Spinal Cord InjuryNCT03023163
A Longitudinal Examination of Aging With a Spinal Cord Injury: Cardiovascular, Cerebrovascular and Cognitive Consequences
An observational study of Spinal Cord Injury, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Longitudinal
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Dec 2022
- 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 28 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- Level of injury between C1-T12;
- Non-ambulatory (wheelchair dependent);
- AIS grade A, B, or C;
- Injury occurred more than 1 year ago.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kessler Foundation Research Center
West Orange, New Jersey, 07052
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Longitudinal
- Keywords
- 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
- 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.
LongitudinalOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Longitudinal | |
| 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. Receives: Other: Longitudinal |
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 3 years
Secondary outcomes (2)
Performance on tests of memory (PASAT) and processing speed (SDMT).
To compere cognitive performance on tests of working memory and processing speed in individuals with and without spinal cord injury.
Measured: Up to 3 years
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 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionDec 2022
- Study completionDec 2022
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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Kessler Foundation
- Responsible party
- Principal investigator, Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center
- Investigators
- Jill Wecht, EdD, Principal investigator, James J Peters VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023163
- Sponsor's protocol ID
- WEC-16-039
- Status last verified
- Jun 2023
- First submitted
- 27 Dec 2016
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Examination of Aging With a Spinal Cord Injury: Cardiovascular, Cerebrovascular and Cognitive Consequences
- ClinicalTrials.gov ID
- NCT03023163
- Acronym / sponsor ID
- WEC-16-039
- Conditions
- Spinal Cord Injury
- Keywords
- autonomic dysreflexia, baroreceptor integrity, sympathetic integrity, vagal integrity, autonomic integrity, arterial stiffness, cognitive function, traumatic brain injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Kessler Foundation
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 18 Jan 2017 (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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: LongitudinalIndividuals 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. |
| Longitudinal Able-Bodied Controls | – | Other: LongitudinalIndividuals 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. |
Who may qualify
- Ages
- 28 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- Acute illness or infection;
- Controlled or uncontrolled hypertension or Diabetes mellitus;
- Documented history of traumatic brain injury;
- Stroke
- Epilepsy or seizure disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LongitudinalParticipants 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. | Other | Longitudinal Able-Bodied Controls, Longitudinal SCI |
Primary outcome
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.
2 secondary outcomes
Performance on tests of memory (PASAT) and processing speed (SDMT).
Time frame: Up to 3 years
Cerebral Blood Flow Velocity (cm/second) from the middle cerebral arteries
Time frame: Up to 3 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 26 Jun 2023.
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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 Wecht, EdD principal investigator
James J Peters VA Medical Center
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 10 inclusion and 8 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 26 Jun 2023. 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 3 years). 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 26 Jun 2023.