Spinal Cord InjuryNCT02122991
Cardiovascular, Cerebrovascular, and Cognitive Function in Spinal Cord Injury
An observational study of Spinal Cord Injury, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
- Normal pressure hydrocephalus
- Brain tumor
- Progressive supranuclear palsy
- Seizure disorder
- Multiple sclerosis
- Any significant systemic illness or unstable medical condition, including:
- Uncontrolled diabetes mellitus,
- Uncorrected hypothyroidism or hyperthyroidism,
- Systemic cancer.
- History of schizophrenia or bipolar disorder or any active psychosis
- Alcohol or substance abuse or dependence within the past 6 months (from medical record)
Trial locations and contacts
1 site in 1 country.
United States1 site
James J Peters VA Medical Center
The Bronx, New York, 10468
About this study
Official title: Cardiovascular, Cerebrovascular, and Cognitive Function in SCI
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.
Read the detailed description
The cognitive test battery will consists of the tests listed below, administered in the order given. Each test will be scored according to the
- California Verbal Learning Test (Total \& SD?)
- Controlled oral word association test
- Symbol Digit Modalities Test (Oral version)
- Trail Making Test (Oral version)
- Stroop Test (W?, C?, CW?)
- Digit Span (Forwards, Backwards, and Sequencing)
- California Verbal Learning Test (LD? \& Recognition?)
- Letter-Number Sequencing
- California Verbal Learning Test (LD Forced recognition?)
- WASI-II Sub-tests (Vocabulary, Similarities, and Matrix Reasoning)
- 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
- Medical subject headings
- Spinal Cord Injuries, Autonomic Dysreflexia, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 2 years
Secondary outcomes (1)
Cerebral Blood Flow Velocity (cm/second) from the middle cerebral arteries
To determine change in cerebral blood flow velocity from seated rest to seated cognitive testing in subjects with and without spinal cord injury.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startJul 2013
- Primary completionAug 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center
- Investigators
- Jill M Wecht, Ed.D., Principal investigator, JJPVAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122991
- Sponsor's protocol ID
- WEC-13-024
- Other IDs
- 01492
- Status last verified
- Feb 2018
- First submitted
- 1 Jul 2013
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular, Cerebrovascular, and Cognitive Function in SCI
- ClinicalTrials.gov ID
- NCT02122991
- Acronym / sponsor ID
- WEC-13-024
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury, autonomic dysreflexia, baroreceptor integrity, sympathetic integrity, vagal integrity, autonomic integrity, arterial stiffness, cognitive function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Study start
- Jul 2013 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The cognitive test battery will consists of the tests listed below, administered in the order given. Each test will be scored according to the
- California Verbal Learning Test (Total \& SD?)
- Controlled oral word association test
- Symbol Digit Modalities Test (Oral version)
- Trail Making Test (Oral version)
- Stroop Test (W?, C?, CW?)
- Digit Span (Forwards, Backwards, and Sequencing)
- California Verbal Learning Test (LD? \& Recognition?)
- Letter-Number Sequencing
- California Verbal Learning Test (LD Forced recognition?)
- WASI-II Sub-tests (Vocabulary, Similarities, and Matrix Reasoning)
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (26 listed)
- Acute illness or infection
- Documented history of:
- Any significant history of neurological disease/disorders:
- Any significant systemic illness or unstable medical condition, including:
- History of schizophrenia or bipolar disorder or any active psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Systolic Blood Pressure (mmHg)
Time frame: Up to 2 years
To determine change in systolic blood pressure from seated rest to seated cognitive testing in subjects with and without spinal cord injury.
Performance on tests of information processing (WAIS-IV and Digit Span) and working memory (SDMT)
Time frame: up to 2 years
To compere cognitive performance on tests of working memory and information processing in individuals with and without spinal cord injury.
1 secondary outcome
Cerebral Blood Flow Velocity (cm/second) from the middle cerebral arteries
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill M Wecht, Ed.D. principal investigator
JJPVAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (mmHg) (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.