Research and Clinical Trials

Medical Research

Medical research can be divided into two general categories: the evaluation of new treatments for both safety and efficacy in what are termed clinical trials, and all other research that contributes to the development of new treatments.

Clinical research is research that directly involves a particular person or group of people, or that uses materials from humans, such as their behavior or samples of their tissue.

clinical trial is one type of clinical research that follows a pre-defined plan or protocol. By taking part in clinical trials, participants can not only play a more active role in their own health care, but they can also access new treatments and help others by contributing to medical research.

Research and clinical trials are an everyday part of the work done in the NHS. Visit the NHS webpage here that explains about medical research and taking part in clinical trials.

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NHS Choices give a very good explanation of clinical trials by a doctor on Youtube here


NEW Report into the effects of Lockdown on those people living with IIH.  In march 2020 the UK and world experienced an unprecedented event of a global pandemic Covid-19. In the UK lockdown started on March the 23rd and IIH UK was keen to capture the impact on the lives of people with IIH. A great response was received to the IIH UK short survey about lockdown. 121 people responded to the survey which ran from 24/05/2020 to 24/06/2020. 120/121 who responded added additional comments to explain their response.  You can read the Life in Lockdown Report HERE

 Idiopathic Intracranial HypertensionRead about our involvement with the James Lind Alliance here


Idiopathic intracranial hypertension: consensus guidelines on management :

The IIH Guidelines were written in association with:
Lead by Dr Sinclair and Miss Mollan 
A multidisciplinary team from the UK
Association of British Neurologists 
Royal college of Ophthalmologists 
Society for British Neurological Surgeons 
British Association for the Study of Headache 
Key leaders in the field from Europe and US

                                                                            IIH UK Research

Characterising the patient experience of diagnostic lumbar puncture in idiopathic intracranial hypertension: a cross-sectional online survey. This patient initiated research aims to guide future clinical practice of Lumbar Puncture.

Illuminating the Patient experience of Lumbar Puncture: A survey carried out by IIH UK, which exposed the toll on patients of undergoing repeated Lumbar Puncture, has spurred a collaborative research project and paved the way for improved clinical management. Illuminating the Patient Experience of LP

(NEW RESEARCH 6/4/18) Participation request for research investigating the specific barriers to weight loss and exercise in idiopathic intracranial hypertension

IIH UK Research Reps Amanda Denton (Plymouth University) and Krystal Hemmings (The University of Derby) would like to invite you to take part in a research study, which is investigating the correlations between weight and physical activity levels with headaches and quality of life in individuals with IIH, as well as the specific barriers to weight loss and exercise.

Taking part will involve taking measurements of your weight (with minimal or no clothing on) and height (not wearing footwear) first thing in the morning and then answering an online questionnaire which should take 40 minutes to one hour of your time.
A greater understanding of the relationship between these specific factors and an exploration of the barriers to weight loss and exercise in individuals with IIH could guide clinical treatment and advice and ultimately lead to the development of interventions.

If you would like to take part, please click on the link below which will provide you with more information.

This research survey is now closed.  Updates will be placed here. 


IIH Research in Birmingham (UK)

IIH LifeThe IIH Life Registry has been developed by Dr Alexandra Sinclair MBChB, MRCP, PhD - NIHR Clinician Scientist and Honorary Consultant Neurologist, Neurotrauma and Neurodegeneration at School of Clinical and Experimental Medicine College of Medical and Dental Sciences University of Birmingham.

Have you recently been diagnosed with IIH? Would you like to take part in UK IIH research?

The IIH Life Registry will soon be rolled out to neurological hospitals across the UK, please watch this page for updates. 
What does this mean for you and what information will it capture?

The first phase of the registry was rolled out in Birmingham and Moorfields London for patients newly diagnosed with IIH. The data and feedback will be assessed to ensure that the database is running as expected and provide an opportunity to add or remove questions. It will then be rolled out to three hospitals every three months. When it is fully up and running, forty UK hospitals will be participating. If you would like to take part, please mention this to your Neurologist/ Neuro Ophthalmologist.

The database comprises of two parts – one for Neurologist/Neuro Ophthalmologist entries and the other for patient input. The medical professionals will be entering data which will include: visual test results, lumbar puncture opening pressures, medication (including dose), height, weight etc. The patient will be asked about their pain levels and asked to complete an annual Quality of Life survey.

What are the objectives?

Dr Alex Sinclair stated that she hoped that the registry would be able to indicate the optimal treatment for:

1. Sight Preservation

2. Managing Headaches

3. Improving IIH Sufferers’ Quality of Life.

Dr Sinclair and her team will be looking to see which treatments have better outcomes and will look at how different hospitals treat IIH. The Team anticipate that the data will help develop national evidence based standard for IIH management and provide a standard for care across the country. The IIH Life Registry will improve understanding of IIH as very little has been published on long-term disease outcomes and disability in IIH and will improve patient care and safety. It will identify patients at risk of poor outcomes and counsel patients and guide future research design. By involving patients the research will ensure patients’ views and perception of care, play a central role in future IIH management.

Dr Sinclair says: 'I look forward to working with you all to improve care for IIH patients.'


 Link - IIH:Pressure This trial has completed phase 2. Update coming soon. 
IIH Pressure

IIH Pressure Head Image IIH:Pressure 
The IIH Pressure trial is beginning to recruit IIH Patients.  This trial aims to use a new method of pressure monitoring to measure the brain pressure continuously without lumbar puncture and to to test if a new drug (Exanatide) can change brain pressure.  It is a randomised double blind study so those who are accepted onto the trial will be put into one of two groups which will be decided at random.  This is the first study of it's kind and we are very excited to see the results.
IIH Pressure - Diagram


Families with IIH  IIH UK are interested in promoting research into families with IIH. The Birmingham IIH research team are looking for families where more than one person has IIH. Please contact us if you are interested in taking part in this study. It’s a very exciting development as there is so little IIH research and the study of families could lead to important advances in understanding IIH and thereby helping improve treatment and care. Please email This email address is being protected from spambots. You need JavaScript enabled to view it.  if you are interested in taking part.



The IIH:WT is a randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of Idiopathic Intracranial Hypertension. Click the link to find out more

Link - The IIH:WT Trial 

 A number of healthy controls (people without IIH) are still required so please do get in touch if you DO NOT have IIH and would like to take part or require more information.

You can read more about this here

The 66th and final patient was recruited to the IIH WT in May 2017. 5 months ahead of schedule and 2 above target. Followups for this trial will continue for 5 years.  Updates will be posted here.

The IIH Drug Trial results have now been published!
Markey M, Mitchell J, Botfield H, Ottridge RS, Matthews T, Krishnan A, Woolley R, Westgate C, Yiangou A, Alimajstorovic Z, Shah P, Rick C, Ives N, Taylor A, C Gilligan L, Jenkinson C, Arlt W, Scotton W, Fairclough R,
Singhal R Stewart P, Tomlinson J, Lavery G, Mollan S, Sinclair A. 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibition in Idiopathic Intracranial Hypertension: A Double-Blind Randomized Controlled Trial Brain Communications, fcz050,

The IIH drug trial IIH:DT is a randomized controlled trial of drug AZD4017 vs placebo for treatment of IIH. The trial recruited at Queen Elizabeth hospital, Birmingham. Walton Centre, Liverpool and the Southern General Hospital, Glasgow. Click the link to find out more

IIH:DT Trial


This trial is no longer recruiting.

The IIH:DT finished follow up in December 2016 and the Birmingham central team spent much of February and March with data querying and cleaning. Analysis has now been started and we hope that work on the main results paper will start very soon. We will be informed of the results when they are published online. 


Non Invasive ICP

In Southampton they are running a trail for IH, testing a non invasive ICP monitoring device and need health people to join them. Barbara Mason one of our member whose  daughter has IIH decided to take part.

Barbara says “The team where very nice and made me feel relaxed. I had to complete a basic questionnaire about my health, ears, nose and throat, answer some simple cognitive questions then after they had attached pad to take my heart reading and bits like this they put the probe into my ear which takes the ICP reading. They played different sounds and it was a simple as that in each ear. Once the trial is over I will get a copy of my pressure reading.

To find out more visit the website or please contact Gabriella at Southampton on 023 8120 3713


 IIH UK Member Caroline Billings spoke about her experience of taking part in a clinical trial and why she had signed up to the Birmingham IIH Drug Trial. Read her story here 

 IIH UK Research Papers

Characterising the patient experience of diagnostic lumbar puncture in idiopathic intracranial hypertension: a cross-sectional online survey. This patient initiated research aims to guide future clinical practice of Lumbar Puncture.

Illuminating the patient experience of lumbar puncture

Paediatric Research

Pseudotumor cerebri syndrome in childhood: incidence, clinical profile and risk factors in a national prospective population-based cohort study

Other Research Papers

NEW! Exploring The Current Management Idiopathic Intracranial Hypertension, And Understanding The Role Of Dural Venous Sinus Stenting

Association Between Idiopathic Intracranial Hypertension and Risk of Cardiovascular Diseases in Women in the United Kingdom

Advances in the understanding of headache in idiopathic intracranial hypertension

Differing presenting features of idiopathic intracranial hypertension in the UK and US

A unique androgen excess signature in idiopathic intracranial hypertension is linked to cerebrospinal fluid dynamics.   An important study in IIH where they demonstrate a unique androgen excess phenotype in IIH, hopefully this will lead to better treatments in the future.

Therapeutic lumbar puncture for headache in idiopathic intracranial hypertension: Minimal gain, is it worth the pain?

Topiramate is more effective than acetazolamide at lowering intracranial pressure

NEW! Evaluating the Fat Distribution in Idiopathic Intracranial Hypertension Using Dual-Energy X-ray Absorptiometry Scanning

GLP-1 drug found to lower brain pressure!

Idiopathic Intracranial Hypertension, Hormones and 11ß-hydroxysteroid dehydrogenases

Women with IIH have a distinct andro-metabolic signature compared to polycystic ovary syndrome and simple obesity.

Androgen excess is highly prevalent in women with IIH and is biochemically distinct from polycystic ovary syndromes

Dissecting the androgen excess phenotype of women with IIH

Idiopathic Intracranial Hypertenson VISION (venous intervention versus shunting in IIH for optic nerve disc swelling) trial: patient perspective questionnaire

Evolving Evidence in adult idiopathic intracranial hypertension: pathophysiology and management.

The Incidence of Blindness Due to Idiopathic Intracranial Hypertension in the UK:

Pseudotumor Cerebri syndrome (IIH) in Children: incidence, clinical profile and risk factors in a national prospective population-based cohort study.

Chronic Fatigue Syndrome & IIH: What do lumbar puncture and jugular venoplasty say about a connection between chronic fatigue syndrome and IIH?

Lumbar puncture, chronic fatigue syndrome and idiopathic intracranial hypertension: a cross-sectional study

IIH & Cognitive Function Cognitive function in idiopathic intracranial hypertension: a prospective case–control study

Low energy diet and intracranial pressure in women with idiopathic intracranial hypertension: prospective cohort study

Decrease of intracranial pressure weight with Digoxin in obesity

IIH and Shunt/Stent Research


The BASICS trial is on shunt infection and Investigation of host response in shunt infection. For this trial patients undergoing insertion of a new VP shunts will be invited to participate. Patients will be randomised to standard, antibiotic-impregnated or silver-impregnated shunts to investigate whether these new types of shunt reduce the infection rate. Also investigating new diagnostic tests for shunt infection, as well as assessing why certain patients are more prone to infection.


NEW: Exploring The Current Management Idiopathic Intracranial Hypertension, And Understanding The Role Of Dural Venous Sinus Stenting

Procedure to treat



Vision Impairment and Intracranial Pressure (VIIP) - 05.13.15

Investigates Techniques for Measuring Intracranial Pressure -

NASA’s Visual Impairment & Intracranial Pressure Risk: Utilizing the ISS for Risk Reduction



IIH UK is members of the following organisations.

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