Assessment of ICP in Idiopathic Intracranial Hypertension Using Transocular Ultrasound and Transcranial Doppler

NCT04314128 | Completed DMC

• 1 other identifier: H-19029542
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Idiopathic Intracranial Hypertension (IIH) is a rare disease, primarily affecting overweight females of child-bearing age. Patients suffer from increased intracranial pressure (ICP), typically resulting in headaches, visual disturbances and bilateral papilledema, pulsatile tinnitus and cognitive deficits. The disease is difficult to diagnose, treat and monitor. The only current method of measuring the ICP in day-to-day clinical practice is by lumbar puncture. This procedure is invasive, and often painful for the patient. There is an unmet need of methods that can reliable measure or estimate ICP in a non-invasive manner. Ultrasound is one such potential method, and the aim of this study is to investigate the use of ocular ultrasound and transcranial doppler to measure or estimate ICP.

Conditions

Idiopathic Intracranial Hypertension

Outcome Measures

Primary Outcomes (3)

• Correlation between opening pressure and ONSD

  Optic nerve sheath diameter (ONSD) potential correlation with opening pressure.

  1 year

• Correlaton between opening pressure and ONSD/ETD ratio

  ONSD/ETD (external transverse diameter) ratio and potential correlation with opening pressure.

  1 year

• Comparison of ONSD in IIH and healthy controls

  Comparison of ONSD in patients with elevated ICP (IIH) and healthy controls, age- sex and BMI matched.

  1 year

Secondary Outcomes (10)

• Optic disc elevation

  1 year

• ONSD diameter on MR c in patients with IIH

  1 year

• Changes in the optic nerve (ONSD)

  1 month

• Changes in the optic nerve (ONSD)

  6 months

• Changes in the optic nerve (ODE)

  1 month

Study Arms (1)

Patients suspected of IIH at baseline

OTHER

Intervention: TOS and TCD measurements at baseline, and at routine follow-ups. Healthy controls will be recruited to match the patients.

Diagnostic Test: TOS and TCD

Interventions

TOS and TCD DIAGNOSTIC_TEST

TOS: Transorbital sonography TCD: Transcranial Doppler

Patients suspected of IIH at baseline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• Patients in whom the IIH diagnosis is suspected/or confirmed
• The diagnosis of migraine with or without aura or tension-type headache is allowed as a comorbid headache type.
• Participants must read and understand the Danish language, or have an official interpreter present to be able to understand the work-up and sign the participation consent for the study

You may not qualify if:

• Pregnant or breastfeeding females
• Patients who do not need a diagnostic lumbar puncture at the time of evaluation
• Any other primary or secondary headache diagnosis than migraine with or without aura or tension type headache as a comorbid disorder
• Patients in whom the examination cannot be performed due to anatomical reasons such as severe head dysmorphia or severe ophthalmological diseases
• Participants with secondary causes of raised intracranial pressure, or patients that have been treated for such (e.g. brain tumor, hydrocephalus, stroke or severe head injury)
• Participants with known atherosclerotic disease or known heart disease
• CONTROL GROUP (ARM 2):
• Age 18-65
• Healthy persons who do not suffer from any form of primary headache except infrequent tension-type headache
• Participants must read and understand the Danish language or have an official interpreter present to be able to sign the participation consent for the study.
• Pregnant or breastfeeding females
• Participants in whom the examination cannot be performed due to anatomical reasons such as severe head dysmorphia or severe ophthalmological diseases

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Glostrup Municipality, Capital Region, 2600, Denmark

Location

MeSH Terms

Conditions

Pseudotumor Cerebri

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Rigmor Jensen, Dr.med.

  Danish Headache Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Single group, prospective cohort study with healthy controls.

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 19, 2020
• Study Start: January 1, 2020
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)