Treatment of Orthostatic Hypotension in SCI

James J. Peters Veterans Affairs Medical Center

Status and phase: Enrolling; Phase 4

Conditions: Hypotension

Treatments: Drug: Midodrine Hydrochloride

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05839652

1747301-1

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Study 1

Experimental group

Description:

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.

Treatment:

Drug: Midodrine Hydrochloride

Study 2

Experimental group

Description:

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.

Treatment:

Drug: Midodrine Hydrochloride