Measurement of Autonomic Cardiovascular Integrity in Persons With SCI

NCT ID: NCT01758692

Last Updated: 2023-06-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 177 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2021-06-30

Brief Summary

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.

Conditions

Spinal Cord Injury

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Able-bodied Controls

10 controls between the ages of 18 and 65 of either gender; free of cardiovascular disease and/or medication.

An addition 40 controls ages 18-89 of either gender, will perform the non-invasive manipulations only.

No interventions assigned to this group

Spinal Cord Injury

40 subjects to perform the pharmacological and non-invasive manipulations; between the ages of 18 and 65 years old in stable health for the last 6 months, non-smoker, and level of injury from C1 - S4 for over 1 year and an AIS classification of A, B, C. Free of arrhythmia, hypertension, cardiovascular disease, kidney disease, diabetes, neuropathies, neuromuscular disease, and sulfite allergies or hypersensitivity.

60 subjects to perform the non-invasive manipulations only; between 18-89 years of age in stable condition (>6 months), non-smoker. Level of injury from C1-S4 for over a year with a AIS classification of A, B, or C. No history of diabetes, autonomic neuropathy, parkinson's disease, or acute illness or infection. An additional 30 will perform the non-invasive testing before and after completion of an ambulatory training protocol.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

James J. Peters Veterans Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Jill M. Wecht, Ed.D.

Health Science Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jill M Wecht, Ed.D.

Role: PRINCIPAL_INVESTIGATOR

JJPVAMC

Locations

James J Peters VA Medical Center

The Bronx, New York, United States

Countries

United States

References

Wecht JM, Maher MT, Kirshblum SC, Escalon MX, Weir JP. Sit-up test to assess orthostatic hypotension in individuals with spinal cord injury. Clin Auton Res. 2025 Jun;35(3):393-405. doi: 10.1007/s10286-024-01102-8. Epub 2025 Mar 4.

Reference Type: DERIVED

PMID: 40032720 (View on PubMed)

Other Identifiers

01436

Identifier Type: OTHER

Identifier Source: secondary_id

WEC-12-06

Identifier Type: -

Identifier Source: org_study_id