[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"idiopathic-intracranial-hypertension-iih\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:idiopathic-intracranial-hypertension-iih":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,72,101,131,159,185,210],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100643104","phase-3-eptinezumab-for-chronic-headache-in-idiopathic-intracranial-hypertension-100643104",false,"NCT07645833","Eptinezumab for Chronic Headache in Idiopathic Intracranial Hypertension","Prevention of Chronic Headache in Patients Diagnosed With Idiopathic Intracranial Hypertension With a Monoclonal Anti-calcitonin Gene-related Peptide Antibody: A Double-blinded Randomized Placebo-controlled Multicentre Trial","PRIMA","Inclusion Criteria:\n\n* Female, aged 18 to 55 years\n* Diagnosis of idiopathic intracranial hypertension (IIH) or IIH without papilledema\n* Chronic headache associated with IIH\n* At least 15 headache days per monthduring the screening period\n* At least 8 migraine-like headache days per month during the screening period\n* Use of effective contraception througout the trial period and for at least 5 months after last administration of study drug\n\nExclusion Criteria:\n\n* Non-compliance with headache diary completion during screening, defined as less than 80% of the days reported\n* Contraindications to receiving eptinezumab according to the Summary of Product Characteristics\n* Previous or current treatment with anti-CGRP monoclonal antibodies within 5 half-lives\n* Previous insufficient or non-effective treatment with eptinezumab\n* Pregnancy, breastfeeding, or planning pregnancy during the sudy period","FEMALE","18 Years","55 Years",{"count":21,"type":22},96,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The goal of this clinical trial is to learn if eptinezumab can reduce headache frequency and headache-related disability in adults with idiopathic intracranial hypertension (IIH) and chronic headache. It will also evaluate the safety and tolerability of eptinezumab in this patient population.\n\nThe main questions it aims to answer are:\n\n* Does eptinezumab reduce the number of monthly moderate-to-severe headache days compared with placebo?\n* Does eptinezumab improve headache-related disability and patient-reported outcomes?\n* What adverse events occur during treatment with eptinezumab?\n\nResearchers will compare eptinezumab to placebo to determine whether eptinezumab is effective in the prevention of chronic headache in patients with IIH.\n\nParticipants will:\n\n* Receive eptinezumab or placebo according to random assignment.\n* Attend scheduled study visits and clinical assessments.\n* Complete headache diaries and questionnaires during the study period.\n* Undergo study-related examinations and collection of biological samples, including blood samples.",[28],"Idiopathic Intracranial Hypertension (IIH)","NOT_YET_RECRUITING","2026-06-09",{"date":32,"type":33},"2026-06-12","ACTUAL",{"date":35,"type":22},"2026-06-22",{"date":37,"type":22},"2029-01",{"name":39,"class":40},"Rigmor Højland Jensen","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100636098","stenting-of-symptomatic-cerebral-sinus-stenosis-with-the-lasercut-self-expanding-silance-stent-100636098","NCT07561268","Stenting Of Symptomatic Cerebral siNus stenosIs With the laserCut Self-expanding SILANCE Stent","SONIC","Inclusion Criteria:\n\n* Diagnosis of idiopathic intracranial hypertension (IIH) according to the Modified Dandy Criteria.\n* Cerebrospinal fluid (CSF) lumbar puncture opening pressure \\> 25 cm H₂O.\n* Presence of lateral venous sinus stenosis confirmed by venous magnetic resonance angiography (MRA) or venous computed tomography angiography (CTA).\n* Presence of clinical symptoms consistent with IIH, including headaches, visual field loss, papilledema or pulsatile tinnitus.\n* Venous pressure gradient across the stenosis \\> 3 mmHg under general anaesthesia, \\> 4 mmHg under local anaesthesia.