Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT04859335
Status:
RECRUITING
Last Update Posted:
2024-08-02
First Post:
2021-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009464', 'term': 'Neuroma, Acoustic'}, {'id': 'D004244', 'term': 'Dizziness'}], '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'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2021-04-16', 'studyFirstSubmitQcDate': '2021-04-21', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI)', 'timeFrame': 'before gamma knife radiosurgery (Baseline)', 'description': 'Questionnaire including 25 items with a "yes/no/maybe" answer possibility'}, {'measure': 'quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI)', 'timeFrame': 'One year after gamma knife radiosurgery', 'description': 'Questionnaire including 25 items with a "yes/no/maybe" answer possibility'}, {'measure': 'quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI)', 'timeFrame': 'Three years after gamma knife radiosurgery', 'description': 'Questionnaire including 25 items with a "yes/no/maybe" answer possibility'}], 'secondaryOutcomes': [{'measure': 'Evolution of hearing', 'timeFrame': 'before gamma knife radiosurgery (Baseline)', 'description': 'Evaluate the evolution of hearing using data obtained during tonal audiometry (frequency by frequency between 250 Hz and 8 kHz, average hearing loss calculated on the frequencies 0.5, 1, 2, and 4 kHz)'}, {'measure': 'Evolution of hearing', 'timeFrame': 'One year after gamma knife radiosurgery', 'description': 'Evaluate the evolution of hearing using data obtained during tonal audiometry (frequency by frequency between 250 Hz and 8 kHz, average hearing loss calculated on the frequencies 0.5, 1, 2, and 4 kHz)'}, {'measure': 'Evolution of hearing', 'timeFrame': 'Three years after gamma knife radiosurgery', 'description': 'Evaluate the evolution of hearing using data obtained during tonal audiometry (frequency by frequency between 250 Hz and 8 kHz, average hearing loss calculated on the frequencies 0.5, 1, 2, and 4 kHz)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vestibular Schwannoma', 'Gammaknife radiosurgery', 'Dizziness', 'Balance'], 'conditions': ['Vestibular Schwannoma']}, 'descriptionModule': {'briefSummary': 'Vestibular schwannomas are benign lesions of the ponto-cerebellar angle that are potentially dangerous because of their growth in a cramped space and the compressive phenomena they can cause. Stereotactic Gammaknife radiosurgery is a treatment option that can be offered for evolutive schwannomas smaller than 2.5-3 cm in size. It allows tumor stabilisation in 85% of cases with less than 1% facial nerve damage risk.\n\nThere are controversial results regarding hearing preservation : percentages vary between 25 and 80% in the literature, depending on the criteria used and the post-treatment delay.\n\nFew studies have investigated changes in vestibular function and the impact on balance of radiosurgery, and their results are variable.\n\nThese controversial results lead us to comprehensively assess the vestibular function and balance of these patients using a balance-specific quality of life questionnaire, in addition to objective overall vestibular assessments of vestibular function.', 'detailedDescription': 'Vestibular schwannomas are benign lesions of the ponto-cerebellar angle that are potentially dangerous because of their growth in a cramped space and the compressive phenomena they can cause. Stereotactic Gammaknife radiosurgery is a treatment option that can be offered for evolutive schwannomas smaller than 2.5-3 cm in size. It allows tumor stabilisation in 85% of cases with less than 1% facial nerve damage risk.\n\nThere are controversial results regarding hearing preservation : percentages vary between 25 and 80% in the literature, depending on the criteria used and the post-treatment delay.\n\nFew studies have investigated changes in vestibular function and the impact on balance of radiosurgery.Their results are heterogeneous, on one hand, indicating little worsening of symptoms, or even improvement in some studies. On the other hand, a 2017 study reported symptomatic worsening of caloric response deficits in 17.6% of cases. Vestibular function at high frequencies or for otolithic organs (utricle and saccule) has hardly ever been explored.\n\nThe largest cohort, reported in "gammaknife radiosurgery for vestibular schwannomas a quality of life evaluation" concerns 353 patients and shows that the overall quality of life of the patients treated is on average comparable to that of the general population but that the vertigo is more frequent in this population, with a more marked impact on the overall quality of life.\n\nThese controversial results lead us to comprehensively assess the vestibular function and balance of these patients using a balance-specific quality of life questionnaire, in addition to objective overall vestibular assessments of vestibular function.\n\nThus, the present study aims to assess the quality of balance of patients treated with Gammaknife radiosurgery for vestibular schwannoma at 1 year and 3 years after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Vestibular schwannoma's Patients for whom an indication of gammaknife radiosurgery was determined in a dedicated multidisciplinary consultation meeting, having not received previous treatment for this schwannoma.\n* Patient affiliated to Social Security\n* No opposition to participation\n\nExclusion Criteria:\n\n* History of prior treatment for the presented vestibular schwannoma (surgery, fractional radiotherapy)\n* History of otological or otoneurological pathology associated with schwannoma\n* Patient with type 2 neurofibromatosis\n* Patient under legal protection\n* Pregnant or breastfeeding women"}, 'identificationModule': {'nctId': 'NCT04859335', 'acronym': 'EQUI-GAMMA', 'briefTitle': 'Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Prospective Study : Long-term Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma EQUI-GAMMA', 'orgStudyIdInfo': {'id': 'RC31/21/0034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Schwannomas patients needing gammaknife radiosurgery', 'description': 'Patients will undergo balance and hearing questionnaires before and after gammaknife radiosurgery.\n\nThis is a before/after analysis needing only one arm: the "before" data will serve as control to the "after" data', 'interventionNames': ['Radiation: gammaknife radiosurgery']}], 'interventions': [{'name': 'gammaknife radiosurgery', 'type': 'RADIATION', 'description': 'Patients will undergo questionnaires before the gammaknife radiosurgery, then one year and three years after the intervention.', 'armGroupLabels': ['Schwannomas patients needing gammaknife radiosurgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathieu MARX', 'role': 'CONTACT'}], 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Mathieu MARX, MD Phd', 'role': 'CONTACT', 'email': 'marx.m@chu-toulouse.fr', 'phone': '(+33)5 61 77 77 04'}], 'overallOfficials': [{'name': 'Mathieu MARX, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}