Clinical Trial: A Longitudinal Examination of Aging With a Spinal Cord Injury: Cardiovascular, Cerebrovascular and Cognitive Consequences

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: A Longitudinal Examination of Aging With a Spinal Cord Injury: Cardiovascular, Cerebrovascular and Cognitive Consequences

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: James J. Peters Veterans Affairs Medical Center

Current Primary Outcome: Systolic Blood Pressure (mmHg) [ Time Frame: Up to 3 years ]

To determine change in systolic blood pressure from seated rest to seated cognitive testing in subjects with and without spinal cord injury.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Performance on tests of memory (PASAT) and processing speed (SDMT). [ Time Frame: Up to 3 years ]
    To compere cognitive performance on tests of working memory and processing speed in individuals with and without spinal cord injury.
  • Cerebral Blood Flow Velocity (cm/second) from the middle cerebral arteries [ Time Frame: Up to 3 years ]
    To determine change in cerebral blood flow velocity from seated rest to seated cognitive testing in subjects with and without spinal cord injury.


Original Secondary Outcome: Same as current

Information By: James J. Peters Veterans Affairs Medical Center

Dates:
Date Received: December 27, 2016
Date Started: December 2016
Date Completion: June 2019
Last Updated: January 13, 2017
Last Verified: January 2017