\n* Temporal Bone CT done for Patients suffering from Pulsatile Tinnitus\n* Written informed consent obtained prior to any study-related procedures.","ALL",{"count":50,"type":22},99,[52],"NA","The objective of this clinical investigation is to evaluate and demonstrate the clinical benefit, performance, and safety of the SILANCE Stent, which is specifically designed for the treatment of patients with symptomatic sinus stenoses associated with IIH.",[28],[56,57,58,59,60,61],"Symptomatic venous sinus stenosis","IIH","Sinus stenosis","Lateral Sinus Stenosis","Sinus Stenting","Idiopathic intracranial hypertension","2026-04-28",{"date":64,"type":33},"2026-05-01",{"date":66,"type":22},"2026-09",{"date":68,"type":22},"2029-10",{"name":70,"class":71},"Acandis GmbH","INDUSTRY",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":48,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100586310","bmi-in-idiopathic-intracranial-hypertension-and-its-relationship-with-the-response-to-treatment-100586310","NCT06913712","BMI in Idiopathic Intracranial Hypertension and Its Relationship With the Response to Treatment","Evolution of Body Mass Index in Idiopathic Intracranial Hypertension and Its Relationship With the Response to Treatment. Retrospective and Prospective Study","Inclusion Criteria:\n\n* Adults aged 18 years and older at the time of enrollment. There is no upper age limit to ensure inclusivity across age ranges.\n* A confirmed diagnosis of Idiopathic Intracranial Hypertension, established according to the Dandy criteria.\n* The diagnostic process must exclude other potential causes of increased intracranial pressure as detailed in the 'Diagnosis' section, ensuring an accurate identification of idiopathic cases.\n\nExclusion Criteria:\n\n* A diagnosis other than IIH, specifically: tension-type headache, Chiari I malformation, or any other headache disorder unrelated to IIH.\n* The presence of secondary causes of increased intracranial pressure (e.g., structural brain abnormalities, venous sinus thrombosis, or medication-induced factors).",{"count":80,"type":22},25,"OBSERVATIONAL","1. To establish the correlation between the evolution of the body mass index in benign intracranial hypertension and the response to treatments.\n2. To establish the BMI at which this disease occurs.\n3. To establish how much the BMI must be reduced to cure this disease.\n4. To assess the evolution and response to treatments of sick people who DO NOT reduce or even continue to increase their BMI despite treatment with Acetazolamide or a possible CSF diversion",[28],[85,86,87,88,89],"Idiopathic Intracranial Hypertension","Body Mass Index","Lumboperitoneal Shunt","Ventriculoperitoneal Shunt","Acetazolamide","RECRUITING","2026-04-18",{"date":93,"type":33},"2026-04-22",{"date":95,"type":33},"2024-06-27",{"date":97,"type":22},"2028-05-01",{"name":99,"class":40},"University of Valencia",1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":48,"minAge":18,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100588780","venous-stenting-evaluation-in-patients-with-intracranial-hypertension-under-long-term-acetazolamide-100588780","NCT06945848","Venous Stenting Evaluation in Patients With Intracranial Hypertension Under Long-term Acetazolamide","Direct Intracranial Venous Stenting Evaluation in Patients With Idiopathic INtracranial Hypertension Under Long-term Treatment With AceTazolamidE With Inadequate Treatment Response","DIVEIINLATE","Inclusion Criteria:\n\n1. Subject is ≥ 18 years old at inclusion.\n2. Subject with definite diagnosis of IIH satisfying the modified Dandy criteria (A to E) ) at the time of initial diagnosis, under BMM including ACZ for more than 1 year\n3. Patient with elevated intracranial pressure defined as \\> 25 cm H20 or 18 mmHg\n4. Subject with intracranial TVS stenosis on dominant transverse sinus and hypoplastic contralateral one (or bilateral TVS stenosis) diagnosed on MRI\n5. Normal MRI findings excepted intracranial TVS stenosis or IIH related abnormalities\n6. Patient having received information about data collection and having signed and dated an Informed Consent Form\n7. Subjects must be able to attend all scheduled visits and to comply with all trial procedures\n8. Subjects must be covered by public health insurance\n\nExclusion Criteria:\n\n1. Patients receiving topiramate in the previous month\n2. Known contrast product, Nickel, titanium allergy\n3. Exposure to an oral drug (other than ACZ), substance, or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis (lithium, vitamin A, tetracycline and related compounds)\n4. History of intracranial venous thrombosis or intracranial neoplasia\n5. Fulminant decrease of visual acuity due to the IIH defined as a visual loss (of the most seriously impaired eye) of at least 3\u002F10 (from corrected vision) within 4 weeks, in absence of any other ophthalmologic pathology and Mean Deficit of visual field superior to -10 dB\n6. Optic nerve atrophy\n7. Amblyopia\n8. Refractive error greater ±8 sphere or more than ±3 in cylinder in either eye if there are abnormalities in funduscopy (optic disc tilt, staphyloma), previous glaucoma, other disorders causing visual loss\n9. Pregnancy: if a woman is of childbearing potential a urine or serum beta HCG test is positive\n10. Patient with a severe or fatal comorbidity that will likely prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.