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NCT Number: NCT05839652

Treatment of Orthostatic Hypotension in SCI

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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Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kessler Foundation, West Orange, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Midodrine hydrochloride

Drug

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

Other names: Droxidopa

Primary outcomes

  1. Systolic blood pressure

    Time frame: 3 years

    determine differences in systolic blood pressure after midodrine, droxidopa, compression stockings and placebo

Secondary outcomes

  1. Cerebral blood flow velocity

    Time frame: 3 years

    determine differences in cerebral blood flow velocity after midodrine, droxidopa, compression stockings and placebo

  2. Symptoms of autonomic dysreflexia and orthostatic hypotension

    Time frame: 3 years

    determine differences in symptoms after midodrine, droxidopa, compression stockings and placebo

Study contacts

Contact information is provided by the study sponsor or research team.

Matt G. Maher, MS

CONTACT

[email protected]

9733243588

Sponsors and collaborators

Lead sponsor

James J. Peters Veterans Affairs Medical Center

Fed

Collaborators

  • Kessler Foundation

Registry information

Official study title

Treatment of Orthostatic Hypotension in Individuals With Spinal Cord Injury

Acronym: SCI

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 3, 2023
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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