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Pseudotumor Cerebri clinical trials

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NCT ID: NCT06059703 Recruiting - Clinical trials for Idiopathic Intracranial Hypertension

Biomarkers in the Etiology of Idiopathic Intracranial Hypertension

BEHIND
Start date: November 27, 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: 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: NCT05050864 Recruiting - Cerebrospinal Fluid Clinical Trials

Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.

HYDROPTIC
Start date: March 2, 2022
Phase: N/A
Study type: Interventional

Idiopathic intracranial hypertension (HTICi) is a pathology, affecting young adults with a predominance of women, due to an increase in intracranial pressure, which may be associated with stenosis of the cerebral venous sinuses and whose origin remains unknown. This hypertension can lead to papillary edema (OP) which can lead to a narrowing of the visual field and progress to blindness. Along with weight reduction, acetazolamide, which reduces the production of cerebrospinal fluid (CSF), is prescribed as a first-line treatment. Its efficacy is inconsistent in resolving papillary edema and there are many side effects. In the event of ineffectiveness or dependence on acetazolamide associated with hygiene and dietetic rules, a second line of therapy is then considered: neurosurgical (internal shunt of the LCS) or endovascular (venous stenting) treatment. These invasive techniques have each proven their effectiveness in the rapid and permanent resorption of OP, allowing improvement or preservation of visual function. In terms of induced morbidity, the superiority of one technique over the other, if it exists, has not been established. Our objective is to compare the efficacy, safety, and safety of LCS bypass surgery versus venous sinus stenting in HTICi with moderate to severe visual impairment after failure of medical treatment defined by the absence of resorption of the OP after several months

NCT ID: NCT04309383 Recruiting - Pseudotumor Cerebri Clinical Trials

ShuntCheck Performance Characteristics in Asymptomatic Pseudotumor Cerebri Patients

Start date: October 29, 2019
Phase:
Study type: Observational

The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with pseudotumor cerebri.

NCT ID: NCT04115553 Recruiting - Clinical trials for Intracranial Hypertension

Assessment of Venous Drainage in Idiopathic Intracranial Hypertension

HYPERPIC
Start date: February 19, 2020
Phase: N/A
Study type: Interventional

Intracranial hypertension (IIH) is a disorder producing a syndrome of increased intracranial pressure secondary to a compressive intracranial lesion or said to be idiopathic. The most common symptoms are headaches, blindness, pulsatile tinnitus or papillary edema. There are many options for the treatment of IIH, especially neurosurgery (derivation of cerebrospinal fluid or stent placement). Currently, idiopathic IIH has no clear etiology but the hypothesis of sino-venous insufficiency is more and more recognized. The assumption of venous insufficiency has not been demonstrated so far. Therefore the investigators propose to demonstrate that cerebral venous drainage pathways are altered in adult patients with idiopathic intracranial hypertension in comparison to healthy individuals having normal circulation. Assessment will be performed using Magnetic Resonance Imaging which is part of the patient care.

NCT ID: NCT04032379 Recruiting - Clinical trials for Benign Intracranial Hypertension

Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension

Start date: February 14, 2018
Phase:
Study type: Observational [Patient Registry]

Idiopathic intracranial hypertension (IIH) is a condition of unknown etiology, primarily affecting overweight females of childbearing age. Typically, patients experience headache and visual symptoms due to increased intracranial pressure (ICP) and papilledema. The diagnosis is difficult, and outcomes vary from no sequelae to blindness or chronic headaches. No clear prognostic indicators exist. Treatment consists of medication, weight loss, and possibly surgical intervention.There is an unmet need of defining biomarkers with prognostic or diagnostic value and defining predictors of a poor outcome. This project is a prospective, population-based cohort study including clinical data and a biobank (blood samples and cerebrospinal fluid). The investigator's primary aim is to identify biomarkers of diagnostic or prognostic value and to create a clinical IIH database. The clinical database will answer questions about patient characteristics at baseline and during follow-up, identify predictors of outcome, and help create a standardized programme for follow-up and

NCT ID: NCT03304314 Recruiting - Pseudotumor Cerebri Clinical Trials

Multifocal Chromatic Pupilloperimetry in Patients With Pseudotumor Cerebri and Healthy Subjects.

Start date: November 3, 2017
Phase: N/A
Study type: Interventional

PTC(Pseudotumor cerebri) patients may develop increased Intracranial pressure (ICP) that can produces increased pressure around the distal optic nerve,which is likely followed by venule compression, ischemia, and loss of visual function.Vision loss in PTC is most commonly characterized by standard automated perimetry to measure peripheral visual field sensitivity. Pupillometry is a promising approach for functional assessment in PTC because it is noninvasive, objective, performed quickly with minimal patient cooperation needed. The feasibility of using chromatic multifocal pupillometry for assesment of PTC will be examined.