Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.

Recruiting now · Not applicable

Conditions studied: Pseudotumor Cerebri, Cerebrospinal Fluid, Transverse Sinuses

In brief

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

Key facts

Study ID

NCT05050864

Run by

Fondation Ophtalmologique Adolphe de Rothschild

People needed

276

Starts

2022-03-02

Expected to finish

2026-12-07

Last updated by the study team

2026-01-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient aged 18 or over
• HTICi proven greater than 25cm of water
• Presence of papillary edema (grade> 0 on the Frisen scale)
• Stenosis of at least one transverse sinus on MRI
• Failure of medical treatment and surgical / interventional indication defined by the medical team taking care of the patient
• Consent to participate in the study

You may not qualify if…

• Fulminant HTICi
• Contraindication to antiplatelet aggregation
• Contraindication to one or the other of the interventions under study
• Pregnant or breastfeeding woman

Where it is running

• Fondation A De Rothschild — Paris, Paris, France (enrolling)

Full record on ClinicalTrials.gov

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