Phase 3
Completed N=19
Blood Pressure, Cerebral Blood Flow and Cognition in Spinal Cord Injury
Source: ClinicalTrials.gov NCT02307565 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Systolic Blood Pressure — 116.3; 98.0 mmHg
◆ Published Evidence
Emerging
18citations · ~3 / year
Double-blinded, placebo-controlled crossover trial to determine the effects of midodrine on blood pressure during cognitive testing in persons with SCI.
Summary
Following spinal cord injury autonomic regulation of the cardiovascular system is impaired, which results in a variety of measurable abnormalities in blood pressure. Evidence of causality has been documented in the general medical literature with findings of improved cognitive function following acute increases in blood pressure using the anti-hypotensive agent Midodrine Hydrochloride (midodrine). Additionally, a recent report documented an inverse association between blood pressure and depression suggesting that low blood pressure may confer greater risk than high blood pressure. Midodrine is a drug approved by the Food and Drug Administration to treat low blood pressure in the general population. Midodrine is not approved in the United States to treat low blood pressure in persons with spinal cord injury. Therefore, its use in this study is investigational. The first objective is to characterize the relationship between blood pressure, cerebral blood flow velocity and cognitive function after a single dose of midodrine compared to placebo. Second objective is to determine the long-term safety and efficacy of midodrine administration.
Linked Publications (2)
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Double-blinded, placebo-controlled crossover trial to determine the effects of midodrine on blood pressure during cognitive testing in persons with SCI.
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Prolonged Targeted Cardiovascular Epidural Stimulation Improves Immunological Molecular Profile: A Case Report in Chronic Severe Spinal Cord Injury.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systolic Blood Pressure |
116.3; 98.0 | — |
| SECONDARY Cerebral Blood Flow |
45.08; 43.97 | — |
| SECONDARY Hopkins Verbal Learning Test |
-3.56; -2.27 | — |
| SECONDARY Number of Hypertensive Events |
112; 50 | — |
Eligibility Criteria
Inclusion Criteria
Spinal Cord Injured
- Between the ages of 18-65 years old.
- Level of injury is between C1-T12
- Primarily wheelchair dependent for ambulation
- Have a spinal cord injury that is ASIA Impairment Scale (AIS) grade of A, B or C
- Injury occurred more than 1 year ago
- Low blood pressure (Systolic BP less than 110 mmHg for males, Systolic BP less than 100 mmHg for females)
- Primary language is English
- I am right handed
Exclusion Criteria
- Currently have an illness or infection
- Severe history of AD (more than 3 symptomatic events per week, evidence of blood pressure elevations above 140/90 mmHg,significant adverse subjective symptoms reporting)
- Hypertension or diabetes
- History of Traumatic Brain Injury (TBI)
- Neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.)
- History of epilepsy or other seizure disorder
- Diagnosis of a psychiatric disorder such as post-traumatic stress disorder, schizophrenia or bipolar disorder
- Within the past 6 months, abused illicit drugs
- Pre-screen mini mental status exam score of less than 24, as rated by the researcher
- Vision is impaired- more than 20/60 in worst eye (with prescription eyewear)
- Coronary heart and/or artery disease
- Major surgery in the last 30 days
- Pregnant
Data sourced from ClinicalTrials.gov (NCT02307565) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.