Clinical Trial: Cardiovascular, Cerebrovascular, and Cognitive Function in Spinal Cord Injury

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Cardiovascular, Cerebrovascular, and Cognitive Function in SCI

Brief Summary:

Increased life expectancy in individuals with spinal cord injury (SCI) present clinicians with the challenge of managing the secondary complications of SCI with the chronic diseases common in an aging population. Cardiovascular disease, cerebral vascular disease, and cognitive dysfunction are among the primary challenges facing clinicians in the treatment of an aging population. Cognitive dysfunction has been reported in upwards of 60% of the SCI population, which have been primarily attributed to concomitant traumatic brain injury or pre-morbid conditions. Identifying possible modifiable risk factors which contribute to the increased prevalence of cognitive dysfunction in the SCI population is of significant clinical relevance and cardiovascular and cerebrovascular disorders have emerged as possible contributors to the cognitive disorders in the general population. These risk factors include: physical inactivity, chronically low or high blood pressure (BP), reduced blood flow to the brain, arterial stiffening, and impaired nervous system regulation of the cardiovascular system. These risk factors are particularly prominent in the SCI population as they represent a model of profound inactivity, have trouble regulating blood pressure, and suffer impaired cardiovascular regulation from their injury. In addition, we've recently reported deficits in blood flow to the brain at rest and during cognitive tests; with results being further impaired in SCI with chronically low blood pressure. Therefore the goals of this project are to determine the influence of cardiovascular and cerebral vascular responses at rest and during cognitive testing on test performance in 80 individuals with SCI compared to 50 age-matched non-SCI controls. All potential subjects will undergo a rigorous two-part screening process which consists of an initial screening via telephone and a detailed, in-person screening. Eligible subjects will be invited to

Detailed Summary:

The cognitive test battery will consists of the tests listed below, administered in the order given. Each test will be scored according to the

  1. California Verbal Learning Test (Total & SD?)
  2. Controlled oral word association test
  3. Symbol Digit Modalities Test (Oral version)
  4. Trail Making Test (Oral version)
  5. Stroop Test (W?, C?, CW?)
  6. Digit Span (Forwards, Backwards, and Sequencing)
  7. California Verbal Learning Test (LD? & Recognition?)
  8. Letter-Number Sequencing
  9. California Verbal Learning Test (LD Forced recognition?)
  10. WASI-II Sub-tests (Vocabulary, Similarities, and Matrix Reasoning)

Sponsor: James J. Peters Veterans Affairs Medical Center

Current Primary Outcome:

  • Systolic Blood Pressure (mmHg) [ Time Frame: Up to 2 years ]
    To determine change in systolic blood pressure from seated rest to seated cognitive testing in subjects with and without spinal cord injury.
  • Performance on tests of information processing (WAIS-IV and Digit Span) and working memory (SDMT) [ Time Frame: up to 2 years ]
    To compere cognitive performance on tests of working memory and information processing in individuals with and without spinal cord injury.


Original Primary Outcome: Same as current

Current Secondary Outcome: Cerebral Blood Flow Velocity (cm/second) from the middle cerebral arteries [ Time Frame: Up to 2 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: July 1, 2013
Date Started: July 2013
Date Completion: March 2017
Last Updated: March 9, 2017
Last Verified: March 2017