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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Mr
Darren
Barton
IIHIntervention@trials.bham.ac.uk
None
-
IIH Intervention Trial Office
IIHIntervention@trials.bham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Idiopathic intracranial hypertension
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Idiopathic intracranial hypertension (IIH) is a neurological condition characterised by increased pressure inside the skull, called intracranial pressure (ICP). It is more common in women of reproductive age with obesity. Common symptoms of IIH include headaches, blurred vision and ringing in the ears. If left untreated, the disorder may cause blindness. The majority of patients with IIH are managed with weight loss and medications. Fewer than 10% of patients develop progressive visual loss and require urgent intervention to reduce ICP and preserve vision. This trial will compare the two most common interventions performed in the UK and evaluate their clinical and cost-effectiveness. The first is called cerebrospinal fluid (CSF) shunting and involves a procedure where a thin tube called a shunt is implanted in the body to drain brain fluid. The second is called dural venous sinus stenting (DVSS) and involves a procedure where a metallic mesh tube called a stent is implanted inside a brain blood vessel. Both procedures can preserve vision, but there is no strong evidence to support one over the other. Participants will have the same chance to be treated with CSF shunting or DVSS. The aim of the trial is to know which intervention is the most effective to save the vision and the most cost-effective.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
Current key exclusion criteria as of 31/03/2026:
1. Presence of current venous sinus thrombosis on diagnostic brain imaging by either MRI, MRV or CTV2. Previous surgery for IIH including, optic nerve sheath fenestration, CSF shunting procedures, sub-temporal decompression and DVSS.3. Previous bariatric surgery within the last 3 months4. Patients with a past ophthalmic history, except refraction error, affecting the eligible eyes (study eyes) that could affect the vision.5. Patient is, at the time of signing the informed consent, a user of recreational or illicit drugs (including marijuana) or has had a recent history (within the last year) of drug or alcohol abuse or dependence, in the opinion of the investigator.6. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study.7. Have participated in any other interventional study within 30 days prior to the screening visit (of note participation in the IIH Life database or other observational studies will not prevent enrolment to this study).8. Previous randomisation for treatment in the present study.9. Pregnant.10. Absolute or serious contraindication to standard anti-thrombotic regimen peri and post stenting.11. Secondary causes of raised intracranial pressure1. (Refer to protocol appendix 3 for additional information.)12. History of significant documented iodine-based contrast allergy.13. History of documented allergy to nitinol or nickel.14. Absolute or serious contraindication for general anaesthesia.15. Previous diagnosis of a hypercoagulable state (Factor V Leiden, Protein C or S deficiency, Anticardiolipin antibodies, Lupus anticoagulant, B2-glycoprotein-1 antibodies, or Hyperhomocysteinaemia).16. Currently requiring full anticoagulation for other medical reasons, such as atrial fibrillation, artificial valves, deep vein thrombosis or pulmonary embolism.17. Documented prior non-traumatic intracranial haemorrhage.18. History of deep vein thrombosis or pulmonary embolism (within the last 24 months).19. History of severe carotid atherosclerotic disease.20. History of heart failure, dilated cardiomyopathy or congenital heart disease, etc. that are assessed as at high thrombotic risk.
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Previous key exclusion criteria:
List of principal criteria:1. Presence of current venous sinus thrombosis on diagnostic brain imaging by either Magnetic Resonance Imaging (MRI), Magnetic Resonance Venography (MRV) or Computed Tomography Venography (CTV)2. A completely normal CTV (or MRV) with clear visualisation of the whole sinus with no evidence of stenosis(es)3. Previous surgery for IIH including, optic nerve sheath fenestration, CSF shunting procedures, sub-temporal decompression and DVSS.4. Previous bariatric surgery within the last 3 months5. Patients with a past ophthalmic history affecting the eligible eye(s) that could affect the vision (e.g. prior optic atrophy)6. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study7. Have participated in any other interventional study within 1 month prior to the screening visit (of note participation in the IIH Life database or other observational studies will not prevent enrolment in this study)8. Previous randomisation for treatment in the present study9. Pregnant10. Absolute or serious contraindication to standard anti-thrombotic regimen peri- and post-stenting11. Other secondary causes of raised intracranial pressure, including: haematological (e.g. moderate to severe anaemia); causes of venous obstruction (e.g. cerebral venous sinus thrombosis); medications (e.g. quinolones); systemic disorders (e.g. chronic kidney disease); endocrine (e.g. Addison’s disease); and syndromic (See Protocol Appendix 3 for a full list)12. Absolute or serious contraindication for general anaesthesia
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.
None
-
IIH Intervention Trial Office
IIHIntervention@trials.bham.ac.uk
Mr
Darren
Barton
IIHIntervention@trials.bham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Birmingham and funded by National Institute for Health and Care Research.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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