An interventional study of CSF shunt and DVSS in IIH - Idiopathic Intracranial Hypertension, sponsored by University of Birmingham. Recruiting at 15 sites in United Kingdom. Open to participants aged 18 Years to 63 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by University of Birmingham · Not applicable, Interventional, and Treatment
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. Common symptoms of IIH include headaches, blurred vision and ringing in the ears. If left untreated, the disorder may cause blindness. The majority of patients with IIH are managed with weight loss and medications. Fewer than 10% of patients develop progressive visual loss and require urgent intervention to reduce ICP and preserve vision. This trial will compare the two most common interventions performed in the UK and evaluate their clinical and cost-effectiveness. The first is called cerebrospinal fluid (CSF) shunting and involves a procedure where a thin tube called a shunt is implanted in the body to drain brain fluid. The second is called dural venous sinus stenting (DVSS) and involves a procedure where a metallic mesh tube called a stent is implanted inside a brain blood vessel. Both procedures can preserve vision, but there is no strong evidence to support one over the other. Participants will have the same chance to be treated with CSF shunting or DVSS. The aim of the trial is to know which intervention is the most effective to save the vision and the most cost-effective.
Who can participate? Adults with a diagnosis of IIH at risk of permanent sight loss
What does the study involve? The trial will be conducted in NHS hospitals located in England, Wales and Scotland. Participants are randomly allocated to undergo cerebrospinal fluid (CSF) shunting or dural venous sinus stenting (DVSS). Afterwards the participants will be asked to attend 11 hospital appointments and one telephone appointment. This follow-up will take 2 years from start to finish. Participants will be closely monitored for any side effects and potential device failure, and for changes in vision, headaches and quality of life. The researchers will also collect health data from NHS Digital (the national custodian of NHS health and social care data).
What are the possible benefits and risks of participating? There are no direct benefits from taking part in the trial but the information gained from this trial may help improve treatment for adults with IIH in the future. Participants may be seen more often and/or feel more supported as a consequence of their involvement in the trial. As with any intervention, there are risks and complications, but there are no additional disadvantages or risks involved in taking part in this trial. Both CSF shunting and stenting are treatments for IIH (shunting is widely used internationally, and in some hospitals, stenting is used as part of the standard of care). Participants require an intervention to prevent sight loss. None of these treatments is experimental but at present, there is not enough information to determine which treatment is most suitable and provides the higher level of health benefits to the individual.
Where is the study run from? University of Birmingham (UK)
When is the study starting and how long is it expected to run for? The first site opened in July 2023, and the last patient last visit is expected in May 2028
Who is funding the study? National Institute for Health Research (NIHR, grant number: NIHR131211) (UK)
Who is the main contact? IIH Intervention Trial manager, IIHIntervention@trials.bham.ac.uk (UK)
53 studies on the registry are indexed under Pseudotumor Cerebri; 22 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 35 interventional studies indexed under Pseudotumor Cerebri.
Browse Pseudotumor Cerebri studies →University of Birmingham is the lead sponsor of 182 studies on the registry; 29 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cerebrospinal fluid shunt
Device: CSF shunt
Dural Venous Sinus Stenting
Device: DVSS
CSF shunt may be ventriculoperitoneal (VP) or lumboperitoneal (LP) at the discretion of the treating medical team.
Dural Venous Sinus Stent. Exact make and model of device not mandated by protocol.
Global thickness of the retinal nerve fibre layer (RNFL) over 6 months, as measured by OCT
Global thickness of the retinal nerve fibre layer (RNFL) over 6 months, as measured in micrometers by OCT
Time frame: 6 months
Global thickness of the retinal nerve fibre layer (RNFL)
Global thickness of the retinal nerve fibre layer (RNFL) measured in micrometers by OCT over 12 and 24 months
Time frame: 12 months, 24 months
Total retinal nerve fibre layer thickness
Total retinal thickness measured in micrometers by OCT
Time frame: 6, 12 and 24 months
Disc global volume
Disc global volume measured in micrometers cubed by OCT
Time frame: 6, 12 and 24 months
Disc central thickness
Disc central thickness measured by OCT (micrometers)
Time frame: 6, 12 and 24 months
Disc maximum height
Disc maximum height measured by OCT (micrometers)
Time frame: 6, 12 and 24 months
Macular ganglion cell layer volume
Macular ganglion cell layer volume as measured by OCT in micrometers cubed
Time frame: over 6, 12 and 24 months
Visual acuity
Visual acuity, measured by logarithm of the minimum angle or resolution (LogMAR) units. Visual acuity (VA) is measured on the logMAR scale by sight tests in clinic using Early treatment diabetic retinopathy study (ETDRS) charts at 4 meters. Values are taken for each eye separately, both uncorrected, and corrected with glasses or contact lenses, and can range from 0, which represents perfect vision i.e. 20/20 (values of-0.1 and -0.2 are also possible representing better than perfect vision), to +2 which represents near blindness i.e. 20/2000. Increases in logMAR represent deterioration in vision.
Time frame: Over 6, 12 and 24 months
Humphrey Visual Fields (HVF) Perimetric Mean Deviation (PMD)
Humphrey Visual Fields (HVF) 24-2 SITA standard visual field test measured by Perimetric Mean Deviation (PMD). Visual threshold is the intensity of stimulus seen 50% of the time at each location. Higher numbers mean the patient was able to see a more attenuated light, and thus has more sensitive vision at that location. The numerical total deviation map compares the patient's visual sensitivity to an average normal individual of the same age. It is useful to compare with age-matched normal thresholds as sensitivity normally decreases gradually with age. Positive values represent areas of the field where the patient can see dimmer stimuli than the average individual of that age. Negative values represent decreased sensitivity from normal. Reliability indices, including fixation losses, false positives, and false negatives are also included.
