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

June 23, 2023 updated by: Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Kessler Foundation Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Study 1) 40 older (50-75 years) individuals with SCI and 20 age-matched non-SCI controls.

Study 2) 30 individuals (28-54 years) with SCI and 20 age-matched non-SCI controls. Participants will be recruited from the Impact of Age on Cardiovascular, Cerebrovascular and Cognitive Health study.

Description

Inclusion Criteria:

  • Study 1) Between the ages of 50-75 years old
  • Study 2) Between the ages of 28-54 years old
  • Completed Impact of Age on Cardiovascular, Cerebrovascular and Cognitive Health study
  • For Both:
  • Primary language is English
  • Additional Inclusion Criteria: SCI Subjects
  • Level of injury between C1-T12;
  • Non-ambulatory (wheelchair dependent);
  • AIS grade A, B, or C;
  • Injury occurred more than 1 year ago.

Exclusion Criteria:

  • Acute illness or infection;
  • Controlled or uncontrolled hypertension or Diabetes mellitus;
  • Documented history of traumatic brain injury;
  • Stroke
  • Epilepsy or seizure disorders;
  • Multiple sclerosis & Parkinson's disease;
  • Psychiatric disorders (post-traumatic stress disorder, schizophrenia, bipolar disorder);
  • Alzheimer's disease & dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Older SCI
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.
Older Able-Bodied Controls
Individuals that are between the ages of 50-75 years old and primary language is English.
Longitudinal SCI
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.
Other: Longitudinal
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.
Longitudinal Able-Bodied Controls
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.
Other: Longitudinal
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 3 years
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.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

James J. Peters Veterans Affairs Medical Center

Collaborators

Kessler Foundation

Investigators

  • Principal Investigator: Jill Wecht, EdD, James J Peters VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

December 27, 2016

First Submitted That Met QC Criteria

January 13, 2017

First Posted (Estimated)

January 18, 2017

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WEC-16-039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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