Research and Clinical Trials

 

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.

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

 

IIH Research in Birmingham (UK)

The 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.'


 

Clinical Trials that you can take part in!  

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
  The IIH:WT Trial 

This trial is no longer recruiting IIH Patients. 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. 

The 66th and final patient was recruited to the IIH WT in May 2017. 5 months ahead of schedule and 2 above target. The primary outcome will be reached in May 2018 with long term follow up continuing until 2022. Updates will be posted here.


 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. The Birmingham team look forward to getting a paper submitted for publication by the end of the year. Updates will be posted here.


 

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 


Breaking News! New GLP-1 drug found to lower brain pressure! 

https://m.medicalxpress.com/news/2017-08-scientists-common-obesity-diabetes-drug.html


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

http://adc.bmj.com/content/early/2017/03/28/archdischild-2016-312238

Evolving Evidence in adult IIH: Pathophysiology and management


http://jnnp.bmj.com/content/early/2016/02/17/jnnp-2015-311302.full

Chronic Fatigue Syndrome & IIH

What do lumbar puncture and jugular venoplasty say about a connection between chronic fatigue syndrome and idiopathic intracranial hypertension? http://www.ejmint.org/original-article/1443000223

Lumbar puncture, chronic fatigue syndrome and idiopathic intracranial hypertension: a cross-sectional study http://shr.sagepub.com/content/4/12/2042533313507920.full

IIH & Cognitive Function

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

. http://bmjopen.bmj.com/content/4/4/e004376.full


IIH and Shunt/Stent Research

 Shunts

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.http://www.thewaltoncentre.nhs.uk/223/hydrocephalus-research.html

Stents

http://clinicaltrials.gov/ct2/show/study/NCT01407809?term=Pseudotumor+Cerebri&rank=5

 

http://weillcornellbrainandspine.org/in-the-news/clinical-trial-tests-new-approach-idiopathic-intracranial-hypertension-pseudotumor

 

New study published March 2014 http://www.news-medical.net/news/20130313/New-procedure-to-treat-pseudotumor-cerebri.aspx

http://onlinelibrary.wiley.com/doi/10.1177/00912700122010195/abstract

  


NASA

Vision Impairment and Intracranial Pressure (VIIP) - 05.13.15 
 http://www.nasa.gov/mission_pages/station/research/experiments/1038.html

Investigates Techniques for Measuring Intracranial Pressure - https://www.nasa.gov/content/it-s-all-in-your-head-nasa-investigates-techniques-for-measuring-intracranial-pressure-u

NASA’s Visual Impairment & Intracranial Pressure Risk: Utilizing the ISS for Risk Reduction - http://www.astronautical.org/sites/default/files/attachment/Otto_0.pdf