Idiopathic Intracranial Hypertension (IIH) - neurology, neuro-ophthalmology. Nervous System Diseases Benign intracranial hypertension
Conditions
Interventions
Patients are randomised 1:1 to bariatric surgery or dietetic intervention.
1. 32 participants randomised to the bariatric surgery arm of the trial will be referred to the surgery pathway to receive l
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female IIH patients aged between 18 and 55 years, diagnosed according to the modified Dandy criteria who have chronic (> 2 months duration), active disease (visual impairment, papilloedema, significantly raised ICP > 25 cmH2O) and normal brain imaging (magnetic resonance imaging and venography as noted at diagnosis) 2. Body mass index (BMI) >35 kg/m2 3. Tried other appropriate non-surgical treatments to lose weight but have not been able to achieve or maintain adequate, clinically beneficial weight loss for at least 6 months 4. Able to give informed consent
Exclusion criteria
Exclusion criteria: Original exclusion criteria: 1. Age less than 18 or older than 55 years 2. Pregnant 3. Significant co-morbidity, endocrinopathy or the use of hormone-manipulating medication 4. Undergone optic nerve sheath fenestration 5. Definite indication for or contraindication against surgery or dieting 6. Have a specific medical or psychiatric contraindication for surgery, including drug misuse, eating disorder or major depression (suicidal ideation, drug overdose or psychological admission in last 12 months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Intracranial Pressure (ICP) between baseline and 12 months measured by lumbar puncture at baseline and 12 months. ICP will be recorded to the nearest whole number in cmH2O | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome Measures: 1. Change in ICP between baseline and 24 and 60 months measured by lumbar puncture. ICP will be recorded to the nearest whole number in cmH2O 2. Change in reported IIH symptoms from 0 to 12 months (and at 3, 6, 24 and 60 months) measured by clinician-completed CRFs and participant-completed questionnaire 3. Change in visual function from 0 to 12 months (and at 24 and 60 months). This will be measured by the LogMAR (log of the minimum angle of resolution) chart to assess visual acuity, automated perimetry (Humphrey 24-2 central threshold) to measure the visual field mean deviation, a Pelli-Robson chart to evaluate contrast sensitivity and an Ishihara book to assess colour vision. 4. Change in papilloedema from 0 to 12 months (and at 24 and 60 months). This will be measured using spectral optical coherence tomography. Papilloedema will be further graded by blinded assessment of, and assignation of Frisen score to, fundus photographs. 5. Change in headache-associated disability from 0 to 12 months (and at 24 and 60 months) measured by participant-completed questionnaire including analgesic use, Headache Index, and Headache Impact Test-6 6. Change in anthropological measures (e.g. waist, hip, fat mass) from 0 to 12 months (and at 24 and 60 months) 7. Change in quality of life (participant reported) from 0 to 12 months (and at 24 and 60 months) measured by participant-reported questionnaire (EQ-5D-5L and ICECAP-A questionnaires) 8. Difference in number of referrals to Cerebrospinal Fluid (CSF) shunting procedures and optic nerve sheath fenestration between treatment arms at 0 to 12 months (and at 24 and 60 months). This will be measured on clinical follow-up CRFs. 9. Health economics including cost-effectiveness at 12, 24 and 60 months measured by participant-reported health resource usage questionnaire and EQ-5D-5L and ICECAP-A questionnaires Sub-study Exploratory Outcome Measures: 1. Change in apnoea-hypopnoea index from 0 to 12 months 2. | — |
Countries
England, United Kingdom
Outcome results
None listed