BridgeMD
Compares treatment options for IIH - Idiopathic Intracranial Hypertension
Official title IIH Intervention: A Clinical Trial Comparing 2 Treatments (Shunts and Stents) Evaluation Of Clinical Effectiveness And Cost Effectiveness
ClinicalTrials.gov ID: NCT07440277
What this study is testing
- What it's testing
- Background and study aims 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 63
You may be able to join if
- Diagnosis of IIH by the IIH consensus guidelines with papilloedema and at risk of visual loss.
- Presence of papilloedema (Frisén grade ≥ 3) in at least one eye
- Age 18 to \< 64 years at the time of consent.
- Patients must be suitable for and willing to proceed with both CSF shunting (VP or Lumboperitoneal shunts only) and DVSS.
- Able to provide written informed consent.
You likely can't join if
- Presence of current venous sinus thrombosis on diagnostic brain imaging by either MRI, MRV or CTV
- Previous surgery for IIH including, optic nerve sheath fenestration, CSF shunting procedures, sub-temporal decompression and DVSS.
- Previous bariatric surgery within the last 3 months
- Patients with a past ophthalmic history, except refraction error, affecting the eligible eyes (study eyes) that could affect the vision.
- 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...
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of...
See the full eligibility criteria
- Diagnosis of IIH by the IIH consensus guidelines with papilloedema and at risk of visual loss.
- Presence of papilloedema (Frisén grade ≥ 3) in at least one eye
- Age 18 to \< 64 years at the time of consent.
- Patients must be suitable for and willing to proceed with both CSF shunting (VP or Lumboperitoneal shunts only) and DVSS.
- Able to provide written informed consent.
- Presence of current venous sinus thrombosis on diagnostic brain imaging by either MRI, MRV or CTV
- Previous surgery for IIH including, optic nerve sheath fenestration, CSF shunting procedures, sub-temporal decompression and DVSS.
- Previous bariatric surgery within the last 3 months
- Patients with a past ophthalmic history, except refraction error, affecting the eligible eyes (study eyes) that could affect the vision.
- 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...
- 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...
- Have participated in any other treatment 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).
- Previous randomisation for treatment in the present study.
- Pregnant.
- Absolute or serious contraindication to standard anti-thrombotic regimen peri and post stenting.
- Secondary causes of raised intracranial pressure. (Refer to Protocol appendix 3 for additional information.)
- History of significant documented iodine-based contrast allergy.
- History of documented allergy to nitinol or nickel.
- Absolute or serious contraindication for general anaesthesia.
- Previous diagnosis of a hypercoagulable state (Factor V Leiden, Protein C or S deficiency, Anticardiolipin antibodies, Lupus anticoagulant, B2-glycoprotein-1 antibodies, or Hyperhomocysteinaemia).
- Currently requiring full anticoagulation for other medical reasons, such as atrial fibrillation, artificial valves, deep vein thrombosis or pulmonary embolism.
- Documented prior non-traumatic intracranial haemorrhage.
- History of deep vein thrombosis or pulmonary embolism (within the last 24 months).
- History of severe carotid atherosclerotic disease.
- History of heart failure, dilated cardiomyopathy or congenital heart disease, etc. that are assessed as at high thrombotic risk.
- Presence of intracranial vascular malformation considered clinically symptomatic (current or within 24 months).
- Anatomical anomaly of the venous sinus which would prevent safe catheterisation and stenting (e.g. multi-channel sinus).
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, United Kingdom
- Bristol, United Kingdom
- Cambridge, United Kingdom
- Cardiff, United Kingdom
- Edinburgh, United Kingdom
- Glasgow, United Kingdom
- Hull, United Kingdom
- Leeds, United Kingdom
- London, United Kingdom
- Newcastle, United Kingdom
- Nottingham, United Kingdom
- Southampton, United Kingdom
- Sunderland, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 63 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, United Kingdom; Bristol, United Kingdom; Cambridge, United Kingdom; Cardiff, United Kingdom; Edinburgh, United Kingdom; Glasgow, United Kingdom and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.