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Magnetic Resonance Elastography in Hydrocephalus

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ClinicalTrials.gov Identifier: NCT02230124
Recruitment Status : Active, not recruiting
First Posted : September 3, 2014
Last Update Posted : May 23, 2018
Sponsor:
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Keith D. Paulsen, Dartmouth-Hitchcock Medical Center

Brief Summary:
The purpose of this project is to assess the utility of a new magnetic resonance technique called magnetic resonance elastography (MRE) in the non-invasive diagnosis of normal pressure hydrocephalus. The investigators hypothesize that MRE produces a unique imaging signature for hydrocephalus that distinguishes the disease from the normal (non-hydrocephalic) but atrophied brain, a distinction not possible with conventional MR imaging studies that are presently available.

Condition or disease Intervention/treatment Phase
Hydrocephalus Device: MRE Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Elastography in Hydrocephalus
Actual Study Start Date : March 1, 2007
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus

Arm Intervention/treatment
Experimental: MRE Device: MRE



Primary Outcome Measures :
  1. Mean shear modulus [ Time Frame: 15 Years ]
    The primary outcome measure will be mean shear modulus determined from pre-operative (and pre-drain placement) MRE in patients who demonstrate clinical improvement with trial CSF drainage versus patients who do not demonstrate improvement.


Secondary Outcome Measures :
  1. Pre-operative (and pre-drain placement) shear modulus in the experimental group will be compared with various assessments of clinical improvement after VP shunting. [ Time Frame: 15 Years ]
    Secondary outcomes will compare pre- and post-drain MRE shear moduli with ventricular size and intracranial pressure.



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Ages Eligible for Study:   45 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age >21;
  • One or more of the following complaints: memory loss/dementia, urinary incontinence, or progressive gait disturbance
  • Ventriculomegaly defined as temporal horn width >2 mm or a FH:ID ratio>30% on computed tomography or MRI, where FH is the maximal distance between the frontal horns and ID is the internal diameter from inner table to inner table of the skull at this level (Greenberg)
  • A diagnosis of any adult onset hydrocephalus (NPH, post-traumatic, post-hemorrhagic, obstructive, or idiopathic) will be considered for enrollment in this study

Exclusion Criteria:

  • Implanted neuro-stimulator or cardiac pacemaker
  • Known coagulopathy; major organ dysfunction
  • End-stage congestive heart failure
  • Oxygen-dependent pulmonary disease, hepatic cirrhosis, or dialysis- dependent renal failure; or other condition which, according to the assessment of the treating surgeon or anesthesia team
  • Precludes consideration of elective surgery
  • Patients who may be pregnant will be excluded from this study as well

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): NCT02230124


Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
Principal Investigator: Keith D Paulsen, PhD Dartmouth College

Responsible Party: Keith D. Paulsen, Professor, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02230124     History of Changes
Other Study ID Numbers: DMS 20618
3R01EB004632-02 ( U.S. NIH Grant/Contract )
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018

Keywords provided by Keith D. Paulsen, Dartmouth-Hitchcock Medical Center:
Hydrocephalus

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases