Treatment of Orthostatic Hypotension in Individuals With Spinal Cord Injury
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Systolic blood pressure
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- 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
Arms & Interventions
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.
Intervention: Midodrine Hydrochloride (Drug)
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.
Intervention: Midodrine Hydrochloride (Drug)
Outcomes
Primary Outcomes
Systolic blood pressure
Time Frame: 3 years
determine differences in systolic blood pressure after midodrine, droxidopa, compression stockings and placebo
Secondary Outcomes
- Symptoms of autonomic dysreflexia and orthostatic hypotension(3 years)
- Cerebral blood flow velocity(3 years)
Investigators
Jill M. Wecht, Ed.D.
Research Scientist
James J. Peters Veterans Affairs Medical Center