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

16 oktober 2017 bijgewerkt door: Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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

Studietype

Observationeel

Inschrijving (Werkelijk)

120

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • New Jersey
      • West Orange, New Jersey, Verenigde Staten, 07052
        • Kessler Foundation Research Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

25 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Arterial Stiffness
Tijdsspanne: Up to 2 years
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
Tijdsspanne: 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.
Up to 2 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Performance on Cognition Battery Tests
Tijdsspanne: 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.
Up to 2 years

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Volume of White Matter Hyperintensities
Tijdsspanne: 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.
Up to 2 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

James J. Peters Veterans Affairs Medical Center

Medewerkers

Kessler Foundation

Onderzoekers

  • Hoofdonderzoeker: Jill M Wecht, EdD, JJPVAMC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2013

Primaire voltooiing (Werkelijk)

1 juli 2017

Studie voltooiing (Werkelijk)

1 juli 2017

Studieregistratiedata

Eerst ingediend

8 november 2013

Eerst ingediend dat voldeed aan de QC-criteria

8 november 2013

Eerst geplaatst (Schatting)

14 november 2013

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 oktober 2017

Laatste update ingediend die voldeed aan QC-criteria

16 oktober 2017

Laatst geverifieerd

1 oktober 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • WEC-13-042

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