Ireland
--:--IST
Recruiting Observational

BMI in Idiopathic Intracranial Hypertension and Its Relationship With the Response to Treatment

NCT06913712 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2024-06-27
Last updated
2026-04-22

Condition(s) studied

Idiopathic Intracranial Hypertension (IIH)

Investigational drug(s) / intervention(s)

Weight loss without pharmacotherapy

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.

Study summary

1. To establish the correlation between the evolution of the body mass index in benign intracranial hypertension and the response to treatments.
2. To establish the BMI at which this disease occurs.
3. To establish how much the BMI must be reduced to cure this disease.
4. To assess the evolution and response to treatments of sick people who DO NOT reduce or even continue to increase their BMI despite treatment with Acetazolamide or a possible CSF diversion

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Response to treatment — Through study completion, an average of 1 year
    BMI evolution in patients with benign intracranial hypertension and its relationship with the evolution of the patient's symptoms

Trial sites (1)

FacilityCityRegionStatus
Consorcio Hospital General Universitario de Valencia Valencia Valencia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06913712 on ClinicalTrials.gov ↗ ← All trials in Spain