<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/NCT03023163</url>
  </required_header>
  <id_info>
    <org_study_id>WEC-16-039</org_study_id>
    <nct_id>NCT03023163</nct_id>
  </id_info>
  <brief_title>A Longitudinal Examination of Aging With a Spinal Cord Injury: Cardiovascular, Cerebrovascular and Cognitive Consequences</brief_title>
  <official_title>A Longitudinal Examination of Aging With a Spinal Cord Injury: Cardiovascular, Cerebrovascular and Cognitive Consequences</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>James J. Peters Veterans Affairs Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kessler Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>James J. Peters Veterans Affairs Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The general population is aging, today 12% of the United States population is older than 65&#xD;
      and it is estimated that by 2020 the number of people in the United States older than 65 will&#xD;
      outnumber children younger than 5. As the general population ages, the spinal cord injury&#xD;
      (SCI) population is also aging and it is estimated that 14% is older than 60. Although&#xD;
      persons with SCI are living longer, life expectancy remains below that of the general&#xD;
      population with cardiovascular and cerebrovascular diseases accounting for more than 25% of&#xD;
      all deaths since 1995. Similar to findings in the general population, BP dysregulation may&#xD;
      impact cognitive function, and investigators reported poorer performance on tasks of memory&#xD;
      and attention processing in hypotensive individuals with SCI compared to a normotensive SCI&#xD;
      cohort. Thus, it is imperative that investigators work to minimize the impact of cognitive&#xD;
      deficits on these aspects of life quality in persons with SCI as they age. Therefore the&#xD;
      goals of this study are: Study 1) to compare cardiovascular, cerebrovascular and cognitive&#xD;
      function and fMRI between older individuals with SCI (50-75 years) and older age-matched&#xD;
      controls and Study 2) to determine 3-5 year longitudinal changes in cardiovascular,&#xD;
      cerebrovascular and cognitive function and fMRI in relatively young individuals with SCI&#xD;
      (28-54 years) compared to relatively young age-matched controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All potential subjects will undergo a two-part screening process which consists of an initial&#xD;
      screening via telephone and a detailed, in-person screening. Eligible subjects will be&#xD;
      invited to participate in a 4 hour laboratory visit during which their arterial stiffness,&#xD;
      blood pressure, heart rate, respiration rate and, blood flow to the brain will be monitored&#xD;
      at rest and during a comprehensive series of cognitive tests. For Study 1 (cross-sectional),&#xD;
      40 older (50-75 years) individuals with SCI and 20 age-matched non-SCI controls will be&#xD;
      recruited. For study 2 (longitudinal), 30 individuals (28-54 years) with SCI and 20&#xD;
      age-matched non-SCI will be recruited from previous enrollment in the Impact of Age on&#xD;
      Cardiovascular, Cerebrovascular and Cognitive Health in SCI study to learn the longitudinal&#xD;
      changes in cardiovascular, cerebrovascular and cognitive health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">December 2022</completion_date>
  <primary_completion_date type="Actual">December 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Systolic Blood Pressure (mmHg)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>To determine change in systolic blood pressure from seated rest to seated cognitive testing in subjects with and without spinal cord injury.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Performance on tests of memory (PASAT) and processing speed (SDMT).</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>To compere cognitive performance on tests of working memory and processing speed in individuals with and without spinal cord injury.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral Blood Flow Velocity (cm/second) from the middle cerebral arteries</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>To determine change in cerebral blood flow velocity from seated rest to seated cognitive testing in subjects with and without spinal cord injury.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">92</enrollment>
  <condition>Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>Older SCI</arm_group_label>
    <description>Individuals that are between the ages of 50-75 years old, have a traumatic SCI, level of injury between C1-T12, non-ambulatory (wheelchair dependent), AIS grade A, B, or C, and injury occurred more than 1 year ago.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Older Able-Bodied Controls</arm_group_label>
    <description>Individuals that are between the ages of 50-75 years old and primary language is English.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Longitudinal SCI</arm_group_label>
    <description>Individuals that are between the ages of 28-54 years old and previously participated in the Impact of Age on Cardiovascular, Cerebrovascular, and Cognitive Health study in a 3-5 year span.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Longitudinal Able-Bodied Controls</arm_group_label>
    <description>Individuals that are between the ages of 28-54 years old and previously participated in the Impact of Age on Cardiovascular, Cerebrovascular, and Cognitive Health study in a 3-5 year span.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Longitudinal</intervention_name>
    <description>Participants that completed the Impact of Age on Cardiovascular, Cerebrovascular, Cerebrovascular and Cognitive Health study, will be re-assessed again to compare longitudinal (3-5 years) change in blood pressure, cerebral blood flow, arterial stiffness and cognitive health.</description>
    <arm_group_label>Longitudinal Able-Bodied Controls</arm_group_label>
    <arm_group_label>Longitudinal SCI</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study 1) 40 older (50-75 years) individuals with SCI and 20 age-matched non-SCI controls.&#xD;
&#xD;
        Study 2) 30 individuals (28-54 years) with SCI and 20 age-matched non-SCI controls.&#xD;
        Participants will be recruited from the Impact of Age on Cardiovascular, Cerebrovascular&#xD;
        and Cognitive Health study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Study 1) Between the ages of 50-75 years old&#xD;
&#xD;
          -  Study 2) Between the ages of 28-54 years old&#xD;
&#xD;
          -  Completed Impact of Age on Cardiovascular, Cerebrovascular and Cognitive Health study&#xD;
&#xD;
          -  For Both:&#xD;
&#xD;
          -  Primary language is English&#xD;
&#xD;
          -  Additional Inclusion Criteria: SCI Subjects&#xD;
&#xD;
          -  Level of injury between C1-T12;&#xD;
&#xD;
          -  Non-ambulatory (wheelchair dependent);&#xD;
&#xD;
          -  AIS grade A, B, or C;&#xD;
&#xD;
          -  Injury occurred more than 1 year ago.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute illness or infection;&#xD;
&#xD;
          -  Controlled or uncontrolled hypertension or Diabetes mellitus;&#xD;
&#xD;
          -  Documented history of traumatic brain injury;&#xD;
&#xD;
          -  Stroke&#xD;
&#xD;
          -  Epilepsy or seizure disorders;&#xD;
&#xD;
          -  Multiple sclerosis &amp; Parkinson's disease;&#xD;
&#xD;
          -  Psychiatric disorders (post-traumatic stress disorder, schizophrenia, bipolar&#xD;
             disorder);&#xD;
&#xD;
          -  Alzheimer's disease &amp; dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>28 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jill Wecht, EdD</last_name>
    <role>Principal Investigator</role>
    <affiliation>James J Peters VA Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kessler Foundation Research Center</name>
      <address>
        <city>West Orange</city>
        <state>New Jersey</state>
        <zip>07052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>June 23, 2023</last_update_submitted>
  <last_update_submitted_qc>June 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>James J. Peters Veterans Affairs Medical Center</investigator_affiliation>
    <investigator_full_name>Jill M. Wecht, Ed.D.</investigator_full_name>
    <investigator_title>Research Health Scientist</investigator_title>
  </responsible_party>
  <keyword>autonomic dysreflexia</keyword>
  <keyword>baroreceptor integrity</keyword>
  <keyword>sympathetic integrity</keyword>
  <keyword>vagal integrity</keyword>
  <keyword>autonomic integrity</keyword>
  <keyword>arterial stiffness</keyword>
  <keyword>cognitive function</keyword>
  <keyword>traumatic brain injury</keyword>
  <keyword>cerebral blood flow</keyword>
  <keyword>white matter hyperintensities</keyword>
  <keyword>cerebral vascular resistance index</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT03023163
org study id: WEC-16-039
nct id: NCT03023163
lead sponsor: 
collaborator: 
has dmc: No
The general population is aging, today 12% of the United States population is older than 65
      and it is estimated that by 2020 the number of people in the United States older than 65 will
      outnumber children younger than 5. As the general population ages, the spinal cord injury
      (SCI) population is also aging and it is estimated that 14% is older than 60. Although
      persons with SCI are living longer, life expectancy remains below that of the general
      population with cardiovascular and cerebrovascular diseases accounting for more than 25% of
      all deaths since 1995. Similar to findings in the general population, BP dysregulation may
      impact cognitive function, and investigators reported poorer performance on tasks of memory
      and attention processing in hypotensive individuals with SCI compared to a normotensive SCI
      cohort. Thus, it is imperative that investigators work to minimize the impact of cognitive
      deficits on these aspects of life quality in persons with SCI as they age. Therefore the
      goals of this study are: Study 1) to compare cardiovascular, cerebrovascular and cognitive
      function and fMRI between older individuals with SCI (50-75 years) and older age-matched
      controls and Study 2) to determine 3-5 year longitudinal changes in cardiovascular,
      cerebrovascular and cognitive function and fMRI in relatively young individuals with SCI
      (28-54 years) compared to relatively young age-matched controls.
