[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vestibular-schwannoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vestibular-schwannoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,50,80,106,133,161,192,218,242,262,282,314,339],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100391232","phase-2-innovative-trial-for-understanding-the-impact-of-targeted-therapies-in-nf2-related-schwannomatosis-intuitt-nf2-100391232",false,"NCT04374305","Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)","INTUITT-NF2","Eligibility Specific For MASTER PROTOCOL:\n\nInclusion Criteria:\n\n\\- Patients must have a pathogenic variant in the NF2 gene (either in the germline or in two NF2-related tumors) OR a confirmed diagnosis of NF2 by fulfilling National Institute of Health (NIH) criteria or Manchester criteria:\n\nThe NIH criteria includes presence of:\n\n* Bilateral vestibular schwannomas, OR\n* First-degree relative with NF2 and EITHER unilateral eighth nerve mass OR two of the following: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity.\n\nThe Manchester criteria includes presence of:\n\n* Bilateral vestibular schwannomas, OR\n* First-degree relative with NF2 and EITHER unilateral eighth nerve mass OR two of the following: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity, OR\n* Unilateral vestibular schwannoma AND any two of: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity, OR\n* Multiple meningiomas (two or more) AND unilateral vestibular schwannoma OR any two of: schwannoma, glioma, neurofibroma, cataract.\n\nSubjects must have a target NF2-related tumor (VS, non-VS, meningioma, or ependymoma) with documented radiographic progression within the preceding 36 months of Master Study registration defined as either:\n\n* at least 20% increase in volume of enhancing tumor\n* at least 2 mm increase in greatest linear dimension of enhancing tumor\n\nParticipants must have measurable disease, defined as:\n\n* VS, non-VS, or meningioma target lesions that can be accurately measured as at least 1 ml by volumetric MRI scan or in at least one dimension as ≥10 mm with conventional MRI scan. See protocol for the evaluation of measurable disease\n* Ependymoma target lesions measurable linearly.\n\nParticipant must have a target NF2-related tumor with the following qualities:\n\n* Not amenable to surgery due to patient refusal or due to high risk for surgical complications (e.g., damage to nerve function). Participant must be ≥ 12 years of age on Day 1 of treatment. Life expectancy of greater than 1 year Karnofsky performance status ≥ 70 or ECOG PS 0 or 1 (see Appendix A). Ability to understand and the willingness to sign written informed consent and assent documents.\n* Must have established relationship with primary care physician and provide contact information\n\nExclusion Criteria:\n\n* Participants who have had chemotherapy within a minimum of 4 weeks prior to Master Study registration (or a minimum of 5 half-lives and resolution to baseline of toxicities unless there are irreversible toxicities from prior drug that do not influence risk of next drug).\n* Participants who have received radiation to the target tumor within the last 3 years prior to Master study registration.\n* Participants who are receiving any other investigational agents.\n* Participants with target or non-target nervous system tumors that, in the opinion of the treating investigator, are likely to require active treatment (including surgery) within 6 months of registration to the Master Study.\n* History of a different malignancy, unless (a) have been disease-free for at least 2 years and are deemed by the treating investigator to be at low risk for recurrence of that malignancy.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because the experimental agents may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these experimental agents, breastfeeding should be discontinued if the mother is treated.\n\nEligibility Criteria Specific to SUB-STUDY A (Brigatinib arm): CLOSED TO ENROLLMENT\n\nInclusion criteria\n\n* Participants must meet all eligibility criteria outlined in the Master Study\n* Participants must be willing and able to provide written informed consent\u002Fassent for the brigatinib arm of the INTUITT-NF2 trial.\n* Participant is ≥ 12 years of age and has body weight at least 40 kg on Day 1 of treatment.\n* Patient must be able to swallow pills.\n* Clinical laboratory values as specified below within 28 days before the first dose of study drug, as described in the protocol document:\n* Female patients participating in this study should avoid becoming pregnant, and male patients should avoid impregnating a female partner. Non-sterilized female patients of reproductive age group and male patients should use effective methods of contraception through defined periods during and after study treatment as specified below:\n\nFemale patients must meet 1 of the following:\n\n* Postmenopausal for at least 1 year before the screening visit, or\n* Surgically sterile, or\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing of the informed consent form through 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse. Brigatinib may decrease effectiveness of hormonal contraceptives, therefore, women are recommended to use non-hormonal methods of contraception. Highly effective non-hormonal birth control for women of child bearing potential with male partners includes:\n\n  * Sexual abstinence (no sexual intercourse)\n  * Intrauterine device (IUD) or intrauterine system (IUS)\n  * Bilateral tubal ligation (both tubes tied)\n  * Vasectomized partner\n\nMale patients, even if surgically sterilized (i.e., status post-vasectomy) must agree to 1 of the following:\n\n\\- Practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or completely abstain from heterosexual intercourse.\n\nExclusion criteria:\n\n* Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug (if applicable)\n* Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol\n* Treatment with any investigational products within 1 month or 5 half-lives (whichever is longer) before the first dose of study drug\n* Had major surgery within 30 days of the first dose of brigatinib. Minor surgical procedures such as catheter placement or minimally invasive biopsies are allowed.\n* Have significant, uncontrolled, or active cardiovascular disease (as outlined in the protocol):\n* Have uncontrolled hypertension (defined as an average systolic blood pressure \\>160 or an average diastolic blood pressure \\>100 for adults; for children: please refer to table in protocol\n\nEligibility Criteria Specific to SUB-STUDY B (Neratinib arm):\n\n* Participants must be willing and able to provide written informed consent\u002Fassent for the neratinib arm of the INTUITT-NF2 trial.\n* Participant must be ≥ 12 years of age and have body weight ≥ 40 kg on Day 1 of treatment.\n* Patient must be able to swallow pills.\n* Recovery (ie, to Grade 1 or baseline) from all clinically significant AEs related to prior therapies (excluding alopecia, neuropathy, and nail changes).\n* Clinical laboratory values as specified below within 14 days before the first dose of study drug:\n* ALT\u002Faspartate aminotransferase (AST) ≤ 2.5 × institutional upper limit of normal (ULN);\n* Total serum bilirubin ≤ 1.5 × institutional ULN (\\\u003C3.0 × institutional ULN for patients with Gilbert syndrome)\n* Estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73 m2, using the modification of diet in renal disease (MDRD) equation\n* Serum lipase ≤1.5 × institutional ULN\n* Absolute neutrophil count ≥1.5 × 109\u002FL\n* Platelet count ≥75 × 109\u002FL\n* Hemoglobin ≥9 g\u002FdL\n* Left ventricular ejection fraction (LVEF) ≥50% measured by multiple-gated acquisition scan (MUGA) or echocardiogram (ECHO).\n* It is not known what effects neratinib has on human pregnancy or development of the embryo or fetus. Therefore, female patients participating in this study should avoid becoming pregnant, and male patients should avoid impregnating a female partner. Non-sterilized female patients of reproductive age group and male patients should use effective methods of contraception through defined periods during and after study treatment as specified below:\n\nFemale patients must meet 1 of the following:\n\n* Postmenopausal for at least 1 year before the screening visit, or\n* Surgically sterile, or\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing of the informed consent form through 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse. Neratinib may decrease effectiveness of hormonal contraceptives, therefore, women are recommended to use non-hormonal methods of contraception. Highly effective non-hormonal birth control for women of child bearing potential with male partners includes:\n\n  * Sexual abstinence (no sexual intercourse)\n  * Intrauterine device (IUD) or intrauterine system (IUS)\n  * Bilateral tubal ligation (both tubes tied)\n  * Vasectomized partner\n\nMale patients, even if surgically sterilized (i.e., status post-vasectomy) must agree to 1 of the following:\n\n* Practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or completely abstain from heterosexual intercourse.\n* Female patients must have negative β-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause. \\[Women are considered postmenopausal if they are ≥12 months without menses, in the absence of endocrine or anti-endocrine therapies.\\]\n\nExclusion Criteria\n\n* Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug (if applicable)\n* Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol\n* Treatment with any investigational products within 28 days or 5 half-lives (whichever is longer) before the first dose of study drug\n* Had major surgery within 30 days of the first dose of neratinib. Minor surgical procedures such as catheter placement or minimally invasive biopsies are allowed.\n* Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:\n* Myocardial infarction within 6 months before the first dose of neratinib.\n* Unstable angina within 6 months before first dose of neratinib.\n* Congestive heart failure within 6 months before first dose of neratinib.\n* History of clinically significant atrial arrhythmia (including clinically significant bradyarrhythmia), as determined by the treating physician.\n* Any history of clinically significant ventricular arrhythmia.\n* Had a cerebrovascular accident or transient ischemic attack within 6 months before first dose of neratinib.\n* QTc interval \\>0.450 seconds (males) or \\>0.470 (females), or known history of QTc prolongation or Torsade de Pointes (TdP)\n* Have a known history of HIV infection. Testing is not required in the absence of history.\n* Have malabsorption syndrome or other GI illness that could affect oral absorption of neratinib. Note: This includes any predisposing chronic condition resulting in baseline grade 2 or higher diarrhea\n* History of severe allergic reactions or intolerability attributed to compounds of similar chemical or biologic composition to neratinib.\n* Have any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of neratinib.\n* Concurrent use of enzyme-inducing antiepileptic drugs (EIAEDs), including phenytoin, carbamazepine, oxcarbazepine, fosphenytoin, phenobarbital, pentobarbital, or primidone\n* Received systemic treatment with certain cytochrome P-450 inhibitors or inducers within 14 days before enrollment.