Measurement of Autonomic Cardiovascular Integrity in Persons With SCI

NCT01758692 | Completed

• 2 other identifiers: WEC-12-0601436
• Study Type: observational
• Target: 177
• Locations: 1 country
• Sites: 1

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

Keywords

spinal cord injury; autonomic integrity; autonomic dysreflexia; baroreceptor integrity; sympathetic integrity; vagal integrity

Outcome Measures

Primary Outcomes (1)

• Autonomic Classification

  To characterize the individual level and completeness of autonomic impairment using simultaneous pharmacological and physical provocation in persons with SCI with varying AIS classifications of motor/sensory impairment. From these studies we anticipate a more precise diagnosis of the degree of autonomic cardiovascular impairment in individuals with SCI. Data from the pharmacologic and physical interventions will be used to determine the validity of currently available clinical tools used in other populations of autonomic failure to diagnose the degree of cardiovascular autonomic impairment for use in the SCI population.

  January 2015

Secondary Outcomes (5)

• Edrophonium chloride as a test of cardio-vagal receptor integrity at the sinoatrial (SA) node

  January 2015

• Glycopyrrolate as a test of cardio-vagal efferent integrity

  January 2015

• Esmolol hydrochloride as a test of cardiac-specific (β1) sympathetic receptor integrity

  January 2015

• Cold Face Test

  January 2015

• Head-up Tilt Test

  January 2015

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Forty subjects with chronic SCI and 10 age and gender matched able-bodied controls will be recruited. A subgroup of 20 subjects with SCI will be recruited solely for the non-invasive portion of the study. These patients will not undergo the pharmacological/placebo administration or any of the manipulations being performed in the ICU. An additional 30 subjects will complete the non-invasive portion before and after completion of an ambulatory training protocol. This includes subjects who have completed various protocols in the Cardioautonomic Program or patients referred by their physician 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead

Study Sites (1)

James J Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

Related Publications (1)

• 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.

  PMID: 40032720 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Two catecholamine samples are collected either pre/post tilt (in the ICU) or positional shift (in the autonomics lab). Samples are collected once for individuals participants in the non-invasive testing only subgroup, twice for individuals participating in the ambulatory training subgroup, and on all 4 visits for individuals participating in the main group.

MeSH Terms

Conditions

Spinal Cord Injuries; Autonomic Dysreflexia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Autonomic Nervous System Diseases

Study Officials

• Jill M Wecht, Ed.D.

  JJPVAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Science Specialist

Study Record Dates

• First Submitted: December 27, 2012
• First Posted: January 1, 2013
• Study Start: July 1, 2012
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

US (1)