Impact of Age on Cardiovascular, Cerebrovascular and Cognitive Health in Spinal Cord Injury
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
The cognitive test battery will consists of the tests listed below, administered in the order given.
- Digit Span
- California Verbal Learning Test
- Symbol Digit Modalities Test
- Letter Number Sequencing
- California Verbal Learning Test Delay
- Paced Auditory Serial Addition Test
- D-KEFS Verbal Fluency
- D-KEFS Color-Word
- WASI Vocabulary
- WASI Matrix Reasoning
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
New Jersey
-
West Orange, New Jersey, Forente stater, 07052
- Kessler Foundation Research Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Arterial Stiffness
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Performance on Cognition Battery Tests
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Volume of White Matter Hyperintensities
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jill M Wecht, EdD, JJPVAMC
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- WEC-13-042
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .