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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03023163
• Other study ID #: WEC-16-039
• Status: Completed
• Start date: December 2016
• Est. completion date: December 2022

Study information

• Verified date: June 2023
• Source: James J. Peters Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Kessler Foundation Research Center	West Orange	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
James J. Peters Veterans Affairs Medical Center	Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Performance on tests of memory (PASAT) and processing speed (SDMT).	To compere cognitive performance on tests of working memory and processing speed in individuals with and without spinal cord injury.	Up to 3 years
Secondary	Cerebral Blood Flow Velocity (cm/second) from the middle cerebral arteries	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