All potential subjects will undergo a two-part screening process which consists of an initial
      screening via telephone and a detailed, in-person screening. Eligible subjects will be
      invited to participate in a 4 hour laboratory visit during which their arterial stiffness,
      blood pressure, heart rate, respiration rate and, blood flow to the brain will be monitored
      at rest and during a comprehensive series of cognitive tests. For Study 1 (cross-sectional),
      40 older (50-75 years) individuals with SCI and 20 age-matched non-SCI controls will be
      recruited. For study 2 (longitudinal), 30 individuals (28-54 years) with SCI and 20
      age-matched non-SCI will be recruited from previous enrollment in the Impact of Age on
      Cardiovascular, Cerebrovascular and Cognitive Health in SCI study to learn the longitudinal
      changes in cardiovascular, cerebrovascular and cognitive health.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Systolic Blood Pressure (mmHg)
time frame: Up to 3 years
description: To determine change in systolic blood pressure from seated rest to seated cognitive testing in subjects with and without spinal cord injury.
measure: Performance on tests of memory (PASAT) and processing speed (SDMT).
time frame: Up to 3 years
description: To compere cognitive performance on tests of working memory and processing speed in individuals with and without spinal cord injury.
measure: Cerebral Blood Flow Velocity (cm/second) from the middle cerebral arteries
time frame: Up to 3 years
description: To determine change in cerebral blood flow velocity from seated rest to seated cognitive testing in subjects with and without spinal cord injury.
arm group label: Older SCI
description: Individuals that are between the ages of 50-75 years old, have a traumatic SCI, level of injury between C1-T12, non-ambulatory (wheelchair dependent), AIS grade A, B, or C, and injury occurred more than 1 year ago.
arm group label: Older Able-Bodied Controls
description: Individuals that are between the ages of 50-75 years old and primary language is English.
arm group label: Longitudinal SCI
description: Individuals that are between the ages of 28-54 years old and previously participated in the Impact of Age on Cardiovascular, Cerebrovascular, and Cognitive Health study in a 3-5 year span.
arm group label: Longitudinal Able-Bodied Controls
description: Individuals that are between the ages of 28-54 years old and previously participated in the Impact of Age on Cardiovascular, Cerebrovascular, and Cognitive Health study in a 3-5 year span.
intervention type: Other
intervention name: Longitudinal
description: Participants that completed the Impact of Age on Cardiovascular, Cerebrovascular, Cerebrovascular and Cognitive Health study, will be re-assessed again to compare longitudinal (3-5 years) change in blood pressure, cerebral blood flow, arterial stiffness and cognitive health.
arm group label: Longitudinal Able-Bodied Controls
arm group label: Longitudinal SCI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 28 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jill Wecht, EdD
role: Principal Investigator
affiliation: James J Peters VA Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: James J. Peters Veterans Affairs Medical Center
investigator full name: Jill M. Wecht, Ed.D.
investigator title: Research Health Scientist
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries