<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02230124</url>
  </required_header>
  <id_info>
    <org_study_id>DMS 20618 FED07029</org_study_id>
    <secondary_id>3R01EB004632-02</secondary_id>
    <nct_id>NCT02230124</nct_id>
  </id_info>
  <brief_title>Magnetic Resonance Elastography in Hydrocephalus</brief_title>
  <official_title>Magnetic Resonance Elastography in Hydrocephalus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Biomedical Imaging and Bioengineering (NIBIB)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to assess the utility of a new magnetic resonance technique&#xD;
      called magnetic resonance elastography (MRE) in the non-invasive diagnosis of normal pressure&#xD;
      hydrocephalus. The investigators hypothesize that MRE produces a unique imaging signature for&#xD;
      hydrocephalus that distinguishes the disease from the normal (non-hydrocephalic) but&#xD;
      atrophied brain, a distinction not possible with conventional MR imaging studies that are&#xD;
      presently available.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 1, 2007</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean shear modulus</measure>
    <time_frame>15 Years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pre-operative (and pre-drain placement) shear modulus in the experimental group will be compared with various assessments of clinical improvement after VP shunting.</measure>
    <time_frame>15 Years</time_frame>
    <description>Secondary outcomes will compare pre- and post-drain MRE shear moduli with ventricular size and intracranial pressure.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Hydrocephalus</condition>
  <arm_group>
    <arm_group_label>MRE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRE</intervention_name>
    <arm_group_label>MRE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;21;&#xD;
&#xD;
          -  One or more of the following complaints: memory loss/dementia, urinary incontinence,&#xD;
             or progressive gait disturbance&#xD;
&#xD;
          -  Ventriculomegaly defined as temporal horn width &gt;2 mm or a FH:ID ratio&gt;30% on computed&#xD;
             tomography or MRI, where FH is the maximal distance between the frontal horns and ID&#xD;
             is the internal diameter from inner table to inner table of the skull at this level&#xD;
             (Greenberg)&#xD;
&#xD;
          -  A diagnosis of any adult onset hydrocephalus (NPH, post-traumatic, post-hemorrhagic,&#xD;
             obstructive, or idiopathic) will be considered for enrollment in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Implanted neuro-stimulator or cardiac pacemaker&#xD;
&#xD;
          -  Known coagulopathy; major organ dysfunction&#xD;
&#xD;
          -  End-stage congestive heart failure&#xD;
&#xD;
          -  Oxygen-dependent pulmonary disease, hepatic cirrhosis, or dialysis- dependent renal&#xD;
             failure; or other condition which, according to the assessment of the treating surgeon&#xD;
             or anesthesia team&#xD;
&#xD;
          -  Precludes consideration of elective surgery&#xD;
&#xD;
          -  Patients who may be pregnant will be excluded from this study as well&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Keith D Paulsen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dartmouth College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>May 15, 2023</last_update_submitted>
  <last_update_submitted_qc>May 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>Keith D. Paulsen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Hydrocephalus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrocephalus</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02230124
org study id: DMS 20618 FED07029
secondary id: 3R01EB004632-02
nct id: NCT02230124
lead sponsor: 
collaborator: 
has dmc: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Mean shear modulus
time frame: 15 Years
description: 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.
measure: 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
description: Secondary outcomes will compare pre- and post-drain MRE shear moduli with ventricular size and intracranial pressure.
arm group label: MRE
arm group type: Experimental
intervention type: Device
intervention name: MRE
arm group label: MRE
criteria: 
gender: All
minimum age: 45 Years
maximum age: 95 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Keith D Paulsen, PhD
role: Principal Investigator
affiliation: Dartmouth College
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: Keith D. Paulsen
investigator title: Professor
mesh term: Hydrocephalus