Time frame: Over 6, 12 and 24 months
Proportion of patients re-presenting to hospital within 30 days post-intervention
Proportion of patients re-presenting to hospital within 30 days post-intervention. Percentage
Time frame: 30 days
Proportion of patients being re-admitted to hospital within 30 days post-intervention.
Proportion of patients being re-admitted to hospital within 30 days post-intervention. Percentage
Time frame: 30 days
Proportion of major complication, defined as the incidence of complications graded between III and V or major anaesthesia problems (including complications from revision procedures) according to the Clavien-Dindo classification of surgical complications
Measured by the Clavien-Dindo classification of surgical complications. The Clavien-Dindo scale is a validated, 5-grade, ordinal scale used to grade surgical complications based on the therapeutic interventions required to manage them. It provides a standardised, objective method for reporting postoperative morbidity (grades I-IV) and mortality (grade V), with increasing severity based on the level of care, from minor bedside treatment to ICU-level support or death.
Time frame: over 6, 12 and 24 months
Proportion with minor complications, defined as Clavien-Dindo grade I-II during hospital stay.
Measured by the Clavien-Dindo scale; grade I-II. The Clavien-Dindo scale is a validated, 5-grade, ordinal scale used to grade surgical complications based on the therapeutic interventions required to manage them. It provides a standardized, objective method for reporting postoperative morbidity (grades I-IV) and mortality (grade V), with increasing severity based on the level of care, from minor bedside treatment to ICU-level support or death.
Time frame: Over 6, 12 and 24 months
Proportion of patients requiring revision in whom the revision intervention is the same as the primary intervention
Percentage
Time frame: over 6, 12 and 24 months
Proportion of patients requiring revision in whom the revision intervention crosses over to the alternative intervention
percentage
Time frame: over 6, 12 and 24 months
Time to first revision
measured in days from day of intervention to day of first revision
Time frame: measured in days over 6, 12 and 24 months
Number of revisions per patient
number
Time frame: over 6, 12 and 24 months
Proportion of patients with Adverse Events grade 3 or above measured by the CTCAE version 5.
CTCAE v5. In the CTCAE, symptoms are categorised by organ system, ranging from mild (Grade 1) to death (Grade 5)
Time frame: Over 6, 12 and 24 months
Monthly headache days
number of days per month with headache reported
Time frame: over 6, 12, and 24 months
Monthly moderate to severe headache days
Measured by number of headache days per month with a severity greater than or equal to 4. 0-10 scale where 0 is no headache and 10 is the worst imaginable headache. Scores between 4 and 10 will be considered moderate to severe.
Time frame: over 6, 12 and 24 months
Headache severity (numeric rating scale (NRS) 0-10)
Headache severity measured by (numeric rating scale (NRS) 0-10) where 0 is no headache and 10 is the worst headache
Time frame: over 6, 12 and 24 months
Moderate to severe headache severity (NRS greater than or equal to 4)
Headache severity measured by (numeric rating scale (NRS) 0-10) where 0 is no headache and 10 is the worst headache. Moderate to severe headache severity (NRS greater than or equal to 4)
Time frame: Over 6, 12 and 24 months
Monthly use of acute headache analgesics
number of days per month where analgesics are used to treat headaches as documented on the concomitant medication form and the headache diary.
Time frame: over 6, 12 and 24 months
Quality of Recovery 15 (QoR-15) measured at time of discharge
QoR 15 is a validated, 15-item patient-reported questionnaire used to measure the quality of recovery after surgery and anaesthesia, with a maximum score of 150 indicating excellent recovery.
Time frame: At time of discharge (usually within 7 days of intervention)
Satisfaction with intervention (5-point Likert scale) measured at time of discharge
5-point Likert scale with 1 - Very Unsatisfied and 5 - Very Satisfied
Time frame: At time of discharge (usually within 7 days)
Visual Function Questionnaire (NEI-VFQ-25 with 10-Item Neuro-Ophthalmic Supplement)
measure of visual function using a composite score ranging from 0-100, where higher scores indicate better function.
Time frame: Over 6, 12 and 24 months
Headache Impact Test (HIT-6)
6-question tool that measures the impact of headaches on daily life, producing a total score between 36 and 78. Higher scores indicate greater severity. Scores of 60+ indicate a very severe, 56-59 a substantial, 50-55 some, and 49 or less little to no impact.
Time frame: Over 6, 12 and 24 months
36-item Short form health survey (SF-36v2)
A patient-reported tool measuring eight health domains, scoring them from 0 to 100, where 0 represents maximum limitations and 100 represents no health restrictions
Time frame: Over 6, 12 and 24 months
EuroQol 5 dimension 5 level survey (EQ5D-5L)
The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale from 0 "worst imaginable health" to 100 "best imaginable health"
Time frame: Over 6, 12 and 24 months
Time to return to work (if working)
fewer days to return to work is better than more days to return to work
Time frame: Measured in days from date of intervention for the duration of follow up: reported over 6, 12 and 24 months
Work Productivity and Activity Impairment Questionnaire - General Health (WPAI-GH)
The WPAI measures absenteeism, presenteeism and activity impairment attributable to ill-health over the preceding 7 days. The WPAI calculates percentage impairment (maximum 100%) with higher numbers representing greater work impairment.
Time frame: Over 6, 12 and 24 months
Proportion of patients requiring ICP lowering medication above a clinically relevant threshold
Measured as a percentage of patients reporting use of ICP lowering medications
Time frame: Over 6, 12 and 24 months
Healthcare resource use questionnaire
Designed to calculate how much healthcare resource is used by each patient since the last clinic visit. This assesses the economic impact of IIH and will record any major differences in cost per QALY gained on each arm of the trial
Time frame: over 6, 12 and 24 months
Plan to share: No
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