Reviewed by Michael Gill, B. Sc.
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Phase-Based Progress Estimates
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Effectiveness
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Safety

Neurointerventionalfor Idiopathic Intracranial Hypertension

18+
All Sexes
Increased Intracranial Hypertension (IIH), also known as Pseudotumor Cerebri, is defined by increased cerebral spinal fluid (CSF) pressure in the absence of intracranial, metabolic, toxic or hormonal causes of intracranial hypertension. It is characterized by headaches, tinnitus and visual loss, due to optic atrophy, in 50% of cases. Surgical treatments, such as CSF shunt placement and optic nerve sheath fenestration (ONSF), are indicated in case of failure or non-compliance (owing to side effects) of medical treatments (that mainly includes weight loss and drugs, such as Carbonic Anhydrase Inhibitors). However, these surgical treatments are limited by relative high complications and recurrence rate. Indeed, improvement in visual function after ONSF is often transient and the risk of complications, including visual loss, pupillary dysfunction, and vascular complications is up to 40%. With no better treatment option, intraventricular or lumbar shunt placement has become the traditional treatment for medically refractory IIH, despite poor results. Indeed, series of patients with IIH treated with shunt replacement report a complications rate (shunt occlusion, disconnection, infection or intracranial hematoma formation) around 50% and a failure rate up to 64% within 6 months. As a consequence, shunt revision is often required and efficacy of the technique to control the disease is questionable. The role of intracranial transverse sinus stenosis in IIH has recently gained a particular interest. Despite the fact that transverse sinus stenosis in IIH may be due to increased intracranial pressure, some authors believe that the rise in intracranial pressure and its effect are worsened by the secondary appearance of the venous sinus stenosis. To date, very few complications have been reported in IIH patients with venous sinus stent placement.
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The Ottawa Hospital Civic Campus
7 Intracranial Hypertension Clinical Trials Near Me
Top Hospitals for Intracranial Hypertension Clinical Trials
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University of Minnesota
Minneapolis
1Active Trials
3All Time Trials for Intracranial Hypertension
2010First Intracranial Hypertension Trial
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Cleveland Clinic Florida
Weston
1Active Trials
1All Time Trials for Intracranial Hypertension
2017First Intracranial Hypertension Trial
Top Cities for Intracranial Hypertension Clinical Trials
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Minneapolis
1Active Trials
University of MinnesotaTop Active Site
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Weston
1Active Trials
Cleveland Clinic FloridaTop Active Site
Intracranial Hypertension Clinical Trials by Phase of Trial
Phase 2 Intracranial Hypertension Clinical Trials
1Active Intracranial Hypertension Clinical Trials
1Number of Unique Treatments
1Number of Active Locations
Intracranial Hypertension Clinical Trials by Age Group
Top Treatments for Intracranial Hypertension Clinical Trials
Treatment Name
Active Intracranial Hypertension Clinical Trials
All Time Trials for Intracranial Hypertension
First Recorded Intracranial Hypertension Trial
Video ophthalmoscope
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1
2019
Study Arm
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2017
Venous sinus stenting (Serenity River)
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1
2018
Intensive Treatment
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2018
MRI structural brain imaging
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2017

What are Intracranial Hypertension Clinical Trials?

Intracranial hypertension (IH) is the increase of pressure around the brain and is classified into three types:

  • Acute IH: Pressure build-up around the brain caused by stroke, severe head injury, or brain abscess.
  • Chronic IH: A long-term pressure build-up caused by a brain tumor, a chronic subdural hematoma, infection, hydrocephalus, abnormal blood vessels, or venous sinus thrombosis.

When the underlying cause of chronic IH is unknown, it is called idiopathic IH and is seen mainly in women ages 20 – 30. Possible reasons for IIH include obesity, hormonal disbalance, reaction to medicine, chronic kidney disease, and lupus.

Symptoms of IH include a constant throbbing headache that can vary in intensity, temporary loss of eyesight, tinnitus, nausea, lethargy, and irritability. If left untreated, IH can cause permanent loss of vision.

Why Is Intracranial Hypertension Being Studied In Clinical Trials?

Estimates suggest 2 in 100,000 people have idiopathic intracranial hypertension (IIH), with women being 20 times more likely to be affected than men. The reasons for this and the cause are still unknown.

Clinical trials can offer insight into the internal mechanism leading to excess pressure around the brain. Researchers have proposed a number of theories, such as excess cerebrospinal fluid, increased blood volume, or obstructions in the veins that drain the blood from around the brain. However, further investigation is necessary to understand the cause and determine the risk factors, which can lead to a cure for this condition.

How Does Intracranial Hypertension Treatment Work?

Intracranial hypertension (IH) is diagnosed after several examinations, including, but not limited to, CT scans, MRIs, MR venograms, contrast-enhanced MRV, and lumbar punctures.

Lumbar punctures are often done to reduce the fluid around the brain and provide immediate pressure relief. While it can be done repeatedly, it can lead to infection and is uncomfortable for patients.

As there is no definite cure for IH, management options focus on decreasing the symptoms, particularly vision loss. Medications such as painkillers, acetazolamide (to decrease the amount of cerebrospinal fluid the body makes), and furosemide (a diuretic to decrease the fluid in the body) are prescribed.

Two surgical options are currently available to reduce the pressure, optic nerve sheath decompression and shunting. Though riskier, these are the best options for patients not responding to medications with severe symptoms.

What Are Some of the Breakthrough Clinical Trials Involving Intracranial Hypertension?

2016: This trial was the first to study the effectiveness and safety of AZD4017, a 11β-HSD1 inhibitor, to treat intracranial hypertension by reducing the pressure. Thirty-one female patients aged 18 – 55 were divided into a treatment and placebo group. Then cerebrospinal fluid (CSF) was measured over 12 weeks. Findings showed a decrease in CSF.

2018: A clinical trial aimed to determine the primary clinical and lab factors of patients with untreated idiopathic intracranial hypertension (IIH). One of the most extensive studies done to collect data on IIH observed and tested 165 patients, and one of its findings showed IIH was mainly in obese young women.

About The Author

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: October 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

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