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NCT ID: NCT06361823 Not yet recruiting - Clinical trials for Idiopathic Intracranial Hypertension

Exploratory Study on the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertension Treatment

Start date: May 1, 2024
Phase: Phase 3
Study type: Interventional

This study aims to investigate the safety and efficacy of semaglutide in patients with Idiopathic intracranial hypertension.

NCT ID: NCT06353412 Not yet recruiting - Clinical trials for IIH - Idiopathic Intracranial Hypertension

Current Treatment Methods of Idiopathic Intracranial Hypertension

Start date: June 1, 2024
Phase:
Study type: Observational

Aim of the study : 1. to determine the response to each treatment plan. 2. to determine when to choose specific treatment method. 3. to determine complication of each type of treatment method

NCT ID: NCT06059703 Not yet recruiting - Clinical trials for Idiopathic Intracranial Hypertension

Biomarkers in the Etiology of Idiopathic Intracranial Hypertension

BEHIND
Start date: November 6, 2023
Phase: N/A
Study type: Interventional

Idiopathic intracranial hypertension (IIH) is a condition characterized by an increase in intracranial pressure (ICP), papilledema with a risk of permanent visual loss, and severe headaches that profoundly affect quality of life. To date the exact pathophysiology of IIH remains unknown. IIH is considered a complex neurometabolic and neuroendocrine disorder, favored by female gender, and obesity. In the majority of patients (80% of the cases) IIH is associated with obstruction of cerebral venous drainage with stenosis of the transverse sinus. This stenosis may be the main underlying cause in the so-called "venogenic" form of IIH. Equally, in the absence of a stenosis, obstruction may occur when otherwise normal venous sinuses are compressed by the increased ICP, the so-called "non-venogenic" form of IIH. An innovative treatment of IIH with associated venous stenosis includes stenting of the transverse sinus stenosis. This strategy may allow resolution of papilledema and ICP reduction rates up to 80%. Although the pathogenesis of IIH is still poorly understood, inflammatory mechanisms, autoimmune reactions, and hormonal abnormalities of notably androgens, have been proposed to contribute to its pathophysiology. The function of the blood-brain barrier (BBB) has been studied by determining the prevalence of extravasation of endogenous proteins such as fibrinogen. A growing body of the literature shows a correlation between increased ICP and metabolic/hormonal changes. The improvement of IIH treated with acetazolamide and/or stenting appears to correlate with the reduction of ICP. Yet the association of this reduction with metabolic changes at the peripheral and central blood level as well as the CSF remains unclear. The search for specific inflammatory, immunological and hormonal biomarkers in patients with IIH and their variation in relation to the ICP should provide a better understanding of its etiology.

NCT ID: NCT06027567 Recruiting - Obesity Clinical Trials

The Effect of an Anti-obesity Drug, Semaglutide, as Treatment in New-onset Idiopathic Intracranial Hypertension (IIH) Compared to Standard Weight Management (Dietician) With Regards to Change in Weight and Intracranial Pressure

IIH:DUAL
Start date: September 2, 2022
Phase: Phase 4
Study type: Interventional

50 patients with verified new-onset Idiopathic Intracranial Hypertension are randomly allocated to standard weight management (dietician counselling) or trial intervention consisting of subcutaneous injections with Semaglutide for 10 months combined, in the initial 8 weeks following diagnosis, with a Very Low Calorie-Diet (max 800 kcal/day)

NCT ID: NCT05762367 Not yet recruiting - Clinical trials for Idiopathic Intracranial Hypertension

MR Lymphatic Imaging in Idiopathic Intracranial Hypertention

LYMPHIMAGIIH
Start date: March 10, 2023
Phase: N/A
Study type: Interventional

In the brain and its borders, blood vessels coexist with lymphatic vessels exclusively in the dura mater, the outermost layer of meninges. Dural lymphatics are present in various vertebrate species, including humans, and a cluster of experimental studies in the mouse strongly suggest their relevance in the pathophysiology of chronic and acute neurological disorders in humans. Demonstrating this assumption is however still at stake and the lymphatic regulatory mechanisms involved remain poorly characterized. Our main objective is to assess dural lymphatics contribution to the pathophysiology of a rare neurological disorder: idiopathic intracranial hypertension (IIH). In IIH patients, intracranial hypertension causes severe headache and visual loss and is associated with a stenosis of dural sinuses and abnormal retention of fluids in the central nervous system. Angioplasty treatment by stent placement into venous sinuses is frequently followed by recurrent stenosis suggesting that, in addition to the blood vessels, the duro-lymphatic environment contributes to disease progression. Several studies have found hot spots of lymphatic uptake at confluence points between cerebral veins and dural sinuses. Based on this premise, the investigators predict a causal link between lymphatic and venous behavior around dural sinuses and the remodeling of dural lymphatics in neurovascular conditions such as IIH. Our approach will combine radiological observations from human patients with experimental analyses in mouse models. The investigators have recently developed a technique of high resolution vessel wall imaging to explore and compare the lymphatic networks between individuals. This advanced MR-imaging technique has been validated through a translational study comparing the lymphatic networks in mice and humans (Jacob et al. 2022, JExpMed). Using this tool, the investigators aim to monitor dural lymphatic and sinus wall abnormalities in patients with IIH. In this view, cohorts of IIH patients and controls without neurological disorders (n = 20/cohort) will be scanned by MRI to perform high resolution vessel wall imaging of the dural lymphatics, sinus and cerebral veins.

NCT ID: NCT05707442 Recruiting - Clinical trials for Venous Sinus Stenosis

Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)

Start date: October 31, 2022
Phase: Phase 3
Study type: Interventional

The aim of this study is to assess the efficacy of stent implantation versus medical therapy on idiopathic intracranial hypertension with venous sinus stenosis.

NCT ID: NCT05647837 Recruiting - Clinical trials for Intracranial Hypertension

CSF Biomarkers in Idiopathic Intracranial Hypertension

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

Aim of the study is to high lighten the rule of CSF biomarkers in early diagnosis of IIH and in follow up to reach to a definite clinically based decision if this patient will improved on medical treatment or that patient is in need for surgical intervention.

NCT ID: NCT05397106 Recruiting - Brain Tumor Clinical Trials

Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

Start date: January 24, 2023
Phase:
Study type: Observational

Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.

NCT ID: NCT05347147 Terminated - Clinical trials for Idiopathic Intracranial Hypertension

A Trial to Determine the Efficacy and Safety of Presendin in IIH

IIH EVOLVE
Start date: November 18, 2022
Phase: Phase 3
Study type: Interventional

Idiopathic intracranial hypertension (IIH) has significant associated morbidity and reduced quality of life. There is a significant risk of visual loss and patients also typically suffer with chronic disabling headaches. This trial has been designed to evaluate the efficacy and safety of a new formulation of exenatide (Presendin) in the reduction of intracranial pressure (ICP) in patients with IIH.

NCT ID: NCT05308823 Enrolling by invitation - Clinical trials for Idiopathic Intracranial Hypertension

Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension

Start date: March 15, 2022
Phase: N/A
Study type: Interventional

The aim of the work is to asses the positive effect of stenotic sinus segment stenting on idiopathic intracranial hypertension with headache and papilloedema.