Measurement of Autonomic Cardiovascular Integrity in Persons With SCI

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01758692
Study type	Observational
Source	James J. Peters Veterans Affairs Medical Center
Contact
Status	Completed
Phase
Start date	July 2012
Completion date	June 30, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02574572` - Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury	Phase 1
Recruiting	`NCT05941819` - ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury	N/A
Completed	`NCT05265377` - Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury	N/A
Recruiting	`NCT02331979` - Improving Bladder Function in SCI by Neuromodulation	N/A
Completed	`NCT02777281` - Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI	N/A
Recruiting	`NCT02978638` - Electrical Stimulation for Continence After Spinal Cord Injury	N/A
Withdrawn	`NCT02237547` - Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury	Phase 1/Phase 2
Completed	`NCT02161913` - Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers	N/A
Completed	`NCT02262234` - Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study	Phase 1/Phase 2
Completed	`NCT01884662` - Virtual Walking for Neuropathic Pain in Spinal Cord Injury	N/A
Completed	`NCT01642901` - Zoledronic Acid in Acute Spinal Cord Injury	Phase 3
Terminated	`NCT02080039` - Electrical Stimulation of Denervated Muscles After Spinal Cord Injury	N/A
Terminated	`NCT01433159` - Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury	Phase 2
Completed	`NCT01471613` - Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury	Phase 1/Phase 2
Completed	`NCT01467817` - Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)	N/A
Completed	`NCT02149511` - Longitudinal Morphometric Changes Following SCI
Completed	`NCT00663663` - Telephone Intervention for Pain Study (TIPS)	N/A
Completed	`NCT01086930` - Early Intensive Hand Rehabilitation After Spinal Cord Injury	Phase 3
Completed	`NCT01025609` - Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
Terminated	`NCT01005615` - Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury	Phase 1/Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.