- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00175773
Mechanisms of Orthostatic Intolerance in Spinal Cord Injured Individuals and Following Bed Rest
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada
- Vancouver General Hospital, Echeleon Bldg.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrei Krassioukov, MD, University of British Columbia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C04-0374
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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