<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/NCT03041441</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00078211</org_study_id>
    <nct_id>NCT03041441</nct_id>
  </id_info>
  <brief_title>Non-invasive Estimation of CSF Pressure Using MRI in Patients With Spontaneous Intracranial Hypotension</brief_title>
  <official_title>Non-invasive Estimation of CSF Pressure Using MRI in Patients With Spontaneous Intracranial Hypotension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to estimate the intracranial pressure (ICP, the pressure in your&#xD;
      head) in subjects with intracranial hypotension (a condition caused by leakage of the fluid&#xD;
      that surrounds your brain and spine) using non-invasive magnetic resonance imaging (MRI)&#xD;
      techniques, and to determine whether changes in estimated ICP are seen after treatment of&#xD;
      this condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects with known intracranial hypotension who are scheduled to undergo standard-of-care&#xD;
      CSF pressure measurement using lumbar puncture prior to planned epidural patch treatment will&#xD;
      first undergo a research MRI of the brain in order to estimate ICP. The imaging protocol is&#xD;
      listed in Appendix 1. All research scans are performed without intravenous contrast.&#xD;
      Approximate scan time per session will be 20-22 minutes.&#xD;
&#xD;
      Subjects will then undergo lumbar puncture according to the standard-of-care treatment plan.&#xD;
      Estimated values of CSF pressure derived from MRI will be compared to values measured during&#xD;
      lumbar puncture. Patients will then undergo standard-of-care epidural patching. A repeat&#xD;
      research MRI after epidural patching will be performed to assess for differences in pre- and&#xD;
      post-treatment scans.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 2017</start_date>
  <completion_date type="Actual">October 26, 2019</completion_date>
  <primary_completion_date type="Actual">October 25, 2019</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>Intracranial Pressure Measurements Estimated by the MRICP Technique.</measure>
    <time_frame>During scan, approximately 30 minutes</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cerebro Spinal Fluid Pressure Measured by Lumbar Puncture</measure>
    <time_frame>During lumbar procedure, up to 2 hours</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Intracranial Pressure Estimated With MR Technique</measure>
    <time_frame>Baseline, 24 hours</time_frame>
    <description>Description: assessment of change in estimated ICP prior to and following standard-of-care epidural patching; and (2) evaluate changes in diameter and flow velocity through the transverse dural venous sinus prior to and following epidural blood patching.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Caliber to the Transverse Venous Sinus Caliber</measure>
    <time_frame>Baseline, 24 hours</time_frame>
    <description>Change in caliber to the Transverse Venous Sinus caliber has measured by non-contrast 3D phase contrast MR venography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Flow Velocity Through the Transverse Dural Venous Sinus</measure>
    <time_frame>Baseline, 24 hours</time_frame>
    <description>Description:Change in Flow velocity through the Transverse Dural venous sinus has measured by non-contrast 3D phase contrast MR venography</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Intracranial Hypotension</condition>
  <arm_group>
    <arm_group_label>MRICP method</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI algorithm</intervention_name>
    <description>MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion</description>
    <arm_group_label>MRICP method</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lumbar puncture</intervention_name>
    <description>Lumbar puncture according to the standard-of-care treatment plan.</description>
    <arm_group_label>MRICP method</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Epidural patching</intervention_name>
    <description>Epidural patching will be performed to the standard-of -care treatment plan</description>
    <arm_group_label>MRICP method</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Known diagnosis of intracranial hypotension, established by the following criteria:&#xD;
             the presence of orthostatic headache, and one or more of the following criteria: prior&#xD;
             CSF opening pressure ≤6 cmH20, demonstration of an active spinal CSF leak on prior&#xD;
             spine imaging, or cranial MRI changes of intracranial hypotension.15&#xD;
&#xD;
          -  Ability to provide informed consent.&#xD;
&#xD;
          -  Expected ability to complete standard-of-care procedures (lumbar puncture and epidural&#xD;
             patching)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known contraindication to MRI (pacemaker, MRI incompatible hardware, etc.)&#xD;
&#xD;
          -  Severe claustrophobia or other condition requiring the need for anxiolysis, sedation,&#xD;
             or any other medication for MRI scanning&#xD;
&#xD;
          -  Inability or expected inability to complete study interventions as scheduled&#xD;
&#xD;
          -  Any known contraindication to standard-of-care procedures (e.g. coagulopathy, allergic&#xD;
             reaction to required medication, lack of vascular access, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Kranz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <results_first_submitted>July 10, 2020</results_first_submitted>
  <results_first_submitted_qc>July 10, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 28, 2020</results_first_posted>
  <last_update_submitted>July 10, 2020</last_update_submitted>
  <last_update_submitted_qc>July 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Hypotension</mesh_term>
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 16, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03041441/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>MRICP Method</title>
          <description>MRI algorithm: MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion&#xD;
Lumbar puncture: Lumbar puncture according to the standard-of-care treatment plan.&#xD;
Epidural patching: Epidural patching will be performed to the standard-of -care treatment plan</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>MRICP Method</title>
          <description>MRI algorithm: MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion&#xD;
Lumbar puncture: Lumbar puncture according to the standard-of-care treatment plan.&#xD;
Epidural patching: Epidural patching will be performed to the standard-of -care treatment plan</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Intracranial Pressure Measurements Estimated by the MRICP Technique.</title>
        <description>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.</description>
        <time_frame>During scan, approximately 30 minutes</time_frame>
        <population>Data not collected on 4 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>MRICP Method</title>
            <description>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.&#xD;
MRI algorithm: MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion&#xD;
Lumbar puncture: Lumbar puncture according to the standard-of-care treatment plan.&#xD;
Epidural patching: Epidural patching will be performed to the standard-of -care treatment plan</description>
          </group>
        </group_list>
        <measure>
          <title>Intracranial Pressure Measurements Estimated by the MRICP Technique.</title>
          <description>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.</description>
          <population>Data not collected on 4 participants.</population>
          <units>cm H20</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cerebro Spinal Fluid Pressure Measured by Lumbar Puncture</title>
        <description>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.</description>
        <time_frame>During lumbar procedure, up to 2 hours</time_frame>
        <population>Data not collected on 4 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>MRICP Method</title>
            <description>MRI algorithm: MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion&#xD;
Lumbar puncture: Lumbar puncture according to the standard-of-care treatment plan.&#xD;
Epidural patching: Epidural patching will be performed to the standard-of -care treatment plan</description>
          </group>
        </group_list>
        <measure>
          <title>Cerebro Spinal Fluid Pressure Measured by Lumbar Puncture</title>
          <description>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.</description>
          <population>Data not collected on 4 participants.</population>
          <units>cm H20</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Intracranial Pressure Estimated With MR Technique</title>
        <description>Description: assessment of change in estimated ICP prior to and following standard-of-care epidural patching; and (2) evaluate changes in diameter and flow velocity through the transverse dural venous sinus prior to and following epidural blood patching.</description>
        <time_frame>Baseline, 24 hours</time_frame>
        <population>Data not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>MRICP Method</title>
            <description>MRI algorithm: MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion&#xD;
Lumbar puncture: Lumbar puncture according to the standard-of-care treatment plan.&#xD;
Epidural patching: Epidural patching will be performed to the standard-of -care treatment plan</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Intracranial Pressure Estimated With MR Technique</title>
          <description>Description: assessment of change in estimated ICP prior to and following standard-of-care epidural patching; and (2) evaluate changes in diameter and flow velocity through the transverse dural venous sinus prior to and following epidural blood patching.</description>
          <population>Data not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Caliber to the Transverse Venous Sinus Caliber</title>
        <description>Change in caliber to the Transverse Venous Sinus caliber has measured by non-contrast 3D phase contrast MR venography.</description>
        <time_frame>Baseline, 24 hours</time_frame>
        <population>Data not collected on 2 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>MRICP Method</title>
            <description>MRI algorithm: MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion&#xD;
Lumbar puncture: Lumbar puncture according to the standard-of-care treatment plan.&#xD;
Epidural patching: Epidural patching will be performed to the standard-of -care treatment plan</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Caliber to the Transverse Venous Sinus Caliber</title>
          <description>Change in caliber to the Transverse Venous Sinus caliber has measured by non-contrast 3D phase contrast MR venography.</description>
          <population>Data not collected on 2 participants.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Flow Velocity Through the Transverse Dural Venous Sinus</title>
        <description>Description:Change in Flow velocity through the Transverse Dural venous sinus has measured by non-contrast 3D phase contrast MR venography</description>
        <time_frame>Baseline, 24 hours</time_frame>
        <population>Data not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>MRICP Method</title>
            <description>MRI algorithm: MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion&#xD;
Lumbar puncture: Lumbar puncture according to the standard-of-care treatment plan.&#xD;
Epidural patching: Epidural patching will be performed to the standard-of -care treatment plan</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Flow Velocity Through the Transverse Dural Venous Sinus</title>
          <description>Description:Change in Flow velocity through the Transverse Dural venous sinus has measured by non-contrast 3D phase contrast MR venography</description>
          <population>Data not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to 30 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>MRICP Method</title>
          <description>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.&#xD;
MRI algorithm: MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion&#xD;
Lumbar puncture: Lumbar puncture according to the standard-of-care treatment plan.&#xD;
Epidural patching: Epidural patching will be performed to the standard-of -care treatment plan</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Research Coordiantor</name_or_title>
      <organization>Duke University Dept of Radiology</organization>
      <phone>(919) 684-7732</phone>
      <email>christopher.vallanat@duke.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03041441
org study id: Pro00078211
nct id: NCT03041441
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
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.
Subjects with known intracranial hypotension who are scheduled to undergo standard-of-care
      CSF pressure measurement using lumbar puncture prior to planned epidural patch treatment will
      first undergo a research MRI of the brain in order to estimate ICP. The imaging protocol is
      listed in Appendix 1. All research scans are performed without intravenous contrast.
      Approximate scan time per session will be 20-22 minutes.

      Subjects will then undergo lumbar puncture according to the standard-of-care treatment plan.
      Estimated values of CSF pressure derived from MRI will be compared to values measured during
      lumbar puncture. Patients will then undergo standard-of-care epidural patching. A repeat
      research MRI after epidural patching will be performed to assess for differences in pre- and
      post-treatment scans.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Intracranial Pressure Measurements Estimated by the MRICP Technique.
time frame: During scan, approximately 30 minutes
description: 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.
measure: Cerebro Spinal Fluid Pressure Measured by Lumbar Puncture
time frame: During lumbar procedure, up to 2 hours
description: 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.
measure: Change in Intracranial Pressure Estimated With MR Technique
time frame: Baseline, 24 hours
description: Description: assessment of change in estimated ICP prior to and following standard-of-care epidural patching; and (2) evaluate changes in diameter and flow velocity through the transverse dural venous sinus prior to and following epidural blood patching.
measure: Change in Caliber to the Transverse Venous Sinus Caliber
time frame: Baseline, 24 hours
description: Change in caliber to the Transverse Venous Sinus caliber has measured by non-contrast 3D phase contrast MR venography.
measure: Change in Flow Velocity Through the Transverse Dural Venous Sinus
time frame: Baseline, 24 hours
description: Description:Change in Flow velocity through the Transverse Dural venous sinus has measured by non-contrast 3D phase contrast MR venography
arm group label: MRICP method
arm group type: Experimental
description: 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.
intervention type: Device
intervention name: MRI algorithm
description: MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion
arm group label: MRICP method
intervention type: Procedure
intervention name: Lumbar puncture
description: Lumbar puncture according to the standard-of-care treatment plan.
arm group label: MRICP method
intervention type: Procedure
intervention name: Epidural patching
description: Epidural patching will be performed to the standard-of -care treatment plan
arm group label: MRICP method
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Kranz, MD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Intracranial Hypotension
mesh term: Hypotension
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 