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

NCT03023163 | Completed

• 1 other identifier: WEC-16-039
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

autonomic dysreflexia; baroreceptor integrity; sympathetic integrity; vagal integrity; autonomic integrity; arterial stiffness; cognitive function; traumatic brain injury; cerebral blood flow; white matter hyperintensities; cerebral vascular resistance index

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure (mmHg)

  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 Outcomes (2)

• Performance on tests of memory (PASAT) and processing speed (SDMT).

  Up to 3 years

• Cerebral Blood Flow Velocity (cm/second) from the middle cerebral arteries

  Up to 3 years

Study Arms (4)

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

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

Interventions

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.

Longitudinal Able-Bodied Controls; Longitudinal SCI

Eligibility Criteria

• Age: 28 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• Level of injury between C1-T12;
• Non-ambulatory (wheelchair dependent);
• AIS grade A, B, or C;
• Injury occurred more than 1 year ago.

You may not qualify if:

• 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

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead
• Kessler Foundation: collaborator

Study Sites (1)

Kessler Foundation Research Center

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Autonomic Dysreflexia; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Autonomic Nervous System Diseases; Brain Injuries; Brain Diseases; Craniocerebral Trauma

Study Officials

• Jill Wecht, EdD

  James J Peters VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Health Scientist

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: January 18, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

US (1)