Understanding the link between body mass index and treatment response in idiopathic intracranial hypertension
Evolution of Body Mass Index in Idiopathic Intracranial Hypertension and Its Relationship With the Response to Treatment. Retrospective and Prospective Study
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 |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Valencia Academic / other |
| Locations | 1 site (Valencia, Valencia) |
| Trial ID | NCT06913712 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of idiopathic intracranial hypertension.
Not a fit: Patients with other headache disorders or secondary causes of increased intracranial pressure will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Valencia, Valencia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.