CompletedInterventional

IIH Provoke: headache mechanisms in idiopathic intracranial hypertension

Idiopathic intracranial hypertension (IIH) is a condition where high pressure builds up around the brain. It mainly affects younger women and causes severe, long-term headaches that can be difficult to treat. Researchers at the University of Birmingham are investigating what causes these headaches. Participants in the study will have a tiny pressure monitor placed under the scalp to measure brain pressure directly, avoiding the need for repeated lumbar punctures. During the study, doctors will give a natural body chemical called CGRP to see if it triggers typical headache symptoms while they track pressure and blood flow. Participants will also receive a medication that may help lower brain pressure. The goal of this study is to uncover the biological triggers of IIH headaches. This information will help doctors find new and more effective treatments for people living with this painful condition.

At a glance

Status

Completed

Sponsor

University of Birmingham

Enrolment target

Start

13 Feb 2023

Estimated completion

31 May 2025

Idiopathic intracranial hypertension

What is this study about?

Idiopathic intracranial hypertension (IIH) is a condition where fluid pressure builds up around the brain without an obvious cause. It most commonly affects women and can lead to severe, disabling headaches and sight problems. At the moment, there are very few treatments designed specifically to stop IIH headaches, mainly because doctors do not yet fully understand how the raised pressure triggers the pain.

This study, called IIH Provoke, aims to uncover the exact biology behind these headaches. Researchers believe a natural pain-signalling chemical in the body, known as CGRP, plays a major role. They also want to test whether a type of medication called a GLP-1 receptor agonist can safely bring brain pressure down and relieve pain once a headache starts. Additionally, the team will look at how everyday activities, such as sleep, gentle exercise, and straining, influence pressure inside the head.

By taking part, participants provide crucial clues about how brain pressure and nerve pain interact. The knowledge gained from this trial could lead to new, targeted medicines that prevent or treat debilitating headaches, greatly improving quality of life for people with IIH in the future.

Key takeaways

The study explores the biological causes of headaches in idiopathic intracranial hypertension (IIH).
Participants will have a tiny pressure monitor placed under the scalp to measure brain pressure without needle taps.
Researchers will test whether a natural chemical triggers headaches and whether a specific medicine can relieve them.
Open to adults aged 18 to 60 with a confirmed diagnosis of IIH who meet the health criteria.
The trial takes place at the University of Birmingham and provides close specialist monitoring.

Who may be eligible?

You may be able to join this study if you are between 18 and 60 years old and have a confirmed diagnosis of idiopathic intracranial hypertension (IIH). You must also be able to understand the study details and give your informed consent.

You will not be able to take part if you had frequent migraines or other regular headaches (more than one day a month) before you were diagnosed with IIH. You will also be excluded if you are pregnant, planning to become pregnant, or have significant heart or blood vessel disease.

Finally, people who currently take certain medications, such as GLP-1 medicines or DPP-4 inhibitors (often used for diabetes or weight management), or those who overuse headache painkillers, cannot take part. Your study doctor will review your overall health to ensure that undergoing the small surgical procedure to fit the monitor is safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged between 18 and 60 years old.
I have been officially diagnosed with idiopathic intracranial hypertension (IIH).
I did not have regular migraines or frequent headaches before my IIH started.
I am not pregnant and not currently trying to conceive.
I am not taking GLP-1 or DPP-4 medications for diabetes or weight loss.
I am generally well enough to have a minor surgical procedure under anaesthetic.

Answer every question to see your result.

What does participation involve?

Taking part involves several visits to the hospital in Birmingham. Where suitable, a specialist surgeon will fit a small, wireless brain pressure monitor under your scalp during a short procedure. This monitor sends readings directly to the medical team, removing the need for frequent lumbar punctures (spinal taps) to check your pressure.

During your research visits, doctors will give you a dose of CGRP through a drip to see if it brings on your typical headache pain. While this happens, the team will closely monitor your brain pressure and blood flow. You will then receive an injection of a medication designed to lower brain pressure and ease the headache, or a dummy treatment (placebo) to compare the results.

You will also be monitored during routine activities like light exercise, straining, and sleeping. If you experience a spontaneous headache outside planned tests, you can attend the hospital for quick medical care and assessment. The study runs over several visits between 2021 and 2025, and your study team will give you a clear schedule before you agree to join.

Potential risks and benefits

Taking part offers several possible benefits, including very close monitoring of your condition by IIH specialists and access to quick treatment if you have a headache. The implanted monitor also allows doctors to check your pressure without repeated lumbar punctures. The study drug may help lower your brain pressure and support weight loss. However, there are risks to consider. The surgery to insert the monitor carries small risks of bleeding, infection, seizures, or device problems that might require removal. The medications can cause temporary side effects such as nausea, skin flushing, a racing heart, or a feeling of warmth, and very rarely, low blood pressure or inflammation of the pancreas. Joining is completely voluntary, and you are free to leave the trial at any time without affecting your normal NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals Birmingham NHS Foundation Trust
City only
Birmingham, England

Common questions

Will having a headache triggered on purpose be dangerous?

The researchers use a controlled dose of CGRP in a safe hospital setting. The team is on hand immediately to treat your headache and monitor your brain pressure throughout.

What is the brain pressure monitor and will it hurt?

It is a tiny wireless sensor placed just under the scalp during a short surgical procedure under anaesthetic. Once healed, it allows doctors to read your pressure painlessly from the outside.

Do I have to pay to take part?

No, taking part in NHS-linked clinical research is free. You may also be offered help with travel expenses to attend your study appointments in Birmingham.

Can I leave the study if I change my mind?

Yes. You can withdraw from the study at any point without giving a reason. Your standard medical treatment and relationship with your doctors will not be affected.

Will taking part cure my IIH?

No, this study is designed to help researchers understand how headaches work in IIH rather than to provide a permanent cure, though the treatments tested may temporarily ease symptoms.

How to find out more

Andreas Yiangou

a.yiangou@bham.ac.uk +44 (0)1213712000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.