Treatment of Orthostatic Hypotension in SCI

Drug
General health
Online since 20 March 2024, updated 117 days ago

About this trial

This trial is enrolling 25 individuals with chronic cervical/thoracic spinal cord injury for 2 studies on blood pressure. Study 1 will test the effect of midodrine and droxidopa on blood pressure in seated or supine positions. Study 2 compares the use of a compression garment, midodrine, and droxidopa against placebo on blood pressure and other symptoms of blood pressure changes. If included, participants will visit the laboratory on 6 occasions to receive increasing doses of midodrine or droxidopa (study 1). For study 2, the use of compression garments, midropine, or droxidopa will be compared to placebo to assess the effect on blood pressure control, autonomic dysreflexia, orthostatic hypotension, fatigue and thermal comfort. Final assessments will be performed after 3 years.

Included participants

Gender
All
Age
18 - 60 years
Injury level
C1 - T6
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    Time since injury
    ≥ 12 months
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-T6

    What’s involved

    Type

    Drug

    Details

    - Study 1: participants will undergo six sessions where they will receive sequentially increasing doses of midodrine and droxidopa to test the effect on blood pressure in different positions (supine and seated). - Study 2: participants will receive a compression garment, midodrine, droxidopa, or placebo drug to test the effect on blood pressure and other symptoms resulting from changes in blood pressure. - Final testing of blood pressure control, autonomic dysreflexia, orthostatic hypotension, fatigue and thermal comfort will be performed after 3 years.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Jul 2023
    • Organisation
    • James J. Peters Veterans Affairs Medical Center
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Jul 2023
    • Organisation
    • James J. Peters Veterans Affairs Medical Center

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more