Treatment options for low blood pressure in individuals with spinal cord injury
Treatment of Orthostatic Hypotension in Individuals With Spinal Cord Injury
This study is testing whether different treatments, including a medication called Midodrine, can help people with spinal cord injuries who have low blood pressure feel better and improve their quality of life.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | James J. Peters Veterans Affairs Medical Center Federal |
| Locations | 2 sites (West Orange, New Jersey and 1 other locations) |
| Trial ID | NCT05839652 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of both non-pharmacological and pharmacological treatments on individuals with spinal cord injury (SCI) who experience orthostatic hypotension. It aims to assess how these interventions impact hemodynamic responses, symptoms of autonomic dysreflexia, and overall levels of fatigue and comfort. The primary pharmacological intervention being tested is Midodrine Hydrochloride, which is known for its potential to raise blood pressure. Participants will be closely monitored to evaluate the effectiveness of these treatments in improving their quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with traumatic spinal cord injuries who are at least 12 months post-injury and experience symptoms of orthostatic hypotension.
Not a fit: Patients with active psychiatric disorders, significant cardiovascular issues, or other serious concurrent medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective treatment options for managing low blood pressure in patients with spinal cord injuries, enhancing their daily functioning and comfort.
How similar studies have performed: While there have been studies on orthostatic hypotension treatments, the specific combination of interventions in this study is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
West Orange, New Jersey and 1 other locations
- Kessler Foundation — West Orange, New Jersey, United States (Recruiting)
- James J Peters VA Medical Center — The Bronx, New York, United States (Recruiting)
Study contacts
- Study coordinator: Matt G. Maher, MS
- Email: matt.maher@va.gov
- Phone: 9733243588
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.