Magnetic Resonance Elastography in Hydrocephalus

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Brief Title

Magnetic Resonance Elastography in Hydrocephalus

Official Title

Magnetic Resonance Elastography in Hydrocephalus

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.
    



Study Type

Interventional


Primary Outcome

Mean shear modulus

Secondary Outcome

 Pre-operative (and pre-drain placement) shear modulus in the experimental group will be compared with various assessments of clinical improvement after VP shunting.

Condition

Hydrocephalus

Intervention

MRE

Study Arms / Comparison Groups

 MRE
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

35

Start Date

March 1, 2007

Completion Date

June 30, 2023

Primary Completion Date

June 30, 2023

Eligibility 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
      

Gender

All

Ages

45 Years - 95 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Keith D Paulsen, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02230124

Organization ID

DMS 20618 FED07029

Secondary IDs

3R01EB004632-02

Responsible Party

Principal Investigator

Study Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

 National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Study Sponsor

Keith D Paulsen, PhD, Principal Investigator, Dartmouth College


Verification Date

February 2022