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NCT Number: NCT03023163

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

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.

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Key information

Conditions

Spinal Cord Injury Autonomic Dysreflexia Autonomic Nervous System Diseases Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

28 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kessler Foundation Research Center

West Orange, New Jersey, 07052, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Longitudinal

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

James J. Peters Veterans Affairs Medical Center

Fed

Collaborators

  • Kessler Foundation

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2017
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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