Idiopathic intracranial hypertension Nervous System Diseases
Conditions
Interventions
IIH Provoke is a prospective, randomised, double-blind, placebo-controlled two-way crossover physiology study. Up to 24 patients with idiopathic intracranial hypertension (IIH) will undergo headache p
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 60 years old 2. Previous diagnosis of idiopathic intracranial hypertension (IIH) 3. Able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Aged less than 18 or older than 60 years old 2. Optic nerve elevation exclusively due to pseudopapilloedema 3. Previous migraine history prior to the diagnosis of IIH (or non-IIH headache) > 1 day per month 4. Pregnant or trying to conceive 5. Significant co-morbidity; such that in the opinion of the investigator it would not be in the participant’s best interest to participate in the trial 6. Known cardiovascular or cerebrovascular disease 7. Medication overuse 8. Inability to comply with study schedule or follow-up 9. Currently using Glucagon-like peptide-1 receptor (GLP-1R) agonist or Dipeptidyl-peptidase 4 (DPP-4) inhibitor 10. Contra-indications to undergoing a surgical procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following measures were assessed after a single visit: 1. Incidence of provoked headache akin to the participant's typical IIH headache measured using a Headache assessment tool 2. Change in intracranial pressure (ICP) during a headache attack determined using physiological measurement 3. Headache physiological response over the 24 hours post-dose measured using a Headache assessment tool | — |
Secondary
| Measure | Time frame |
|---|---|
| The following measures were assessed after a single visit: 1. Change in headache features measured using a Headache assessment tool and diary 2. Dynamic changes in cerebrovascular physiology and headache biomarkers determined using physiological measurement | — |
Countries
England, United Kingdom
Outcome results
None listed