Treatment of Orthostatic Hypotension in SCI

Study Overview
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Brief Summary
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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.

Official Title
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Treatment of Orthostatic Hypotension in Individuals With Spinal Cord Injury

Conditions
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Hypotension

Intervention / Treatment
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* Drug: Midodrine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study 1<br>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<br>* Determine best drug and dose to increase and stabilize SBP during orthostatic tilt<br>* Other names: Droxidopa;|
| Experimental: Study 2<br>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<br>* Determine best drug and dose to increase and stabilize SBP during orthostatic tilt<br>* Other names: Droxidopa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | determine differences in systolic blood pressure after midodrine, droxidopa, compression stockings and placebo | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral blood flow velocity | determine differences in cerebral blood flow velocity after midodrine, droxidopa, compression stockings and placebo | 3 years | 
| Symptoms of autonomic dysreflexia and orthostatic hypotension | determine differences in symptoms after midodrine, droxidopa, compression stockings and placebo | 3 years |