Cardiovascular, Cerebrovascular, and Cognitive Function in Spinal Cord Injury

NCT02122991 | Completed

• 2 other identifiers: WEC-13-02401492
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Increased life expectancy in individuals with spinal cord injury (SCI) present clinicians with the challenge of managing the secondary complications of SCI with the chronic diseases common in an aging population. Cardiovascular disease, cerebral vascular disease, and cognitive dysfunction are among the primary challenges facing clinicians in the treatment of an aging population. Cognitive dysfunction has been reported in upwards of 60% of the SCI population, which have been primarily attributed to concomitant traumatic brain injury or pre-morbid conditions. Identifying possible modifiable risk factors which contribute to the increased prevalence of cognitive dysfunction in the SCI population is of significant clinical relevance and cardiovascular and cerebrovascular disorders have emerged as possible contributors to the cognitive disorders in the general population. These risk factors include: physical inactivity, chronically low or high blood pressure (BP), reduced blood flow to the brain, arterial stiffening, and impaired nervous system regulation of the cardiovascular system. These risk factors are particularly prominent in the SCI population as they represent a model of profound inactivity, have trouble regulating blood pressure, and suffer impaired cardiovascular regulation from their injury. In addition, we've recently reported deficits in blood flow to the brain at rest and during cognitive tests; with results being further impaired in SCI with chronically low blood pressure. Therefore the goals of this project are to determine the influence of cardiovascular and cerebral vascular responses at rest and during cognitive testing on test performance in 80 individuals with SCI compared to 50 age-matched non-SCI controls. All potential subjects will undergo a rigorous 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 3 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. We hypothesize that blood pressure and cerebrovascular response to testing will account significantly for performance in cognitive testing that otherwise would have been attributable to SCI status.

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

Outcome Measures

Primary Outcomes (2)

• 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 2 years

• Performance on tests of information processing (WAIS-IV and Digit Span) and working memory (SDMT)

  To compere cognitive performance on tests of working memory and information processing in individuals with and without spinal cord injury.

  up to 2 years

Secondary Outcomes (1)

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

  Up to 2 years

Study Arms (2)

Able-Bodied Controls

Subjects must be between the ages of 30 and 64 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 22 on the Montreal Cognitive Assessment. Subjects MUST NOT HAVE: an acute illness or infection, history of stroke, recent illicit drug abuse (\<6 months), unstable/uncontrolled seizures, neurodegenerative disease, Severe Traumatic Brain Injury (as determined by TBI screening tool), any significant history of neurological disease/disorder, any significant systemic illness or unstable medical condition (uncontrolled diabetes, hypo- or hyperthyroidism, systemic cancer), history of schizophrenia or bipolar disorder or any active psychosis, or alcohol/substance abuse or dependence (\<6 months).

Spinal Cord Injury

Subjects must be between the age of 30 and 64 years old, be English-literate and able to provide informed consent. They must be at least 1 year from the date of their spinal cord injury. They must score at least 20/60 minimum acuity in their worst eye on the Snell Eye Exam, and score at least 22 on the Montreal Cognitive Assessment. Subjects MUST NOT HAVE: an acute illness or infection, history of stroke, recent illicit drug abuse (\<6 months), unstable/uncontrolled seizures, neurodegenerative disease, Severe Traumatic Brain Injury (as determined by TBI screening tool), any significant history of neurological disease/disorder, any significant systemic illness or unstable medical condition (uncontrolled diabetes, hypo- or hyperthyroidism, systemic cancer), history of schizophrenia or bipolar disorder or any active psychosis, or alcohol/substance abuse or dependence (\<6 months).

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

80 subjects with chronic SCI and 50 age-matched non-SCI controls will be recruited from out-patient clinics at the JJP VAMC and the Center of Excellence. 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:

• Between the ages of 30 and 64 years old
• If SCI, the duration of injury must be greater than 1 year
• At least 20/60 minimum acuity in worst eye on the Snell Eye Exam
• A score ≥22 on the Montreal Cognitive Assessment
• English literate
• Able to provide informed consent

You may not qualify if:

• Acute illness or infection
• Documented history of:
• Stroke
• Recent illicit drug abuse (from medical chart, within the past 6-months)
• Unstable or uncontrolled seizures
• Neurodegenerative disease including Alzheimer's disease, Parkinson's disease, Huntington's disease
• Severe TBI (identified by TBI screening tool)
• Any significant history of neurological disease/disorders:
• Alzheimer's disease
• Parkinson's disease
• Vascular dementia
• Huntington's disease
• Pick's disease
• Lewy Body Dementia
• Frontotemporal dementia

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead

Study Sites (1)

James J Peters VA Medical Center

The Bronx, New York, 10468, 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, Ed.D.

  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: July 1, 2013
• First Posted: April 25, 2014
• Study Start: July 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

US (1)