\n11. Evidence of intracranial hemorrhage (subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH), etc.)\n12. Life expectancy under 6 months\n13. Patients with renal failure (creatinine \\> 1.5 mg\u002Fdl and\u002For creatinine clearance \\\u003C 60 mL\u002Fmin, except if patient is already on hemodialysis)\n14. History of previously implanted intra-cranial sinus stent\n15. Previous gastric bypass surgery AAP-DGOS PHRC-N 22\\_0175 CHU DE MONTPELLIER Pr Costalat Vincent\u002FPr Ducros Anne Version n°2.2 date 25\u002F03\u002F2025 Page 28 sur 63\n16. Contra-indication to general anesthesia\n17. Contra-indication to aspirin, clopidogrel or other P2Y12 anti-aggregant\n18. History of chronic obstructive pulmonary disease or other severe respiratory disease\n19. History of deep vein thrombosis or pulmonary embolism\n20. History of atrial fibrillation or other risks of stroke\n21. Cerebral vascular lesions (arteriovenous malformation, arteriovenous fistula, aneurysms, significant stenosis of extra- or intra-cranial vessels other than the targeted venous sinus stenosis, intracranial artery dissection, etc.).\n22. Anatomical anomaly of the venous sinus which would prevent safe catheterization and stenting\n23. Subject who are in a dependency or employment with the sponsor or the investigator\n24. Participation in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date\n25. Subject protected according to the French Public Health Code (e.g. patients under law protection, prisoners, pregnant, parturient or lactating women, and patients under guardianship\u002Fcuratorship)",{"count":110,"type":22},114,[52],"This study is aimed at patients suffering from long term intracranial hypertension (caracterized by visual loss, chronic headache and\u002For tinnitus), receiving acetazolamide for more than 1 year, having inadequate response to treatment (untolerable side effects or insufficient efficacy).\n\nThe goal is to evaluate if stenting of a specific vein in the brain could decrease the hypertension and improve associated symptoms. Patients will be randomly assigned in either best medical care group (recommended medication associated with weight loss) or interventional group (best medical care + stenting of the specific vein) and will undergo specific follow-up visits after 1, 3 and 12 months.",[28],[115,116,117,118,119,120],"Intracranial hypertension","Papillary edema","Stenting","Transverse sinus vein","Chronic headache","Tinnitus","2026-03-05",{"date":123,"type":33},"2026-03-06",{"date":125,"type":33},"2026-01-05",{"date":127,"type":22},"2030-01-05",{"name":129,"class":40},"University Hospital, Montpellier",3,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":48,"minAge":18,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":23,"phases":142,"briefSummary":144,"conditions":145,"keywords":146,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":100},"100607693","phase-4-tirzepatide-in-idiopathic-intracranial-hypertension-trial-100607693","NCT07191873","Tirzepatide in Idiopathic Intracranial Hypertension Trial","A Phase IV Placebo-controlled Single Center Trial for Tirzepatide in Idiopathic Intracranial Hypertension Trial (TIIHT)","TIIHT","Inclusion Criteria:\n\n1. Signs and symptoms of increased intracranial pressure:\n\n   1. headaches, tinnitus, visual obscurations, papilledema;\n   2. absence of localizing findings on neurological examination (except for VI nerve palsy);\n   3. no secondary causes identified on imaging, e.g., hydrocephalus, space- occupying lesion;\n   4. elevated lumbar puncture (LP) opening pressure (OP) ≥25 cm H2O in lateral decubitus position with legs extended (\\>= (≥ 20cm H2O if one of the following is present: pulse synchronous tinnitus, abducens palsy, Frisen grade II papilledema, transverse venous sinus stenosis, partially empty sella or enlarged optic nerve sheath on magnetic resonance imaging (MRI);\n   5. the patient is awake and alert.\n2. BMI ≥30 kg\u002Fm2\n3. Age 18-60 years of age\n4. Unilateral or bilateral papilledema\n5. Able to provide informed consent\n6. Women of child-bearing age must use birth control (non-oral contraceptive method or add a barrier method of contraception).\n\nExclusion Criteria:\n\n1. Previous bariatric surgery\n2. Prior intervention for high ICP including optic nerve sheath fenestration (ONSF), venous stenting and\u002For shunting\n3. Taking another GLP-1 agonist, another drug that can interfere with the GLP-1 agonist, or any other anti-obesity medication\n4. History of pancreatitis, personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2), history of gallbladder disease, ulcerative colitis, Crohn's disease, or history of hypersensitivity reaction in response to the drug\n5. Pregnancy or planning a pregnancy in the next 12 months or currently breastfeeding\n6. Other disorders causing visual loss and\u002For anomalous optic nerve\n7. Taking another medication to lower ICP in IIH (if previously taking another medication for ICP must be off this medication for at least 30 days prior to enrollment)\n8. No change in headache medications in the past 60 days\n9. Venous sinus thrombosis on magnetic resonance venography (MRV)\n10. Papilledema Frisen Grade III, IV or fulminant IIH\n11. Mean perimetric deviation ≤ -7 dB\n12. CSF contents outside of normal limits\n13. Uncontrolled hypertension (≥140mmHg\u002F90 mmHg)\n14. Anemia (hemoglobin \\[Hgb\\] ≤ 8.0g\u002FdL)\n15. Diagnosed sleep apnea with continuous positive airway pressure (CPAP) use\n16. Exposure to a drug, substance, or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis such as lithium, vitamin A, various cyclines\n17. eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m2\n18. Type II diabetes","60 Years",{"count":141,"type":22},60,[143],"PHASE4","This will be a randomized, double-blind, parallel, placebo-controlled trial of 60 participants. The primary analysis will be a statistical comparison of the estimates of the mean difference in the 12-month change in intracranial pressure (ICP) between participants assigned to the tirzepatide and Placebo arms in 1:1 randomization using the intention-to-treat (ITT) population. Hypothesis testing will be performed using analysis of covariance (ANCOVA), with the treatment indicator as the independent variable and the 12-month change in ICP as the dependent variable. Models will include baseline ICP as a covariate. This primary endpoint will use a significance level of 0.05 to declare significance.",[28],[57,147,148,149],"BMI","Eye Pressure","Headache","2025-11-12",{"date":152,"type":33},"2025-11-14",{"date":154,"type":22},"2026-02",{"date":156,"type":22},"2028-02",{"name":158,"class":40},"Duke University",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":48,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":23,"phases":168,"briefSummary":169,"conditions":170,"keywords":171,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":130},"100586773","intracranial-venous-stenting-evaluation-in-patients-with-idiopathic-intracranial-hypertension-in-the-early-phase-100586773","NCT06919744","Intracranial Venous Stenting Evaluation in Patients With Idiopathic Intracranial Hypertension in the Early Phase","Direct Intracranial Venous Stenting Evaluation in Patients With Idiopathic INtracranial Hypertension in the Early Phase","DIVE IIN EARLY","Inclusion Criteria:\n\n1. Subject is ≥ 18 years old at inclusion.\n2. Subject with definite new diagnosis (˂ 3 months) of IIH satisfying the modified Dandy criteria (A to E)\n3. Subject with intracranial TVS stenosis on dominant transverse sinus and hypoplastic contralateral one (or bilateral TVS stenosis) diagnosed on MRI\n4. Normal MRI findings excepted intracranial TVS stenosis or IIH related abnormalities\n5. Subject with ophthalmologic IIH symptoms and signs (RNFL ≥ 130 µm, Frisen score ≥ 2, and absence of differential diagnostic)\n6. Subject without macular ganglion cells atrophy seen on OCT\n7. Patient having received information about data collection and having signed and dated an Informed Consent Form\n8. Subjects must be able to attend all scheduled visits and to comply