Measurement of Autonomic Cardiovascular Integrity in Persons With SCI
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 3/2/2019 |
| Start Date: | July 2012 |
| End Date: | June 2021 |
| Contact: | Matthew T Maher, MS |
| Email: | matthew.maher@va.gov |
| Phone: | 7185849000 |
People with a spinal cord injury (SCI) have limited ability to move and feel sensation below
the level of the SCI. Doctors and researchers have tests which determine the level of
function and sensation, this test was developed by the American Spinal Cord Injury
Association (ASIA) and has been modified over the years to improve use and sensitivity. Most
recently, the ASIA Injury classification Scale (AIS) was modified in 2011, but this test does
not include the evaluation of autonomic nervous system (ANS) impairment. However, people with
SCI do have impairment of the ANS and this may adversely affect how organ systems in the body
function. Specifically, ANS impairment tends to result in changes in heart rate and blood
pressure that may relate to the level of the SCI, but this is not fully understood. In this
investigation we hope to develop simple tests which will allow doctors and scientist the
ability to measure the amount of ANS impairment to the cardiovascular system, specifically
the heart. The first part of the study will be to determine the heart rate response to
several tests (administration of drugs and physical challenges) which will change heart rate.
These tests will be given to people with and without SCI and the heart rate response will be
compared between people with and without SCI. The bigger the difference in the heart rate
response to these test between people with and without SCI the greater degree of ANS
impairment in the people with SCI. Once this heart rate difference is determined, several
simple tests (deep breathing, saliva test, Valsalva) will be performed in people with and
without SCI to again compare the heart rate response. The second part of this study will be
to determine if the heart rate responses to the first set of tests (administration of drugs
and physical challenges) can predict the heart rate response to these simple tests (deep
breathing, saliva test, Valsalva). The aim of this study is to develop a simple battery of
tests which can be easily used by doctors and scientists to determine the degree of ANS
impairment to the heart in persons with SCI.
the level of the SCI. Doctors and researchers have tests which determine the level of
function and sensation, this test was developed by the American Spinal Cord Injury
Association (ASIA) and has been modified over the years to improve use and sensitivity. Most
recently, the ASIA Injury classification Scale (AIS) was modified in 2011, but this test does
not include the evaluation of autonomic nervous system (ANS) impairment. However, people with
SCI do have impairment of the ANS and this may adversely affect how organ systems in the body
function. Specifically, ANS impairment tends to result in changes in heart rate and blood
pressure that may relate to the level of the SCI, but this is not fully understood. In this
investigation we hope to develop simple tests which will allow doctors and scientist the
ability to measure the amount of ANS impairment to the cardiovascular system, specifically
the heart. The first part of the study will be to determine the heart rate response to
several tests (administration of drugs and physical challenges) which will change heart rate.
These tests will be given to people with and without SCI and the heart rate response will be
compared between people with and without SCI. The bigger the difference in the heart rate
response to these test between people with and without SCI the greater degree of ANS
impairment in the people with SCI. Once this heart rate difference is determined, several
simple tests (deep breathing, saliva test, Valsalva) will be performed in people with and
without SCI to again compare the heart rate response. The second part of this study will be
to determine if the heart rate responses to the first set of tests (administration of drugs
and physical challenges) can predict the heart rate response to these simple tests (deep
breathing, saliva test, Valsalva). The aim of this study is to develop a simple battery of
tests which can be easily used by doctors and scientists to determine the degree of ANS
impairment to the heart in persons with SCI.
Inclusion Criteria:
For All Groups:
- Age 18-65 years (18-89 years for Non-Invasive Only SCI Subjects)
- Stable health for > 6 months
- Non-smoker
o Subjects with SCI:
- Level of injury - C1-S4
- Duration of injury - ≥ 1 year
- AIS classification - A, B, C
Exclusion Criteria:
For Main Study SCI Group:
- Tachycardia (resting HR ≥ 100 bpm)
- Bradycardia (resting HR ≤ 40 bpm)
- Hypertension
- KNOWN:
Coronary artery disease, Chronic heart failure, Cardiac arrhythmias, Diabetes mellitus,
Thyroid disease, Renal insufficiency, Hepatic disease, Autonomic neuropathy, Ulcerative
colitis, Benign prostatic hyperplasia, Hiatal hernia, Glaucoma, Parkinson's disease,
Stroke, other neuromuscular diseases, Known sulfite allergy or hypersensitivity, Asthma,
Active illness or infection, For Non-invasives Only SCI Group
- Diabetes mellitus
- Autonomic neuropathy
- Parkinson's disease
- Active illness or infection
We found this trial at
1
site
Bronx, New York 10468
Principal Investigator: Jill M Wecht, Ed.D.
Phone: 718-584-9000
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