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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01984476
Recruitment Status : Completed
First Posted : November 14, 2013
Last Update Posted : October 17, 2017
Sponsor:
Collaborator:
Kessler Foundation
Information provided by (Responsible Party):
Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center

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.


Condition or disease
Spinal Cord Injury

Detailed Description:

The cognitive test battery will consists of the tests listed below, administered in the order given.

  1. Digit Span
  2. California Verbal Learning Test
  3. Symbol Digit Modalities Test
  4. Letter Number Sequencing
  5. California Verbal Learning Test Delay
  6. Paced Auditory Serial Addition Test
  7. D-KEFS Verbal Fluency
  8. D-KEFS Color-Word
  9. WASI Vocabulary
  10. WASI Matrix Reasoning

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Impact of Age on Cardiovascular, Cerebrovascular and Cognitive Health in Spinal Cord Injury
Study Start Date : July 2013
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Arterial Stiffness [ Time Frame: Up to 2 years ]
    To determine the difference in arterial stiffness among individuals with SCI to age-matched non-SCI and older non-SCI.

  2. Cerebral Vascular Resistance Index [ Time Frame: Up to 2 years ]
    To determine the difference in cerebral vascular resistance index among individuals with SCI to age-matched non-SCI and older non-SCI.


Secondary Outcome Measures :
  1. Performance on Cognition Battery Tests [ Time Frame: Up to 2 years ]
    To compare memory, processing speed, and executive function among individuals with SCI to age-matched non-SCI and older non-SCI.


Other Outcome Measures:
  1. Volume of White Matter Hyperintensities [ Time Frame: Up to 2 years ]
    To determine the difference in volume of white matter hyperintensities among individuals with SCI to age-matched non-SCI and older non-SCI.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Older non-SCI

  • Between the ages of 55 and 65 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

Exclusion Criteria:

  • 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

MRI has additional exclusion:

  • Subject has been informed that it is medically unsafe to receive a regular MRI as part of my medical care
  • Pregnant
  • Right handed
  • Prone to claustrophobia
  • Metal in body including:
  • metal fragments or pieces in subject's eye or any other part of body
  • brain stimulators
  • pacemakers, or other implanted electrical devices or pumps
  • aneurysm clips
  • metallic prostheses (including metal pins and rods, heart valves)
  • internal hearing aids
  • permanent eyeliner
  • shrapnel fragments
  • piercing that cannot be taken out

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01984476


Locations
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United States, New Jersey
Kessler Foundation Research Center
West Orange, New Jersey, United States, 07052
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center
Kessler Foundation
Investigators
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Principal Investigator: Jill M Wecht, EdD JJPVAMC

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Responsible Party: Jill M. Wecht, Ed.D., Research Health Scientist, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01984476    
Other Study ID Numbers: WEC-13-042
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Keywords provided by Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center:
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
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System