with all trial procedures\n9. Subjects must be covered by public health insurance\n\nExclusion Criteria:\n\n1. Subject previously treated with acetazolamide for IIH\n2. Known contrast product, Nickel, titanium allergy\n3. Exposure to an oral drug, substance, or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis (lithium, vitamin A, tetracycline and related compounds)\n4. History of intracranial venous thrombosis or intracranial neoplasia\n5. Fulminant decrease of visual acuity due to the IIH defined as a visual loss (of the most seriously impaired eye) of at least 3\u002F10 (from corrected vision) within 4 weeks, in absence of any other ophthalmologic pathology and Mean Deficit of visual field superior to -10 dB\n6. Macular ganglion cells atrophy seen on OCT\n7. Optic nerve atrophy\n8. Amblyopia\n9. Refractive error greater ±8 sphere or more than ±3 in cylinder in either eye if there are abnormalities in funduscopy (optic disc tilt, staphyloma), previous glaucoma, other disorders causing visual loss\n10. Pregnancy: if a woman is of childbearing potential a urine or serum beta HCG test is positive\n11. Patient with a severe or fatal comorbidity that will likely prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.\n12. Evidence of intracranial hemorrhage (subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH), etc.)\n13. Life expectancy under 6 months\n14. Chronic IIH\n15. Patients with renal failure (creatinine \\> 1.5 mg\u002Fdl and\u002For creatinine clearance \\\u003C 60 mL\u002Fmin, except if patient is already on hemodialysis)\n16. History of previously implanted intra-cranial sinus stent\n17. Previous gastric bypass surgery\n18. Contra-indication to general anesthesia\n19. Contra-indication to aspirin, clopidogrel or other P2Y12 anti-aggregant\n20. History of chronic obstructive pulmonary disease or other severe respiratory disease\n21. History of deep vein thrombosis or pulmonary embolism\n22. History of atrial fibrillation or other risks of stroke\n23. Cerebral vascular lesions (arteriovenous malformation, arteriovenous fistula, aneurysms, significant stenosis of extra- or intra-cranial vessels other than the targeted venous sinus stenosis, intracranial artery dissection, etc.).\n24. Anatomical anomaly of the venous sinus which would prevent safe catheterization and stenting\n25. Subject who are in a dependency or employment with the sponsor or the investigator\n26. Participation in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date\n27. Subject protected according to the French Public Health Code (e.g. patients under law protection, prisoners, pregnant, parturient or lactating women, and patients under guardianship\u002Fcuratorship)",{"count":110,"type":22},[52],"This study is aimed at patients suffering from recently discovered intracranial hypertension, caracterized by visual loss, chronic headache and\u002For tinnitus. The goal is to evaluate if stenting of a specific vein in the brain could decrease the hypertension and improve associated symptoms. Patients will be randomly assigned in either best medical care group (recommended medication associated with weight loss) or interventional group (best medical car + stenting of the specific vein) and will undergo specific follow-up visits after 1, 3 and 12 months.",[28],[115,172,173,174,175,176],"papillary edema","stenting","transverse sinus vein","chronic headache","tinnitus","2025-10-02",{"date":179,"type":33},"2025-10-03",{"date":181,"type":33},"2025-09-19",{"date":183,"type":22},"2029-04-30",{"name":129,"class":40},{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":57,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":48,"minAge":18,"maxAge":19,"enrollmentInfo":192,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":194,"conditions":195,"keywords":197,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":100},"100589106","advanced-neuroimaging-in-idiopathic-intracranial-hypertension-100589106","NCT06950099","Advanced Neuroimaging in Idiopathic Intracranial Hypertension","Pathophysiological Evaluation of Idiopathic Intracranial Hypertension Using Glymphatic and Connectomic Imaging","Inclusion Criteria:\n\n• Refractory IIH patients who require and plan to have a venous sinus stenting\n\nExclusion Criteria:\n\n* History of head trauma and shunting or leak repair\n* Major concurrent, active non-cephalic pain