\n\nEnrollment Criteria Specific to SUB-STUDY C (retifanlimab plus bevacizumab arm):\n\nInclusion Criteria\n\n* Participants must be willing and able to provide written informed consent\u002Fassent for the retifanlimab-bevacizumab arm of the INTUITT-NF2 trial.\n* Participants must have a target NF2-related tumor (VS, non-VS, meningioma, or ependymoma) with documented radiographic progression within the preceding 36-months.\n* Age between 12 and 25 years on day 1 of treatment.\n* Life expectancy of greater than 1 year.\n* Participants must meet the following organ and marrow function as defined below:\n\n  1. Leukocytes ≥3000\u002FmcL\n  2. Platelets ≥100,000\u002FmcL\n  3. Total Bilirubin ≤ 1.5 institutional upper limit of normal (ULN), (\\\u003C3.0 × institutional ULN for patients with Gilbert Syndrome)\n  4. AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional ULN\n  5. Urine Protein:Creatinine Ratio ≤ 1.9\n  6. Glomerular Filtration Rate (GFR) ≥30 mL\u002Fmin\u002F1.73 m2\n* Inhibition of the PD-1\u002FPD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Therefore, female patients participating in this study should avoid becoming pregnant, and male patients should avoid impregnating a female partner. Non-sterilized female patients of reproductive age group and male patients should use effective methods of contraception through defined periods during and after study treatment as specified below:\n\nFemale patients must meet 1 of the following:\n\n* Postmenopausal, defined as ≥12 consecutive months of amenorrhea in the absence of endocrine or anti-endocrine therapy, for a minimum of 1 year prior to screening visit, or\n* Surgically sterile, or\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing of the informed consent form through 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse. Highly effective non-hormonal birth control for women of childbearing potential with male partners may include:\n* Sexual abstinence (no sexual intercourse)\n* Intrauterine device (IUD) or intrauterine system (IUS)\n* Bilateral tubal ligation (both tubes tied)\n* Vasectomized partner Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to 1 of the following:\n* Practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or\n* Completely abstain from heterosexual intercourse.\n\nExclusion Criteria\n\n* History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to retifanlimab or bevacizumab\n* Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period prior to registration.\n* Treatment with any investigational products or chemotherapy within 28 days or 5 half-lives (whichever is longer) before the first dose of study drug.\n* Treatment with bevacizumab or any PD-1\u002FPD-L1 inhibitor within 180 days before the first dose of study drug.\n* Had major surgery within 30 days of the first dose of study drug. Minor surgical procedures such as catheter placement or minimally invasive biopsies are allowed.\n* Serious or non-healing wound, ulcer, or bone fracture.\n* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to Day 1.\n* Imaging (CT or MRI) evidence of hemorrhage deemed significant by the treating physician (\\> grade 1). Subjects with significantly increased risk of CNS hemorrhage are not eligible.\n* Concurrent use of anti-coagulant drugs (not including prophylactic doses), history of coagulopathy, or evidence of bleeding diathesis or coagulopathy.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia.\n* Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis.\n* Immune related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy was recommended (per product label or consensus guidelines) or any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well controlled on replacement hormones).\n* Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\\> 10 mg\u002Fday of prednisone or equivalent).\n\n  1. Physiologic corticosteroid replacement therapy at doses ≤ 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.\n  2. Participants with asthma that requires intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections may participate.\n  3. Participants using topical, ocular, intra-articular, or intranasal corticosteroids (with minimal systemic absorption) may participate.\n  4. Brief courses of corticosteroids for prophylaxis (eg, contrast dye allergy) or study treatment-related standard premedications are permitted.\n* Active infections requiring systemic antibiotics or antifungal or antiviral treatment within 10 days before first dose of study treatment.\n* Has received a live vaccine within 28 days before the planned start of study treatment (with the exception of COVID-19 vaccines).\n\nNote: Examples of live vaccines include but are not limited to measles, mumps, rubella, varicella-zoster (chickenpox), yellow fever, rabies, BCG, and typhoid vaccines. Seasonal influenza vaccines for injection are generally killed-virus vaccines and are allowed; however, intranasal influenza vaccines are live, attenuated vaccines and are not allowed.\n\n* History of organ transplant, including allogeneic stem cell transplantation.\n* Clinically significant cardiovascular disease, such as:\n* Inadequately controlled HTN (defined as an average systolic blood pressure \\>160 or an average diastolic blood pressure \\> 100 for adult patients ≥ 21 years and as an average systolic BP \\> 130 or an average diastolic blood pressure \\>80 for pediatric patients 12-21 years) despite adequate treatment with medications. Patients with hypertension should be under treatment on study entry to control blood pressure.\n* History of CVA within 12 months of registration\n* Myocardial infarction or unstable angina within 12 months of registration\n* New York heart association grade II or greater congestive heart failure\n* Serious and inadequately controlled cardiac arrhythmia\n* Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection)\n* Clinically significant peripheral vascular disease","ALL","12 Years",{"count":19,"type":20},109,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a multi-arm phase II platform-basket screening study designed to test multiple experimental therapies simultaneously in patients with NF2-related schwannomatosis (NF2-SWN, formerly known as neurofibromatosis type 2) with associated progressive tumors of vestibular schwannomas (VS), non-vestibular schwannomas (non-VS), meningiomas, and ependymomas.\n\nThis Master Study is being conducted as a \"basket\" study that may allow people with multiple tumor types associated with NF2-SWN to receive new drugs throughout this study. Embedded within the Master Study are individual drug substudies.\n\n* Investigational Drug Sub-study A: Brigatinib\n* Investigational Drug Sub-study B: Neratinib\n* Investigational Drug Sub-study C: Retifanlimab plus bevacizumab",[26,27,28,29,30],"Neurofibromatosis Type 2","Vestibular Schwannoma","Non-vestibular Schwannoma","Meningioma","Ependymoma",[32,33,34,35,36],"neurofibromatosis type 2 (NF2)","vestibular schwannomas (VS)","non-vestibular schwannomas (non-VS)","meningioma","ependymoma","RECRUITING","2026-05-04",{"date":40,"type":41},"2026-05-06","ACTUAL",{"date":43,"type":41},"2020-06-20",{"date":45,"type":20},"2030-12-01",{"name":47,"class":48},"Scott R. Plotkin, MD, PhD","OTHER",6,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100555884","phase-1-anti-vegf-gene-therapy-trial-for-vestibular-schwannoma-100555884","NCT06517888","Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma","A Phase 1\u002F2 Trial of AAVAnc80-antiVEGF Gene Therapy in Individuals With Unilateral Vestibular Schwannoma","Criteria for Inclusion:\n\n1. Presence of unilateral, progressive vestibular schwannoma.\n2. Vestibular schwannoma larger than 2 mm.\n3. Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the affected ear.\n4. Able and willing to comply with all trial requirements, including willingness to participate in a separate long term follow-up study after completion of this trial.\n\nCriteria for Exclusion:\n\n1. Prior diagnosis of NF2 and\u002For bilateral vestibular schwannoma.\n2. Prior surgery or radiation therapy for vestibular schwannoma.\n3. Clinical history consistent with endolymphatic hydrops (documented fluctuating sensorineural hearing loss and\u002For episodic vertigo) in the affected ear.\n4. Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the unaffected ear.\n5. Prior participation in a clinical trial with an investigational drug within six months prior to administration (Day 0), or any prior participation in a gene therapy clinical trial.","18 Years",{"count":59,"type":20},27,[61,23],"PHASE1","This trial will evaluate the safety and tolerability of a single unilateral administration of one of three dose levels of AAVAnc80-antiVEGF and will evaluate the Akouos delivery device to safely achieve the intended product performance.",[27],[65,66,67,68],"Vestibular schwannoma","Hearing loss","Acoustic neuroma","anti-VEGF","2026-04-01",{"date":71,"type":41},"2026-04-06",{"date":73,"type":41},"2025-01-17",{"date":75,"type":20},"2029-08",{"name":77,"class":78},"Akouos, Inc.","INDUSTRY",4,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100493253","evaluating-pre-treatment-vestibular-physical-therapy-rehab-for-patients-with-vestibular-schwannomas-100493253","NCT05702749","Evaluating Pre-Treatment Vestibular Physical Therapy Rehab for Patients With Vestibular Schwannomas","VS PREHAB","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Male or female participants ≥18 years of age.\n3. Initial diagnosis of a Vestibular Schwannoma confirmed by a physician with an internal auditory canal (IAC) MRI, in accordance with standard or institutional practice\n4. VS patients who present with a tumor size ≤2.5 cm and will be treated with surgery or SRS\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status \\\u003C2\n6. Within 14 days of study registration, participants must have normal laboratory values that support safe treatment, at the discretion of the treating investigator\n7. Be willing to adhere to outlined study protocol criteria and complete self-reported questionnaires (translations may be made available if the patient' primary language is not English).\n8. For females of reproductive potential: must have a negative urine or serum pregnancy test 7 prior to enrollment and agreement to use of highly effective contraception method during study participation and for an additional 24 weeks after the completion of stereotactic radiosurgery.\n\nExclusion Criteria:\n\n1. Subjects less than 18 years of age\n2. Prior treatment of VS including radiotherapy or surgery or treatment for disease recurrence or planned salvage procedure\n3. Pre-existing, secondary vestibular diagnoses (e.g., Meniere's, intractable benign paroxysmal positional vertigo (BPPV), vestibular migraine, 3PD).\n4. Other medical comorbidities know to significantly impair\u002Faffect balance and\u002For vestibular function testing (e.g., prior stroke, uncorrected visual impairment or blindness, etc.)\n5. Anticipated radiation other than stereotactic (fractionated)\n6. Inability to undergo MRI scans safely\n7. Allergy to Gadolinium contrast used for MRI scans\n8. Women of childbearing potential who are known to be pregnant or are unwilling to use an acceptable method of contraception from the time of informed consent until completion of study related treatment and additional 24 weeks following stereotactic radiosurgery administration.",{"count":88,"type":20},36,[90],"NA","The study is a pilot efficacy study. The investigators aim to estimate mean baseline and post-treatment balance scores among Vestibular Schwannomas (VS) patients undergoing pretreatment rehab (PREHAB) or no PREHAB when managed with either surgery or radiosurgery.",[27],[94,27,95],"stereotactic radiosurgery","sensory organization test","2026-03-20",{"date":98,"type":41},"2026-03-24",{"date":100,"type":41},"2024-01-22",{"date":102,"type":20},"2027-12",{"name":104,"class":48},"Medical College of Wisconsin",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":105},"100621002","vestibular-rehabilitation-protocol-in-unilateral-vestibular-schwannoma-100621002","NCT07364955","Vestibular Rehabilitation Protocol in Unilateral Vestibular Schwannoma","Prospective Comparative Clinical Study of Three Parallel Cohorts on the Efficacy of Pre- and Post-surgical Vestibular Rehabilitation With or Without Rotary Stimulation in Patients With Vestibular Schwannoma","Inclusion Criteria:\n\n* Age between 18 and 70 years\n* Tumor size between 1.5 cm and 4 cm\n* Unilateral vestibular schwannoma\n\nExclusion Criteria:\n\n* Degenerative neurological conditions\n* History of cerebrovascular disease\n* Musculoskeletal deformities","70 Years",{"count":115,"type":20},75,[90],"Brief Summary\n\nThe purpose of this clinical trial is to evaluate whether different strategies of vestibular rehabilitation, performed before and after surgery, can improve recovery in adults diagnosed with unilateral vestibular schwannoma. The main questions the study aims to answer are:\n\nDoes preoperative vestibular telerehabilitation improve postoperative vestibular compensation compared with no intervention?\n\nDoes adding preoperative rotatory chair stimulation to telerehabilitation lead to greater improvements in balance, dizziness, or hospital length of stay?\n\nThe study includes three comparison groups:\n\nNo-intervention group: Participants do not receive pre- or postoperative rehabilitation, but complete all study assessments (vHIT, DHI, posturography, and hospital length of stay).\n\nTelerehabilitation group: Participants complete a structured home-based vestibular telerehabilitation program (ReHub) for 3 weeks before surgery and again for 3 weeks after surgery.\n\nRotatory Chair + Telerehabilitation group: Participants receive the same telerehabilitation program as the telerehabilitation group, plus six supervised sessions of preoperative rotatory chair stimulation (two sessions per week for three weeks), following a progressive protocol in the ENT department using a CE-marked clinical rotatory chair.\n\nParticipants will:\n\nAttend routine preoperative and postoperative assessments (vHIT, posturography, and DHI).\n\nComplete home-based vestibular exercises through a digital telerehabilitation platform (Groups 2 and 3).\n\nIf assigned to the Rotatory Chair + Telerehabilitation group, attend six in-hospital sessions of controlled rotatory chair stimulation during the three weeks before surgery.\n\nUndergo follow-up evaluations at 4 and 12 weeks after surgery.\n\nThis study aims to determine whether structured vestibular training conducted before and after surgery can enhance postoperative compensation and reduce symptom burden in patients undergoing vestibular schwannoma surgery.",[27,119],"Vestibular Schwannomas",[121,122,123],"Vestibular rehabilitation","Vestibular prehabilitation","Vestibular prehab","2026-01-18",{"date":126,"type":41},"2026-01-23",{"date":128,"type":41},"2025-09-01",{"date":130,"type":20},"2027-12-31",{"name":132,"class":48},"Albert Torrents Torrero",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":141,"sex":16,"minAge":142,"maxAge":113,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100487074","stableeyes-with-active-neurofeedback-100487074","NCT05622344","StableEyes With Active Neurofeedback","StableEyes With Active Neurophysiological Feedback","SWAN","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. In good general health as evidenced by medical history or diagnosed with unilateral vestibular schwannoma\n4. Willing to adhere to the SWAN and\u002For vestibular rehabilitation regimen\n\nExclusion Criteria:\n\n1. Current use of anti-nausea medication\n2. Presence of cervical spine pathology that limits head motion to \\\u003C 30 degrees in the horizontal or vertical plane (i.e. degenerative disc disease, rheumatoid arthritis)\n3. Any orthopedic pathology that prevents walking or standing independently (i.e. recent surgery)\n4. Legal blindness (20\u002F200 or worse visual acuity)\n5. Treatment using a motion sickness investigational drug or other motion sickness behavioral intervention within 30 days",true,"21 Years",{"count":144,"type":20},48,[90],"The investigators have developed a self-administered rehabilitation tool that incrementally guides the user to increase head motion to mitigate motion sickness and enhance postural recovery following centrifugation or unilateral vestibular nerve deafferentation surgery.",[148,27,149,150],"Vestibular Disorder","Space Motion Sickness","Motion Sickness","2025-11-06",{"date":153,"type":41},"2025-11-10",{"date":155,"type":41},"2022-08-08",{"date":157,"type":20},"2026-09-30",{"name":159,"class":48},"Johns Hopkins University",2,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":21,"phases":172,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":183,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":188,"leadSponsor":190,"locationsCount":105},"100601923","phase-3-steroids-for-facial-nerve-function-protection-in-post-surgical-vestibular-schwannoma-patients-100601923","NCT07116811","Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients","The Effect of Steroids Treatment for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients (SAF-NRVS): a Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Trial","SAF-NRVS","Inclusion Criteria:\n\n1. Age between 18 and 60 years\n2. Diagnosed with untreated unilateral vestibular schwannoma\n3. No facial palsy before surgery (House-Brackmann grade I)\n4. Intraoperative neurophysiological monitoring confirms good facial nerve function preservation, defined as: a）Post-tumor resection, evoked compound muscle action potential amplitude \\>420 μV under 0.05 mA stimulation；and b）The amplitude is \\>60% of baseline value measured before dural opening\n5. Signed informed consent\n\nExclusion Criteria:\n\n1. Contraindications for craniotomy\n2. Patients requiring corticosteroids during the perioperative period, or with known corticosteroid contraindications\n3. Patients or first-degree relatives with a confirmed diagnosis of neurofibromatosis type 2 (NF2)\n4. Karnofsky Performance Status (KPS) score \\\u003C90 before disease onset\n5. Pregnant or planning to become pregnant during the study period\n6. Participation in other interventional clinical trials\n7. Judged unsuitable by the investigators","60 Years",{"count":171,"type":20},364,[173],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of steroids treatment compared with placebo in preserving facial nerve function after craniotomy in patients with vestibular schwannoma who have not received preoperative treatment and have good intraoperative facial nerve function.",[27,176],"Facial Nerve Paralysis",[178,179,180,181,182],"Steroids","Facial Nerve Function","Intraoperative Neurophysiological Monitoring","Randomized Controlled Trial","Facial Palsy","NOT_YET_RECRUITING","2025-08-07",{"date":186,"type":41},"2025-08-12",{"date":128,"type":20},{"date":189,"type":20},"2027-09-30",{"name":191,"class":48},"Beijing Tiantan Hospital",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":21,"phases":202,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":105},"100566815","early-rehabilitation-using-head-impulse-test-for-acute-vestibular-deficit-100566815","NCT06660082","Early Rehabilitation Using Head Impulse Test for Acute Vestibular Deficit","KINE HIT","Inclusion Criteria:\n\n* patients with unilateral vestibular schwannoma and programmed surgery\n* vestibulo-ocular reflex gain :\n\n  * on pathological side \\> 0.50\n  * on healthy side \\> 0.80\n* all information's concerning the study given more than 15 days before surgery and consent collected the day before surgery\n\nExclusion Criteria:\n\n* Radiotherapy treatment prior to surgery.\n* Resumption of surgery\n* Presence of bilateral vestibular schwannomas\n* Normal or Corrected to normal distance visual acuity \\\u003C 5\u002F10\n* Presence of other aetiologies that may explain the ataxic syndrome and\u002For oscillopsias\n* Oculomotor paralysis, ocular instability in primary position\n* Use of medications that compromise eye movement (psychotropic drugs)\n* Cervical spinal pathology with instability (contraindication for vHIT)\n* Cochlear implantation\n* Non-stabilized medical condition\n* Pregnant women. This exclusion criterion will be investigated by questioning the patient.\n* Patient under guardianship\n* Patient not affiliated to a social security scheme\n* Patient participating any other interventional study","65 Years",{"count":201,"type":20},26,[90],"The vestibulo-ocular reflex (VOR) induces a compensatory movement in the eye when the head is rotated, to maintain stable vision when we move. It originates in the peripheral vestibular system, which detects head movements. It is particularly effective for rapid head movements, as tested in the Head Impulse Test (HIT). In acute unilateral vestibular deficit (AUVD), the VOR deficit is compensated for by a substitution saccade, more commonly known as catch up saccade, that contribute to refocus the gaze and maintain vision during head rotations.\n\nRecent technological advances have made it possible to make high-quality recordings during HIT (video Head Impulse Test, vHIT), leading to the identification of substitution saccades of variable latency. Our team has shown that saccades of shorter latency lead to better visual function (Hermann et al., 2017) and that the cerebellum is involved in the development of these saccades (Hermann et al., 2023), suggesting a learning effect rather than the de novo appearance of particular saccades.\n\nThe main hypothesis of this study is that the mechanisms underlying short-latency substitution saccades, which seems to guarantee good functional recovery, depend on learning occurring from the first days after an acute unilateral vestibular deficit. We also hypothesise that early physiotherapeutic rehabilitation of the VOR under Head Impulse Test conditions would promote this learning process and the development of early catch-up saccades.\n\nOne of the causes of AVD is the resection of cochleovestibular schwannomas. This procedure involves a neurotomy, i.e. complete vestibular deafferentation, which is precisely known due to the scheduled nature of the surgery. The exact moment of onset of vestibular damage is therefore known, unlike other vestibular pathologies. Hospitalisation is necessary in the immediate aftermath of surgery, with the presence of physiotherapists on the wards. In addition, there is no spontaneous recovery of the vestibular deficit. These patients therefore represent the ideal acute unilateral vestibular deficit model for testing our hypothesis. Two studies using vHIT in the aftermath of vestibular schwannoma resection surgery (Pogson et al. 2022; Mantokoudis et al. 2014) also allow us to confirm the safety and feasibility of our protocol in this patient population.",[27,205],"Unilateral Vestibular Deficit",[121,65,207,208],"Vestibulo-ocular Reflex (VOR)","video Head Impulse Test (vHIT)","2025-05-14",{"date":211,"type":41},"2025-05-16",{"date":213,"type":41},"2025-05-13",{"date":215,"type":20},"2027-05",{"name":217,"class":48},"Hospices Civils de Lyon",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":226,"phases":4,"briefSummary":227,"conditions":228,"keywords":230,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":105},"100488540","radiosurgery-induced-ototoxicity-in-patients-treated-for-a-vestibular-schwannoma-100488540","NCT05641441","Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma","Inclusion Criteria:\n\n* Aged 18 years or above\n* Patients with unilateral VS treated either with SRS or MRI-based observation strategy, as proposed by the institution's skull base tumor board independently of the study\n* Patients willing to take part in the study and give their informed consent\n\nExclusion Criteria:\n\n* Previous surgical or radiation therapy for VS (including SRS)\n* Patients diagnosed with neurofibromatosis type II\n* Preexisting profound hearing loss, with a pure tone average (PTA) \\>90 and word recognition score (WRS) \\\u003C10%, upon initial assessment\n* Previous middle ear surgery of the affected ear\n* Concurrent treatment with other experimental drugs",{"count":225,"type":20},258,"OBSERVATIONAL","The investigators aim to study the impact of stereotactic radiosurgery, for the treatment of vestibular Schwannoma, on the cochlear, vestibular, gustatory, and facial nerve functions and compare it with a conservatively treated group. The predictive value of radiological tumor characteristics on hearing preservation and vestibular function will be also evaluated.\n\nAdditionally, the investigators will invite patients with vestibular Schwannoma to fill out questionnaires to assess their quality of life.",[27,229],"Ototoxicity",[231,229,27,66,232],"Radiosurgery","Quality of Life","2025-01-09",{"date":235,"type":41},"2025-01-13",{"date":237,"type":41},"2023-01-24",{"date":239,"type":20},"2030-11-15",{"name":241,"class":48},"University Hospital, Geneva",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":226,"phases":4,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":105},"100342968","cochlear-implantation-after-gamma-knife-radiosurgery-with-eabr-and-correlation-to-postoperative-hearing-results---a-pilot-study-100342968","NCT03745534","Cochlear Implantation After Gamma Knife Radiosurgery with EABR and Correlation to Postoperative Hearing Results - a Pilot Study","Inclusion Criteria:\n\n* Patients who have undergone radio surgery for vestibular schwannoma\n* Patients wanting cochlear implantation for hearing rehabilitation\n\nExclusion Criteria:\n\n* Patients not wanting to participate in the study",{"count":249,"type":20},8,"Patients undergoing cochlear implantation after radio surgery for vestibular schwannoma will be included in the study. Patients will undergo preoperative and intraoperative eABR measurement. Correlations to postoperative hearing results will be drawn.",[27,252],"Hearing Loss","2024-11-21",{"date":255,"type":41},"2024-11-25",{"date":257,"type":41},"2018-08-01",{"date":259,"type":20},"2026-10-30",{"name":261,"class":48},"Christoph Arnoldner",{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":269,"enrollmentInfo":270,"targetDuration":4,"studyType":226,"phases":4,"briefSummary":272,"conditions":273,"keywords":274,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":105},"100342970","intraoperative-eabr-for-decision-making-100342970","NCT03745560","Intraoperative EABR for Decision Making","Simultaneous Translabyrinthine Surgery of Vestibular Schwannoma and Cochlear Implantation with Intraoperative EBERA and Correlation to Hearing Results - a Pilot Study","Inclusion Criteria:\n\n* Patients between 18 and 99 years undergoing translabyrinthine vestibular schwannoma resection\n* Patients wanted hearing rehabilitation with a cochlear implant\n\nExclusion Criteria:\n\n* patients who do not want to be part of the study","99 Years",{"count":271,"type":20},15,"In this study patients undergoing simultaneous translabyrinthine vestibular schwannoma resection and cochlear implantation are included. The goal of the study is to correlate the eABR results with postoperative hearing results.",[27,252],[275],"Cochlear implant",{"date":255,"type":41},{"date":278,"type":41},"2017-05-23",{"date":280,"type":20},"2026-05-23",{"name":261,"class":48},{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":141,"sex":16,"minAge":57,"maxAge":290,"enrollmentInfo":291,"targetDuration":4,"studyType":21,"phases":293,"briefSummary":294,"conditions":295,"keywords":298,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":105},"100524728","evolution-of-vestibular-function-after-treatment-of-a-vestibular-schwannoma-by-gamma-knife-radio-surgery-100524728","NCT06112509","Evolution of Vestibular Function After Treatment of a Vestibular Schwannoma by Gamma-knife Radio-surgery","Evolution of Vestibular Function After Treatment of a Vestibular Schwannoma by Gamma-knife","EVERS","Inclusion Criteria :\n\n* Men and women aged 18 to 90 included\n* Subject who benefited from gamma-knife radiosurgery as part of the treatment of vestibular schwannoma\n* Non-opposition of the subject to participate in the study\n* Affiliation to a French social security scheme or beneficiary of such a scheme\n\nExclusion Criteria :\n\n* Subject with another vestibular pathology\n* Subject who did not benefit from a vestibular assessment before treatment with gamma-knife radiosurgery\n* Legal incapacity or limited legal capacity\n* Subject unlikely to cooperate in