RecruitingPhase 4NCT05839652

Treatment of Orthostatic Hypotension in SCI

Treatment of Orthostatic Hypotension in Individuals With Spinal Cord Injury


Sponsor

James J. Peters Veterans Affairs Medical Center

Enrollment

25 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria6

  • 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 Criteria8

  • 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

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Interventions

DRUGMidodrine Hydrochloride

Determine best drug and dose to increase and stabilize SBP during orthostatic tilt


Locations(2)

Kessler Foundation

West Orange, New Jersey, United States

James J Peters VA Medical Center

The Bronx, New York, United States

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NCT05839652


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