syndrome\n* Contradictions for MRIs",{"count":193,"type":22},30,"Idiopathic intracranial hypertension (IIH) is characterized by elevated intracranial pressure leading to symptoms like papilledema, headache, and cognitive dysfunction. While the etiology is complex, abnormal cerebrospinal fluid dynamics due to venous outflow restriction from transverse sinus stenosis (TSS) is common. TSS may disrupt the glymphatic system, a brain-wide network facilitating cerebrospinal fluid and interstitial fluid exchange, by impairing CSF absorption, altering perivascular space dynamics, and disrupting pressure gradients crucial for waste clearance. Venous sinus stenting (VSS) can improve symptoms in many patients by alleviating venous congestion, but its effects on glymphatic function are unclear. This prospective study aims to evaluate novel quantitative brain imaging metrics as surrogate markers to better understand IIH pathophysiology before and after VSS in patients with refractory IIH and TSS. The investigators will use advanced MRI techniques, including MR elastography (MRE) to assess brain stiffness, diffusion tensor imaging (DTI) to evaluate water diffusion, arterial spin labeling (ASL) imaging to measure blood-brain barrier (BBB) permeability, and functional MRI to analyze pain networks. The investigators hypothesize that 1) these noninvasive imaging metrics will correlate with the degree of venous congestion and changes after venous sinus stenting (VSS) and 2) the imaging findings will correlate with clinical treatment outcomes. By correlating imaging markers with venous pressures and symptom changes, the investigators aim to gain insights into IIH mechanisms, expand diagnostic tools, and potentially guide clinical decision-making and treatment response monitoring. The overarching goal is to better understand IIH's underlying pathophysiology, which could lead to improved diagnostic criteria, more targeted treatments, and better prediction of treatment outcomes for patients with this challenging condition.",[28,196],"Glymphatic System",[198,199,200,57],"idiopathic intracranial hypertension","MRI","diffusion tensor imaging","2025-04-29",{"date":203,"type":33},"2025-05-02",{"date":205,"type":33},"2025-03-03",{"date":207,"type":22},"2025-12-31",{"name":209,"class":40},"Thomas Jefferson University",{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":217,"sex":48,"minAge":18,"maxAge":139,"enrollmentInfo":218,"targetDuration":4,"studyType":23,"phases":220,"briefSummary":221,"conditions":222,"keywords":223,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":100},"100580140","dural-venous-sinus-stent-in-idiopathic-intracranial-hypertension-100580140","NCT06833424","Dural Venous Sinus Stent in Idiopathic Intracranial Hypertension","Predictors of Dural Venous Sinus Stenting in Idiopathic Intracranial Hypertension Patients and Outcomes","Inclusion Criteria:\n\n* 40 Patients of idiopathic intracranial hypertension subjected to Dural venous sinus stenting met the modified Dandy criteria for (IIH).\n\n  1. Signs and symptoms of increased intracranial pressure: Headaches, nausea, vomiting, visual changes, and papilledema.\n  2. No localizing or focal neurologic signs: Except for possible unilateral or bilateral VI nerve paresis.\n  3. Elevated cerebrospinal fluid (CSF) pressure: Without cytologic or chemical abnormalities.\n  4. No etiology for increased intracranial pressure: On neuroimaging findings.\n\n     * Age: 18-60 years\n     * Gender: Male or Female Inclusion Criteria.\n\nExclusion Criteria\n\n1. Age less than or equal to 18 years.\n2. severe allergic reaction to iodine contrast or chronic Kidney disease.\n3. contraindication to general anesthesia or antiplatelet anticoagulants, Hemorrhagic Diathesis\n4. patients with secondary causes of intracranial hypertension: Dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow.\n5. pregnancy.",true,{"count":219,"type":22},40,[52],"This study aims to identify clinical determinants and factors that predict outcome including primary outcome and secondary outcome depending on factors in individual patients with Idiopathic intracranial hypertension treated by Dural venous sinus stenting.",[28],[224],"predictors and outcomes","2025-02-17",{"date":227,"type":33},"2025-02-18",{"date":229,"type":22},"2025-03-01",{"date":231,"type":22},"2026-07-01",{"name":233,"class":40},"Assiut University"]