Treatment of Orthostatic Hypotension in SCI

Purpose

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.

Condition

  • Hypotension

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • traumatic spinal cord injury - at least 12 months post injury - injury level of C1-T6 - AIS A, B or C - non-ambulatory - non-ventilator

Exclusion Criteria

  • Active psychiatric disorder - Stroke or cerebrovascular disease - Alzheimer's Disease or dementia - Unmanaged cardiac arrhythmias - Concurrent systemic, hepatic, or renal disease - Suspected or diagnosed malignancy - Neurological disease other than SCI - Self-reported history of three or more symptomatic episodes of AD per day

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Midodrine Hydrochloride
    Determine best drug and dose to increase and stabilize SBP during orthostatic tilt
    Other names:
    • Droxidopa
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.
  • Drug: Midodrine Hydrochloride
    Determine best drug and dose to increase and stabilize SBP during orthostatic tilt
    Other names:
    • Droxidopa

Recruiting Locations

Kessler Foundation
West Orange, New Jersey 07052
Contact:
Matthew T Maher, MS
201-566-0291
MMaher@Kesslerfoundation.org

James J Peters VA Medical Center
The Bronx, New York 10468
Contact:
Dylan C Arnero, MA
718-584-9000
dylan.arnero@va.gov

More Details

Status
Recruiting
Sponsor
James J. Peters Veterans Affairs Medical Center

Study Contact

Matt T Maher, MS
9733243588
matthew.maher@va.gov