Clinical Trial: Evaluating Raised Intracranial Pressure Using MR Elastography

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluating Raised Intracranial Pressure Using MR Elastography

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).

Detailed Summary: 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.
Sponsor: Mayo Clinic

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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
  • 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.


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: December 15, 2016
Date Started: January 10, 2017
Date Completion: December 31, 2018
Last Updated: March 24, 2017
Last Verified: March 2017