Treatment of Orthostatic Hypotension in SCI (SCI)

February 29, 2024 updated by: Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center

Treatment of Orthostatic Hypotension in Individuals With Spinal Cord Injury

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • West Orange, New Jersey, United States, 07052
    • New York
      • Bronx, New York, United States, 10468
        • Recruiting
        • James J Peters VA Medical Center
        • Principal Investigator:
          • Jill M Wecht, EdD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study 1
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.
Drug: Midodrine Hydrochloride
Determine best drug and dose to increase and stabilize SBP during orthostatic tilt
Other Names:
  • Droxidopa
Experimental: Study 2
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.
Drug: Midodrine Hydrochloride
Determine best drug and dose to increase and stabilize SBP during orthostatic tilt
Other Names:
  • Droxidopa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: 3 years
determine differences in systolic blood pressure after midodrine, droxidopa, compression stockings and placebo
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral blood flow velocity
Time Frame: 3 years
determine differences in cerebral blood flow velocity after midodrine, droxidopa, compression stockings and placebo
3 years
Symptoms of autonomic dysreflexia and orthostatic hypotension
Time Frame: 3 years
determine differences in symptoms after midodrine, droxidopa, compression stockings and placebo
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

James J. Peters Veterans Affairs Medical Center

Collaborators

Kessler Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1747301-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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