IIH PROVOKE V1.0
Research type
Research Study
Full title
Mechanisms driving headache in Idiopathic Intracranial Hypertension, a human physiology study
IRAS ID
307968
Contact name
Alexandra Sinclair
Contact email
Sponsor organisation
University of Birmingham
ISRCTN Number
ISRCTN13251508
Clinicaltrials.gov Identifier
ERN, ERN_21-0593
Duration of Study in the UK
3 years, 3 months, 31 days
Research summary
The predominant issue in patients with idiopathic intracranial hypertension (IIH) is headache. There are currently no licensed treatments for IIH headache and we don't currently understand what causes it.
In the IIH Provoke study we will use detailed physiological assessments in people with IIH to help understand IIH headaches and hopefully be able to find new drug targets for this.
It will be important to understand what is actually happening to the brain pressure and the brain blood flow during headaches.We will explore in detail the role of a pain chemical called calcitonin gene-related peptide. We will assess if this product will cause typical IIH headaches.
In this study we will use special monitors (intracranial pressure monitors) and brain imaging (ultrasound and near-infrared spectroscopy).
We also wish to explore another medicine called glucagon-like peptide-1 receptor agonist. The reason for this is that our previous work has shown that it can reduce brain pressure.
Using this agent to lower brain pressure we will evaluate if this changes headache in IIH.Another interesting area of research is how does doing exercise affect headache. Therefore, we will also investigate the impact of exercise, straining and sleep on brain pressure, headache and blood flow in IIH.
This research could have direct relevance on patient care as this work will provide new insights into headache causes in raised brain pressure and could help guide future treatment.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
22/NE/0081
Date of REC Opinion
16 May 2022
REC opinion
Favourable Opinion