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

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ClinicalTrials.gov Identifier: NCT03023163
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : February 28, 2019
Sponsor:
Collaborator:
Kessler Foundation
Information provided by (Responsible Party):
Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center

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.

Condition or disease Intervention/treatment
Spinal Cord Injury Other: Longitudinal

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.

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: A Longitudinal Examination of Aging With a Spinal Cord Injury: Cardiovascular, Cerebrovascular and Cognitive Consequences
Study Start Date : December 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Older SCI
Individuals that are between the ages of 50-75 years old, have a traumatic SCI, level of injury between C1-T12, non-ambulatory (wheelchair dependent), AIS grade A, B, or C, and injury occurred more than 1 year ago.
Older Able-Bodied Controls
Individuals that are between the ages of 50-75 years old and primary language is English.
Longitudinal SCI
Individuals that are between the ages of 28-54 years old and previously participated in the Impact of Age on Cardiovascular, Cerebrovascular, and Cognitive Health study in a 3-5 year span.
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.

Longitudinal Able-Bodied Controls
Individuals that are between the ages of 28-54 years old and previously participated in the Impact of Age on Cardiovascular, Cerebrovascular, and Cognitive Health study in a 3-5 year span.
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.




Primary Outcome Measures :
  1. Systolic Blood Pressure (mmHg) [ Time Frame: Up to 3 years ]
    To determine change in systolic blood pressure from seated rest to seated cognitive testing in subjects with and without spinal cord injury.


Secondary Outcome Measures :
  1. Performance on tests of memory (PASAT) and processing speed (SDMT). [ Time Frame: Up to 3 years ]
    To compere cognitive performance on tests of working memory and processing speed in individuals with and without spinal cord injury.

  2. Cerebral Blood Flow Velocity (cm/second) from the middle cerebral arteries [ Time Frame: Up to 3 years ]
    To determine change in cerebral blood flow velocity from seated rest to seated cognitive testing in subjects with and without spinal cord injury.



Information from the National Library of Medicine

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Ages Eligible for Study:   28 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

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): NCT03023163


Contacts
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Contact: Caitlyn Katzelnick, MS 973-324-3588 ckatzelnick@kesslerfoundation.org

Locations
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United States, New Jersey
Kessler Foundation Research Center Recruiting
West Orange, New Jersey, United States, 07052
Contact: Caitlyn Katzelnick, MS    973-324-3581    ckatzelnick@kesslerfoundation.org   
Principal Investigator: Nancy Chiaravalloti, Ph.D         
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center
Kessler Foundation
Investigators
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Principal Investigator: Jill Wecht, EdD James J Peters VA Medical Center

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Responsible Party: Jill M. Wecht, Ed.D., Research Health Scientist, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03023163     History of Changes
Other Study ID Numbers: WEC-16-039
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019

Keywords provided by Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center:
traumatic brain injury
autonomic dysreflexia
baroreceptor integrity
sympathetic integrity
vagal integrity
autonomic integrity
arterial stiffness
cognitive function
cerebral blood flow
white matter hyperintensities
cerebral vascular resistance index

Additional relevant MeSH terms:
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Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System