Impact of Age on Cardiovascular, Cerebrovascular and Cognitive Health in Spinal Cord Injury

NCT01984476 | Completed

• 1 other identifier: WEC-13-042
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

As the spinal cord injured population ages, these individuals are being exposed to an increased prevalence of age-associated diseases, which coupled with the secondary complications of the injury may contribute to the reduced life expectancies. Decentralized autonomic regulation in persons with SCI results in a multitude of cardiovascular changes, which may contribute to accelerated aging. Adverse cardiovascular changes may have deleterious effects on cerebral blood flow dynamics and an increase in cerebral vascular resistance index in individuals with SCI during cognitive testing. Deficits in memory and processing speed in individuals with SCI may relate to cardiovascular and cerebrovascular dysfunction. Identifying the associations between healthy aging versus premature or accelerated aging in organ system function in the SCI population is an important first step towards prevention and amelioration of these changes. Therefore the study objectives are to compare, among individuals with SCI, age-matched non-SCI and older non-SCI individuals arterial stiffness and cerebral vascular resistance index; memory, processing speed, and executive function; and volume of white matter hyperintensities. 60 individuals with SCI, 30 age-matched non-SCI controls, and 20 older non-SCI controls will be recruited for 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. A subset of the participants will be asked to take part in an MRI brain imaging session: 40 persons with SCI, 10 age-matched non-SCI and 10 older non-SCI. Eligible subjects will be asked to participate in a 1 hour MRI/functional magnetic resonance imaging(fMRI) session. We hypothesize that arterial stiffness and cerebral vascular resistance index will be increased in the SCI group compared to the age-matched non-SCI but will be comparable to the older non-SCI groups. In addition, we hypothesize that the prevalence of mild to moderate cognitive impairments in memory, processing speed, and executive function will be increased in the SCI individuals compared to the age-matched non-SCI but will be comparable to the older non-SCI individuals.

Conditions

Spinal Cord Injury

Keywords

spinal cord injury; 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 (2)

• Arterial Stiffness

  To determine the difference in arterial stiffness among individuals with SCI to age-matched non-SCI and older non-SCI.

  Up to 2 years

• Cerebral Vascular Resistance Index

  To determine the difference in cerebral vascular resistance index among individuals with SCI to age-matched non-SCI and older non-SCI.

  Up to 2 years

Secondary Outcomes (1)

• Performance on Cognition Battery Tests

  Up to 2 years

Other Outcomes (1)

• Volume of White Matter Hyperintensities

  Up to 2 years

Study Arms (3)

Older Able-Bodied Controls

Subjects must be between the age of 55 and 65 years old, be English-literate and able to provide informed consent. They must score at least 20/60 minimum acuity in their worst eye on the Snell Eye Exam, and score at least 24 on the Montreal Cognitive Assessment. Subjects MUST NOT HAVE: an acute illness or infection, history of stroke, recent illicit drug abuse (\<6 months), controlled or uncontrolled hypertension or diabetes mellitus, history of epilepsy or other seizure disorder, history of Traumatic Brain Injury (as determined by TBI screening tool), any significant history of neurological disease/disorder, and diagnosis of a psychiatric disorder such as post-traumatic stress disorder, schizophrenia or bipolar disorder.

Spinal Cord Injured

Subjects must be between the age of 25 and 49 years old, be English-literate and able to provide informed consent. They must be injured between 5 to 10 years, level of injury between C1-T12, non-ambulatory (wheelchair dependent), and AIS grade of A or B. They must score at least 20/60 minimum acuity in their worst eye on the Snell Eye Exam, and score at least 24 on the Montreal Cognitive Assessment. Subjects MUST NOT HAVE: an acute illness or infection, history of stroke, recent illicit drug abuse (\<6 months), controlled or uncontrolled hypertension or diabetes mellitus, history of epilepsy or other seizure disorder, history of Traumatic Brain Injury (as determined by TBI screening tool), any significant history of neurological disease/disorder, and diagnosis of a psychiatric disorder such as post-traumatic stress disorder, schizophrenia or bipolar disorder.

Age-Matched Able-Bodied Controls

Subjects must be between the age of 25 and 49 years old, be English-literate and able to provide informed consent. They must score at least 20/60 minimum acuity in their worst eye on the Snell Eye Exam, and score at least 24 on the Montreal Cognitive Assessment. Subjects MUST NOT HAVE: an acute illness or infection, history of stroke, recent illicit drug abuse (\<6 months), controlled or uncontrolled hypertension or diabetes mellitus, history of epilepsy or other seizure disorder, history of Traumatic Brain Injury (as determined by TBI screening tool), any significant history of neurological disease/disorder, and diagnosis of a psychiatric disorder such as post-traumatic stress disorder, schizophrenia or bipolar disorder.

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

60 subjects with SCI, 30 age-matched non-SCI controls and 20 older non-SCI controls will be recruited from out-patient clinics at Kessler Institute for Rehabilitation. This includes subjects who have completed various protocols in the Cardiovascular autonomic testing laboratory or patients referred by their physicians following routine physical examinations. Physicians will be informed of the inclusion and exclusion criteria for this study and will be able to provide us with the assurance that the patient is an appropriate candidate for the study and that he/she was willing to speak with the study coordinators.

You may qualify if:

• SCI
• Between the ages of 25 and 49 years old
• Duration of injury must be between 5 and 10 years
• AIS grade of A or B
• Non-ambulatory (wheelchair dependent)
• At least 20/60 minimum acuity in worst eye on the Snell Eye Exam
• A score ≥24 on the Montreal Cognitive Assessment
• English literate
• Able to provide informed consent
• Age-matched non-SCI
• Between the ages of 25 and 49 years old
• At least 20/60 minimum acuity in worst eye on the Snell Eye Exam
• A score ≥24 on the Montreal Cognitive Assessment
• English literate
• Able to provide informed consent

You may not qualify if:

• Acute illness or infection
• Documented history of:
• Controlled or uncontrolled hypertension or Diabetes mellitus
• Recent illicit drug abuse (from medical chart, within the past 6-months)
• Epilepsy or seizures
• Neurodegenerative disease including Alzheimer's disease, Parkinson's disease, Dementia, Stroke, Multiple sclerosis
• Severe TBI (identified by TBI screening tool)
• Any significant history of psychiatric disease/disorders:
• Post-traumatic stress disorder
• schizophrenia
• Bipolar disease
• Substance abuse or dependence within the past 6 months
• Subject has been informed that it is medically unsafe to receive a regular MRI as part of my medical care
• Pregnant
• Right handed

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 M Wecht, EdD

  JJPVAMC

  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: November 8, 2013
• First Posted: November 14, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 17, 2017

Record last verified: 2017-10

Locations

US (1)