Blood Pressure and Brain Blood Flow Regulation After Midodrine Administration in Those With Spinal Cord Injury

This project aims to evaluate the physiological effects of Midodrine administration during orthostatic challenge in those with high level spinal cord injury. Midodrine has been shown to improve orthostatic symptoms in those with spinal cord injury but the physiological mechanisms influenced have not been identified. The investigators will examine key physiological components influencing orthostatic tolerance. The investigators will do this, by measuring the baroreflex, and brain blood flow autoregulation (the ability to maintain brain blood flow) before during and after the sit-up test. Two sit-up tests will occur; one before Midodrine administration, and one after administration of a 10mg dose of Midodrine.

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Key information

Conditions

Orthostatic Intolerance Autonomic Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Primary Dysautonomias Signs and Symptoms

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GF Strong Hospital and Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To be included in the study, participants must have sustained a traumatic spinal cord injury within the ages of 18-49 years.
Also, participants must have an injury level above the 6th thoracic vertebrae and be a non-smoker for a minimum of one year.

Exclusion criteria

Any participants with a history of cardiovascular disease, pulmonary disease or diabetes mellitus will not be eligible.
Also, participants will not be eligible to take part in study if they experiences acute distress, or are taking medications known to influence cardiovascular function.
Patient will be not eligible for the study if he/she has known adverse reaction to Midodrine.

Treatment and study plan

Midodrine

Drug

Single 10 mg dose

Other names: Amatine, ProAmatine, Gutron

Primary outcomes

Baroreflex sensitivity

Time frame: Immediately after drug administration (30 mins)

Secondary outcomes

Cerebral autoregulation

Time frame: Thirty minutes after administration

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Neural and Mechanical Baroreflex Sensitivity and Cerebral Blood Flow

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Dec 23, 2011
Registry last updated: Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed