Treatment of Orthostatic Hypotension in Individuals With Spinal Cord Injury
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The purpose of this study is to identify the effects of non-pharmacological and pharmacological anti-hypotensive treatment interventions on orthostatic hemodynamic responses, symptoms of autonomic dysreflexia and orthostatic hypotension, and levels of fatigue and comfort in hypotensive individuals with SCI.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• traumatic spinal cord injury
• at least 12 months post injury
• injury level of C1-T6
• AIS A, B or C
• non-ambulatory
• non-ventilator
Locations
United States
New Jersey
Kessler Foundation
RECRUITING
West Orange
New York
James J Peters VA Medical Center
RECRUITING
The Bronx
Contact Information
Primary
Matt G. Maher, MS
matt.maher@va.gov
9733243588
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 25
Treatments
Experimental: Study 1
Twenty-five participants will be asked to visit the laboratory on 6 occasions, for an open-label, dose escalation trial to determine the effect of midodrine and droxidopa on supine and seated blood pressure and on symptoms of autonomic dysreflexia and orthostatic hypotension.
Experimental: Study 2
Determine the effects of compression garments, midodrine, and droxidopa, compared to placebo, on orthostatic hemodynamics, symptoms of AD and OH and reporting of fatigue and thermal comfort.
Related Therapeutic Areas
Sponsors
Leads: James J. Peters Veterans Affairs Medical Center
Collaborators: Kessler Foundation