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Trial record 18 of 37 for:    idiopathic intracranial hypertension

Evaluating Raised Intracranial Pressure Using MR Elastography

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ClinicalTrials.gov Identifier: NCT03096743
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
John J Chen, Mayo Clinic

Brief Summary:
Investigators will compare magnetic resonance (MR) elastography measurements to other forms of noninvasive methods of detecting raised intracranial pressure, including optical coherence tomography (OCT) imaging measurements of the retinal nerve fiber layer (RNFL) and indirect signs of raised intracranial pressure on magnetic resonance imaging (MRI).

Condition or disease Intervention/treatment Phase
Idiopathic Intracranial Hypertension Radiation: MR elastography Radiation: MRI structural brain imaging Procedure: Lumbar puncture Other: Optical Coherence Tomography (OCT) imaging Radiation: Optic nerve B-scan ultrasound Not Applicable

Detailed Description:
The goal of this study is to evaluate the brain elasticity in patients with idiopathic intracranial hypertension (IIH) and other forms of raised intracranial pressure, such as obstructive hydrocephalus. Investigators will evaluate for a correlation between brain stiffness and opening pressure on lumbar puncture. Investigators will also evaluate for changes in brain stiffness after interventions that are aimed at lowering intracranial pressure, including lumbar punctures, medications, and surgical interventions, such as ventriculoperitoneal shunts. Lastly, investigators will compare MR elastography measurements to other forms of noninvasive methods of detecting raised intracranial pressure, including optical coherence tomography (OCT) measurements of the retinal nerve fiber layer (RNFL) and indirect signs of raised intracranial pressure on MRI.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluating Raised Intracranial Pressure Using MR Elastography
Actual Study Start Date : January 10, 2017
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with increased intracranial hypertension
Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, Optic nerve B-scan ultrasound and Lumbar puncture.
Radiation: MR elastography
MR elastography image acquisition will be conducted on the Compact 3T MRI scanner using a modified single-shot spin-echo echo-planar imaging pulse sequence.

Radiation: MRI structural brain imaging
MRI structural brain imaging will be done on the Compact 3T MRI at the same time as MR elastography.

Procedure: Lumbar puncture
All patients with papilledema will get lumbar punctures with opening pressure as part of their work-up for papilledema. A small number of patients without increased intracranial pressure will receive a lumbar puncture.

Other: Optical Coherence Tomography (OCT) imaging
Optical Coherence Tomography (OCT) imaging will measure the peripapillary retinal nerve fiber layer (RNFL) thickness measurements The images with enhanced depth imaging will be obtained to measure the Bruch's membrane orientation.

Radiation: Optic nerve B-scan ultrasound
Ultrasound will be used to measure the optic nerve sheath diameter 3 mm posterior to the posterior scleral surface.

Experimental: Patient without raised intracranial hypertension
Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, and Optic nerve B-scan ultrasound. Some patients will receive lumbar punctures.
Radiation: MR elastography
MR elastography image acquisition will be conducted on the Compact 3T MRI scanner using a modified single-shot spin-echo echo-planar imaging pulse sequence.

Radiation: MRI structural brain imaging
MRI structural brain imaging will be done on the Compact 3T MRI at the same time as MR elastography.

Other: Optical Coherence Tomography (OCT) imaging
Optical Coherence Tomography (OCT) imaging will measure the peripapillary retinal nerve fiber layer (RNFL) thickness measurements The images with enhanced depth imaging will be obtained to measure the Bruch's membrane orientation.

Radiation: Optic nerve B-scan ultrasound
Ultrasound will be used to measure the optic nerve sheath diameter 3 mm posterior to the posterior scleral surface.




Primary Outcome Measures :
  1. MR elastography measurement of the brain elasticity [ Time Frame: 1-2 weeks prior to lumbar puncture ]
    The primary outcome measure is the difference in the brain elasticity on MR elastography between patients with raised intracranial pressure and those with normal intracranial pressure


Secondary Outcome Measures :
  1. MRI finding [ Time Frame: 1--2 weeks prior to lumbar puncture ]
    The secondary outcome measurement are the retinal nerve fiber layer (RNFL) thickness and Bruch's membrane configuration on the MRI findings of raised intracranial pressure (optic nerve sheath diameter and pituitary/sella ratio). The cutoff from abnormal-to-normal will be established. The sensitivity and specificities will be established and compared against the other secondary outcome measurements and against MR elastography.

  2. Ocular Coherence Tomography (OCT) finding [ Time Frame: 1--2 weeks prior to lumbar puncture ]
    The secondary outcome measurements are the retinal nerve fiber layer (RNFL) thickness and Bruch's membrane configuration using ocular coherence tomography (OCT) of raised intracranial pressure (optic nerve sheath diameter and pituitary/sella ratio). The cutoff from abnormal-to-normal will be established. The sensitivity and specificities will be established and compared against the other secondary outcome measurements and against MR elastography

  3. Optic Nerve B-scan ultrasound finding [ Time Frame: 1--2 weeks prior to lumbar puncture ]
    The secondary outcome measurement are the retinal nerve fiber layer (RNFL) thickness and Bruch's membrane configuration on the optic nerve B-scan ultrasound findings of raised intracranial pressure (optic nerve sheath diameter and pituitary/sella ratio). The cutoff from abnormal-to-normal will be established. The sensitivity and specificities will be established and compared against the other secondary outcome measurements and against MR elastography.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

All subjects will have the following inclusion criteria:

  • Group 1: Papilledema from idiopathic intracranial hypertension and other forms of elevated intracranial pressure, including obstructive hydrocephalus
  • Group 2: Patients without raised intracranial pressure.

All subjects will have the following exclusion criteria:

  • Age <18
  • Pregnancy (self-reported)
  • Individuals for whom MR is contraindicated

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03096743


Contacts
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Contact: John J. Chen, M.D., Ph.D. 507-284-7140 chen.john@mayo.edu
Contact: Jacqueline A. Leavitt, M.D. 507-284-6263 leavitt.jacqueline@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jessica Morgan    507-293-9689    nolte.jessica@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: John J Chen, M.D., Ph.D. Mayo Clinic

Additional Information:
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Responsible Party: John J Chen, M.D., Ph.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT03096743     History of Changes
Other Study ID Numbers: 16-007037
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Intracranial Hypertension
Pseudotumor Cerebri
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases