder. objective methods videoHead Impulse test, cervical vestibular evoked myogenic potentials, functional magnetic resonance subjective methods: questionnaires (DHI,..)'}], 'interventions': [{'name': 'vestibular schwannoma resection', 'type': 'PROCEDURE', 'description': 'Vestibular schwannoma resection leads to partial or combined acute unilateral peripheral or combined vestibular lesion.The organism responds with the process of central vestibular compensation.', 'armGroupLabels': ['Vetibular schwannoma patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150 06', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Department of Otorhinolaryngology and Head and Neck Surgery, 1st Medical Faculty Charles University and University Hospital Motol', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'IPD used in the results publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marketa Bonaventurova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Marketa Bonaventurova', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}