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Trial record 36 of 48 for:    cord blood | ( Map: Canada )

Mechanisms of Orthostatic Intolerance in Spinal Cord Injured Individuals and Following Bed Rest

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00175773
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : October 1, 2019
Information provided by (Responsible Party):
Andrei Krassioukov, University of British Columbia

Brief Summary:
The primary purpose of this study is to investigate the relationship between the extent of neurologic (nerve) impairment in patients with spinal cord injuries and how well the nerves passing down the spine to the heart and blood vessels are working. These nerves are called the descending spinal sympathetic pathway (DSSP) and are important in controlling many functions, including blood pressure. We also wish to examine how injury severity and DSSP function influence blood levels of nor-epinephrine and epinephrine. Nor-epinephrine and epinephrine are hormones released into the blood that are also important in controlling blood pressure. Thus, we will also look at how the effect of the extent of DSSP dysfunction influences heart rate and blood pressure and blood levels of certain enzymes.

Condition or disease
Spinal Cord Injury

Detailed Description:

Subjects Healthy able-bodied control volunteers, individuals with acute and chronic spinal cord injury, and individuals who have undergone a period of bed rest.

ASIA and SSR Assessment. The severity of injury to the motor and sensory spinal pathways will be documented in accordance to the American Spinal Injury Association (ASIA). The sympathetic skin response (SSR) will be examined in order to determine the completeness of injury to the DSSP. SSRs will be recorded in subjects in supine position, with the room temperature between 21-25oC. Subjects will rest supine for at least 30 min before the beginning of the examination. The procedure will take approximately 20-30 min. Self-adhesive electrodes will be applied to the hands and feet of the patient. SSRs will be recorded bilaterally and simultaneously from both hands and feet over 5 s and sampled at a band pass of 3Hz to 3 kHz. The median nerve will be stimulated (0.2ms duration, 10-20mA intensity) and 5-10 SSRs samples will be recorded. The latency and amplitude of SSRs will be measured and compared in each case.

"Sit up test". We will use a sit-up test to evaluate blood pressure control and orthostatic tolerance. Before the test the subject will lie down on a tilt table, in a temperature controlled environment for a period of 10 min. Then the subject will be passively seated to 90° and will keep this position without moving for 20 minutes. The test will be aborted if subjects become lightheaded or symptomatic. All individuals with SCI will be assessed for the continuity of the DSSP. Continuous non-invasive BP (Finometer, FMS, Arnhem, The Netherlands) and ECG (lead II, 3 electrodes on the thorax), monitoring will be performed pre-test, during and post-test. In all subjects the following measurements are planned: recordings of BP and ECG during 10 min in supine and 20 min in sitting position. Two blood samples will be collected prior to the sit-up test after 30 min of rest in supine position and 3-5 min after sit-up test. Serum level catecholamines will be examined. Butterfly catheters will be inserted at least 30 min prior to the sit-up test. This will allow the collection of blood without additional stress to the participant and activation of catecholamines release by venopuncture. Two blood samples will be drawn to determine the serum levels of NE and E from the antecubital vein of each individual before and immediately after the orthostatic challenge.

Circadian rhythm and 24hr Holter monitoring of ECG. We will obtain continuous HR recordings and following analysis will determine the beat-to-beat HRV during the 24 hr period. The subject will wear a portable unit connected with electrodes on the chest-wall. During the day the subject can do normal daily activities. We will analyze at least 3 measurement points (10 min interval) during the day and night periods in each individual. HRV analysis will occur off-line: briefly, we will use an autoregressive model for the frequency domain variables of HRV: low-frequency power (LF, 0.04-0.15 Hz), and high-frequency power (HF, 0.15-0.4 Hz). LF power is believed to represent sympathetic tone while HF power represents parasympathetic tone.

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Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mechanisms of Orthostatic Intolerance in Spinal Cord Injured Individuals and Following Bed Rest
Study Start Date : November 2004
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
SCI individuals (19 to 55 years of age) with a functionally complete or a functionally incomplete spinal cord injury will constitute the study population.

Inclusion Criteria:

1. SCI individuals (19 to 55 years of age) with a functionally complete or a functionally incomplete spinal cord injury will constitute the study population. These groups will be subdivided according to whether the SCI is acute or chronic. 2. Neurologically intact, age-matched control individuals who are confined to bedrest for 5-7 days as the result of a musculoskeletal condition (eg. following a pelvic/acetabular fracture) or lumbar drain will also be recruited. 3. Healthy able bodied control volunteer subjects.

Exclusion Criteria:

Subjects under 19 and over 55 years of age; subjects with symptomatic cardiovascular disease or problems, any unstable medical/psychiatric condition or substance abuse that is likely to affect their ability to complete the study. Individuals with SCI and active medical issues such as pressure sores, urinary tract infections, hypertension or heart disorders will be excluded from the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00175773

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Canada, British Columbia
Vancouver General Hospital, Echeleon Bldg.
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
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Principal Investigator: Andrei Krassioukov, MD University of British Columbia

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Responsible Party: Andrei Krassioukov, Principal Investigator, University of British Columbia Identifier: NCT00175773    
Other Study ID Numbers: C04-0374
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Keywords provided by Andrei Krassioukov, University of British Columbia:
Orthostatic stress
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Orthostatic Intolerance
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Primary Dysautonomias
Autonomic Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms