Clinical trial NCT03023163: A Longitudinal Examination of Aging With a Spinal Cord Injury: Cardiovascular, Cerebrovascular and Cognitive Consequences
Official title: A Longitudinal Examination of Aging With a Spinal Cord Injury: Cardiovascular, Cerebrovascular and Cognitive Consequences
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: James J. Peters Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Kessler Foundation
First posted: 2017-01-18
Enrollment: 92
Sex: ALL
Minimum age (years): 28
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Systolic Blood Pressure (mmHg)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Performance on tests of memory (PASAT) and processing speed (SDMT).
timeFrame: Up to 3 years
measure: Cerebral Blood Flow Velocity (cm/second) from the middle cerebral arteries
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation Research Center
state: New Jersey
Study officials:
affiliation: James J Peters VA Medical Center
name: Jill Wecht, EdD
role: PRINCIPAL_INVESTIGATOR
References: