Non-invasive Estimation of CSF Pressure Using MRI in Patients With Spontaneous Intracranial Hypotension

NCT03041441 | Completed Results FDA Device

• 1 other identifier: Pro00078211
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to estimate the intracranial pressure (ICP, the pressure in your head) in subjects with intracranial hypotension (a condition caused by leakage of the fluid that surrounds your brain and spine) using non-invasive magnetic resonance imaging (MRI) techniques, and to determine whether changes in estimated ICP are seen after treatment of this condition.

Conditions

Intracranial Hypotension

Outcome Measures

Primary Outcomes (2)

• Intracranial Pressure Measurements Estimated by the MRICP Technique.

  The measurement of the momentary differences between the volumes of blood and CSF entering and leaving the cranium during the cardiac cycle provides an estimate of the intracranial volume change, and the pressure difference is estimated using the derivative of the CSF velocities.

  During scan, approximately 30 minutes

• Cerebro Spinal Fluid Pressure Measured by Lumbar Puncture

  The CSF pressure measured at lumbar puncture (LP), is 100-180 mm of H2O (8-15 mm Hg) with the patient lying on the side and 200-300 mm with the patient sitting up.

  During lumbar procedure, up to 2 hours

Secondary Outcomes (3)

• Change in Intracranial Pressure Estimated With MR Technique

  Baseline, 24 hours

• Change in Caliber to the Transverse Venous Sinus Caliber

  Baseline, 24 hours

• Change in Flow Velocity Through the Transverse Dural Venous Sinus

  Baseline, 24 hours

Study Arms (1)

MRICP method

EXPERIMENTAL

MRI sequences have been developed that may be able to estimate ICP in a non-invasive fashion.6-10 The MRI-based method for measurement of ICP (MRICP method) is based on basic principles of the cranio-spinal CSF physiology: The mono-exponential relationship between intracranial volume and pressure leads to a linear relationship between elastance (i.e., the derivative of pressure with respect to volume) and pressure.

Device: MRI algorithm; Procedure: Lumbar puncture; Procedure: Epidural patching

Interventions

MRI algorithm DEVICE

MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion

MRICP method

Lumbar puncture PROCEDURE

Lumbar puncture according to the standard-of-care treatment plan.

MRICP method

Epidural patching PROCEDURE

Epidural patching will be performed to the standard-of -care treatment plan

MRICP method

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Known diagnosis of intracranial hypotension, established by the following criteria: the presence of orthostatic headache, and one or more of the following criteria: prior CSF opening pressure ≤6 cmH20, demonstration of an active spinal CSF leak on prior spine imaging, or cranial MRI changes of intracranial hypotension.15
• Ability to provide informed consent.
• Expected ability to complete standard-of-care procedures (lumbar puncture and epidural patching)

You may not qualify if:

• Known contraindication to MRI (pacemaker, MRI incompatible hardware, etc.)
• Severe claustrophobia or other condition requiring the need for anxiolysis, sedation, or any other medication for MRI scanning
• Inability or expected inability to complete study interventions as scheduled
• Any known contraindication to standard-of-care procedures (e.g. coagulopathy, allergic reaction to required medication, lack of vascular access, etc.)

Sponsors & Collaborators

• Duke University: lead
• University of Miami: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Intracranial Hypotension

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Research Coordiantor
• Organization: Duke University Dept of Radiology

christopher.vallanat@duke.edu

(919) 684-7732

Study Officials

• Peter Kranz, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 2, 2017
• Study Start: September 14, 2017
• Primary Completion: October 25, 2019
• Study Completion: October 26, 2019
• Last Updated: July 28, 2020
• Results First Posted: July 28, 2020

Record last verified: 2020-07

Locations

US (1)