A Study Of Optic Nerve Ultrasounds In Headaches Related To CSF Dynamic Disorders

Overview

About this study

The purpose of this study is to assess the utility of ONSD measurements in patients with IIH and sIH and its correlation with objective parameters such as Opening Pressure (OP), Retinal Nerve Fiber Layer (RNFL) thickness, papilledema grade, Visual Field Mean Deviation (VF MD).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Age ≥18 years
Diagnosis of Intracranial Hypertension (IIH) or spontaneous Intracranial hypotension (sIH).
Ability to provide informed consent and comply with the study procedures
Healthy controls without another neurological disease who provide informed consent for a non-invasive orbital ultrasound and a non-dilated eye examination that will include OCT and fundus photos to clearly rule-out optic disc edema.

Exclusion Criteria:

Age under 18 years
Pregnancy
Known contraindication to optic nerve ultrasound (ONUS) such as orbital trauma or orbital surgery.
Known orbital pathology or history of orbital surgery that may affect optic nerve sheath diameter (ONSD) measurements.
Neurological or systemic conditions known to alter ONSD such as optic neuritis, uncontrolled hypertension and optic nerve edema from structural or non-IIH causes.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/15/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Amaal Starling, M.D.	Open for enrollment

Mayo Clinic Location

Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Amaal Starling, M.D.

Open for enrollment

More information

Publications

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