Understanding the link between body mass index and treatment response in idiopathic intracranial hypertension
Official title: Evolution of Body Mass Index in Idiopathic Intracranial Hypertension and Its Relationship With the Response to Treatment. Retrospective and Prospective Study
Run by University of Valencia · NCT06913712 · Data updated 2026-11-12
This study is trying to see how body weight affects treatment success in people with idiopathic intracranial hypertension and what weight goals might help them feel better.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | University of Valencia Academic / other |
| Locations | 1 site (Valencia, Valencia) |
| Status | Recruiting |
| Started | June 27, 2024 |
| Main results expected | May 1, 2028 |
| Study ends | May 1, 2028 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT06913712 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a confirmed diagnosis of idiopathic intracranial hypertension.
✕Probably not a fit
Patients with other headache disorders or secondary causes of increased intracranial pressure will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the relationship between body mass index (BMI) and treatment outcomes in patients with idiopathic intracranial hypertension (IIH). It seeks to determine the BMI thresholds associated with the onset of IIH and the necessary BMI reduction for effective treatment. The study will assess how patients respond to treatments like Acetazolamide and cerebrospinal fluid diversion systems, particularly focusing on those who struggle to lose weight. By identifying specific BMI goals for individual patients, the study hopes to enhance treatment efficacy and patient awareness.
Why it matters
Potential benefit: If successful, this study could provide tailored BMI targets that improve treatment outcomes for patients with idiopathic intracranial hypertension.
How similar studies have gone: While the relationship between obesity and idiopathic intracranial hypertension is recognized, this specific approach to establishing BMI thresholds is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years and older at the time of enrollment. There is no upper age limit to ensure inclusivity across age ranges. * A confirmed diagnosis of Idiopathic Intracranial Hypertension, established according to the Dandy criteria. * The diagnostic process must exclude other potential causes of increased intracranial pressure as detailed in the 'Diagnosis' section, ensuring an accurate identification of idiopathic cases. Exclusion Criteria: * A diagnosis other than IIH, specifically: tension-type headache, Chiari I malformation, or any other headache disorder unrelated to IIH. * The presence of secondary causes of increased intracranial pressure (e.g., structural brain abnormalities, venous sinus thrombosis, or medication-induced factors).
Where it's running
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Consorcio Hospital General Universitario de Valencia
Valencia, Valencia, Spain Recruiting
Study contacts
- Study coordinator: Vicente Vanaclocha, Professor
- Email: vivava@uv.es
- Phone: + 34 963 13 18 00
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Tirzepatide for Idiopathic Intracranial Hypertension
This trial tests whether tirzepatide can help people with idiopathic intracranial hypertension by comparing it to placebo over 12 months.
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Advanced imaging techniques for understanding idiopathic intracranial hypertension
This study is testing advanced imaging techniques on patients with stubborn idiopathic intracranial hypertension to see how stenting affects their brain fluid flow and overall condition.
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Transverse sinus stenting for people with long-term intracranial hypertension on acetazolamide
This trial will test whether adding a stent in the narrowed transverse sinus helps adults with idiopathic intracranial hypertension who have been on acetazolamide for over a year but still have symptoms.
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Transverse sinus stenting for newly diagnosed idiopathic intracranial hypertension
This will test whether adding transverse venous sinus stenting to standard medical care helps adults with newly diagnosed idiopathic intracranial hypertension improve vision, headaches, or tinnitus.
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Comparing CSF shunts and dural venous sinus stents for IIH
This will test whether a CSF shunt or a dural venous sinus stent better reduces pressure and preserves vision in adults with IIH who have severe papilloedema and are at risk of vision loss.
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Evaluating eye images to assess brain pressure
This study is testing a new way to see if eye images can help tell if someone has high pressure in their brain, using a non-invasive method that could be safer than current techniques.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.