Treatment of Orthostatic Hypotension in SCI

NCT05839652 — Phase 4, Recruiting, 25 participants, James J. Peters Veterans Affairs Medical Center

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Treatment of Orthostatic Hypotension in Individuals With Spinal Cord Injury

Registry	NCT05839652, acronym SCI
Status	Recruiting
Phase	Phase 4
Study type	Interventional; randomized, single group, masking: single, treatment
Enrollment	25 (Estimated)
Sponsor	James J. Peters Veterans Affairs Medical Center (Fed); collaborators: Kessler Foundation
Conditions	Hypotension
Interventions	Midodrine Hydrochloride (Drug)
Dates	start 2023-07-01, primary completion 2027-06-30 (estimated), completion 2027-06-30 (estimated), first posted 2023-05-03, last updated 2026-08-10
Locations	2 sites in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Study 1	Experimental	Drug: Midodrine Hydrochloride	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.
Study 2	Experimental	Drug: Midodrine Hydrochloride	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.

Midodrine Hydrochloride (Drug), also known as Droxidopa: Determine best drug and dose to increase and stabilize SBP during orthostatic tilt

+Outcome measures

Primary outcomes

Systolic blood pressure [3 years]: determine differences in systolic blood pressure after midodrine, droxidopa, compression stockings and placebo

Secondary outcomes

Cerebral blood flow velocity [3 years]: determine differences in cerebral blood flow velocity after midodrine, droxidopa, compression stockings and placebo
Symptoms of autonomic dysreflexia and orthostatic hypotension [3 years]: determine differences in symptoms after midodrine, droxidopa, compression stockings and placebo

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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

+Locations (2)

Facility	City	Country	Status
Kessler Foundation	West Orange, New Jersey	United States	Recruiting
James J Peters VA Medical Center	The Bronx, New York	United States	Recruiting

+Study documents

Informed Consent Form (PDF, 2024-02-26)