the study and\u002For weak cooperation anticipated by the investigator\n* Subject without health insurance\n* Subject being in the period of exclusion from another study or provided for by the \"national volunteer file\".","90 Years",{"count":292,"type":20},20,[90],"The purpose of this study is to evaluate the vestibular effects of gamma-knife radiosurgery, as part of the treatment of vestibular schwannoma.",[27,296,297],"Neurinoma, Acoustic","Acoustic Neuroma",[299,300,301,302,303,304],"vestibular","schwannoma","radiosurgery","gamma-knife","neurinoma","acoustic","2024-09-05",{"date":307,"type":41},"2024-09-19",{"date":309,"type":41},"2024-02-20",{"date":311,"type":20},"2024-11-01",{"name":313,"class":48},"Centre Hospitalier Universitaire de Besancon",{"id":315,"slug":316,"hasResults":11,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":16,"minAge":322,"maxAge":323,"enrollmentInfo":324,"targetDuration":4,"studyType":21,"phases":326,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":105},"100560079","uspio-enhanced-mr-imaging-in-cns-tumours-umic-100560079","NCT06572475","USPIO Enhanced MR Imaging in CNS Tumours (UMIC)","USPIO Enhanced MR Imaging in CNS Tumours (UMIC) : A Pilot Study of Ferumoxytol (Feraheme ©) as an Imaging Biomarker of Tumour Associated Macrophage (TAM) Infiltration in Vestibular Schwannoma (VS) and Transforming Low Grade Glioma (LGG)","UMIC","Inclusion Criteria:\n\n* Be at least 16 years old\n* Have a CNS tumour suspected to be one of the defined histological types (vestibular scwhannoma or low grade glioma)\n* Be able to lie still for up to 1 hour comfortably\n* Opinion of the treating clinician is that the patient will be able to successfully complete the research imaging protocol.\n\nExclusion Criteria:\n\n* Life expectancy less than 1 year\n* Previous CNS radiotherapy\u002F stereotactic radiosurgery (SRS)\n* Females who are pregnant\u002F breastfeeding\n* Patients with an eGFR \\\u003C 30ml\u002Fmin\n* Patients with known and documented history of iron overload\u002Fhaemosiderosis\u002F haemochromatosis\n* Patients with immune or inflammatory conditions e.g. systemic lupus erythematous, rheumatoid arthritis\n* Patients with absolute (e.g. pacemaker) and relative (anxiety or claustrophobia) contraindications to MR scanning\n* Patients with a history of allergic reaction to iron or dextran\n* Patients with a history of allergic reaction to gadolinium contrast agents, asthma or renal problems\n* Patients who are unable to adequately understand verbal explanations or written information given in English.","16 Years","100 Years",{"count":325,"type":20},17,[90],"The immune response or inflammation is known to be a key driver of progression and growth in many solid tumours. Inflammatory cells called macrophages are present in high numbers in many brain tumours and these tumour associated macrophages or TAM are thought to have prognosis and treatment implications in these tumours. A key question, however, is how this inflammation or TAM abundance can be detected, measured and monitored in the clinic. A clinically applicable imaging test that can directly and accurately measure tumour macrophage content would be of considerable value and one technique that may provide this is USPIO enhanced magnetic resonance imaging (MRI). Following intravenous injection, USPIO or ultrasmall superparamagnetic iron oxide nanoparticles, circulate in the bloodstream before being taken up by inflammatory cells\u002Fmacrophages in tumour tissue, wherein they can be detected by MRI. This pilot study is to evaluate if a commercially available USPIO preparation called ferumoxytol (Feraheme ©) can accurately quantify macrophage abundance in brain tumours, with an exploratory focus on vestibular schwannoma (VS) and suspected transforming low-grade glioma (LGG). Patients with both non-growing (static) and growing VS, and patients with suspected transforming LGG will undergo dedicated MRI sequences before, immediately after (\\\u003C 2 hours) and at both 24 and 48hrs after ferumoxytol administration. In patients undergoing surgery, acquired imaging will be compared with resected tumour tissue so that markers of inflammation can be compared with USPIO uptake. Through advanced laboratory methods this study will seek to establish within resected VS and LGG specimens: the cellular destination\u002Fs of USPIO uptake; the nature of the inflammatory and\u002For tumour cells containing the USPIO; and the relationship between USPIO uptake and tumour blood vessel permeability or leakiness.",[27,329],"Glioma, Astrocytic","2024-08-22",{"date":332,"type":41},"2024-08-27",{"date":334,"type":41},"2024-04-26",{"date":336,"type":20},"2026-12-31",{"name":338,"class":48},"Northern Care Alliance NHS Foundation Trust",{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":199,"enrollmentInfo":347,"targetDuration":4,"studyType":21,"phases":349,"briefSummary":350,"conditions":351,"keywords":352,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":105},"100428460","evolution-of-balance-and-vestibular-function-in-patients-treated-with-gammaknife-radiosurgery-for-vestibular-schwannoma-100428460","NCT04859335","Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma","Prospective Study : Long-term Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma EQUI-GAMMA","EQUI-GAMMA","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",{"count":348,"type":20},50,[90],"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.",[27],[27,353,354,355],"Gammaknife radiosurgery","Dizziness","Balance","2024-08-01",{"date":358,"type":41},"2024-08-02",{"date":360,"type":41},"2021-05-21",{"date":362,"type":20},"2028-12-01",{"name":364,"class":48},"University Hospital, Toulouse"]