An observational study in Idiopathic Intracranial Hypertension (IIH), sponsored by University of Valencia. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by University of Valencia · Observational
There is unanimity that one of the causes of benign intracranial hypertension is obesity. However, there is no agreement on the upper limit of BMI above which this disease occurs or the lower limit above which it is cured. People affected by this disease often have extreme difficulty losing weight and it is not uncommon for them to have followed various diets over the years to lose weight. In general, patients prefer to take medication or to undergo surgery with the implantation of a cerebrospinal fluid diversion system that does not force them to sacrifice following a strict diet. Unfortunately, those who do not manage to lose weight noticeably present repeated complications due to malfunction of the CSF diversion system with headaches and a progressive loss of visual acuity. Among other reasons, it must be considered that cerebrospinal fluid diversion systems work by pressure gradient. Since obesity increases the pressure inside the peritoneal cavity, these shunt systems will be ineffective because they will not be able to drain even if the pressure of the shunt valve is diminished to levels below 6 mm Hg.
The aim of this study is to find out what the specific BMI goal should be for each patient in particular and to be able to make them aware of this so that they make an effort and achieve it. Patients are referred to Endocrinology to be recommended the diet to follow. In some cases, bariatric surgery is used. Still, as it does not require effort or awareness on the part of these people, it is not uncommon for them to gain weight again and for benign intracranial hypertension to recur. The usual thing is that their evolution is torpid and the repeated therapeutic attempts are fruitless or plagued by complications. Weight loss using medication such as Ozempic (Semaglutide) is not accepted internationally nor contemplated by the Endocrinology Service of the General University Hospital of Valencia. On the one hand, it has no indication and on the other hand, the possible complications are not known. In addition, patients who take it on their own initially lose weight, but when they stop taking the medication they quickly regain the lost weight as a result of not having adopted healthy eating habits.
52 studies on the registry are indexed under Pseudotumor Cerebri; 21 are open to participants now.
This study's planned enrollment of 25 is below the median of 62 across 16 observational studies indexed under Pseudotumor Cerebri.
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This study is designed to be a retrospective-prospective cohort study. Data was collected from all retrospective patients attended in the last 10 years by the Neurosurgery department at Hospital General Universitario de Valencia who presented idiopathic intracranial hypertension (IIH) and were accepted to participate. Data were extracted and reviewed from the patient's medical records.
Exclusion Criteria:
Patients with Idiopathic Intracranial Hypertension
Other: Weight loss without pharmacotherapy
The study will record the weight of the patients with Idiopathic Intracranial Hypertension every three months. It will correlate with the response to the different treatment modalities (weight loss with no other intervention, diuretic drugs (acetazolamide), lumboperitoneal shunt, or ventriculoperitoneal shunt). No medication will be provided to help lose weight.
Response to treatment
BMI evolution in patients with benign intracranial hypertension and its relationship with the evolution of the patient's symptoms
Time frame: Through study completion, an average of 1 year
Plan to share: No
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University of Valencia