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Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension

NCT04032379 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2023-03-07

No results posted yet for this study

Summary

Idiopathic intracranial hypertension (IIH) is a condition of unknown etiology, primarily affecting overweight females of childbearing age. Typically, patients experience headache and visual symptoms due to increased intracranial pressure (ICP) and papilledema. The diagnosis is difficult, and outcomes vary from no sequelae to blindness or chronic headaches. No clear prognostic indicators exist. Treatment consists of medication, weight loss, and possibly surgical intervention.There is an unmet need of defining biomarkers with prognostic or diagnostic value and defining predictors of a poor outcome.

This project is a prospective, population-based cohort study including clinical data and a biobank (blood samples and cerebrospinal fluid).

The investigator's primary aim is to identify biomarkers of diagnostic or prognostic value and to create a clinical IIH database. The clinical database will answer questions about patient characteristics at baseline and during follow-up, identify predictors of outcome, and help create a standardized programme for follow-up and

Conditions

  • Benign Intracranial Hypertension

Interventions

OTHER

Standard treatment

No intervention, some patients have additional neuro-psychological testing.

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • Danish Headache Center

    lead OTHER

Principal Investigators

  • Rigmor Jensen, M.D., Dr.Med. · The Danish Headache Center, Rigshospitalet-Glostrup

  • Dagmar Beier, M.D., Ph.D. · Odense University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-14
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04032379 on ClinicalTrials.gov