Magnetic Resonance Elastography in Hydrocephalus

May 15, 2023 updated by: Keith D. Paulsen, Dartmouth-Hitchcock Medical Center
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRE
Device: MRE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Investigators

  • Principal Investigator: Keith D Paulsen, PhD, Dartmouth College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2007

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

August 28, 2014

First Submitted That Met QC Criteria

September 2, 2014

First Posted (Estimate)

September 3, 2014

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMS 20618 FED07029
  • 3R01EB004632-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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