Treatment of Orthostatic Hypotension in SCI

Phase 4

Recruiting

• Conditions: Hypotension
• Interventions: Drug: Midodrine Hydrochloride

• Registration Number: NCT05839652
• Lead Sponsor: James J. Peters Veterans Affairs Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-20
• Study First Submitted QC: 2023-04-20
• Study First Posted: 2023-05-03
• Study Start: 2023-07-01
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study 1	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	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.

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure	3 years	determine differences in systolic blood pressure after midodrine, droxidopa, compression stockings and placebo

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Kessler Foundation; 🇺🇸 West Orange, New Jersey, United States

James J Peters VA Medical Center; 🇺🇸 Bronx, New York, United States