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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.