CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Midodrine Hydrochloride +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02893553
NCT02893553Phase 2Completed

The Effects of Normalizing Blood Pressure on Cerebral Blood Flow in Hypotensive Individuals With Spinal Cord Injury

James J. Peters Veterans Affairs Medical Center·interventional·Posted Sep 8, 2016·Updated Oct 1, 2024

In Brief

A Phase 2 clinical trial evaluating Midodrine Hydrochloride, Pyridostigmine Bromide, and 2 other interventions for Spinal Cord Injury and 9 related conditions. Completed, enrolled 21 participants across 2 sites.

Detailed Summary

Dysregulation of blood pressure (BP), secondary to decentralized autonomic nervous system (ANS) control of the cardiovascular system, often results in chronic hypotension and orthostatic hypotension (OH) in persons with spinal cord injury (SCI), particularly in those with high cord lesions (i.e., above T6). While most hypotensive individuals with chronic SCI remain asymptomatic and do not complain of symptoms associated with cerebral hypoperfusion, evidence of reduced resting cerebral blood flow (CBF) has been reported in association with low systemic BP in the SCI and non-SCI populations. Reduced CBF in hypotensive individuals may lead to cognitive dysfunction, and we reported significantly impaired memory and marginally impaired attention processing in hypotensive individuals with SCI compared to a normotensive SCI cohort. Furthermore, we found that CBF was not increased during cognitive testing in individuals with SCI, which may contribute to impaired cognitive function compared to non-SCI controls. Although asymptomatic hypotension may have an adverse impact on cognitive function and quality of quality of life (QOL) clinical management of this condition is extremely low. In fact, we reported that while nearly 40% of Veterans with SCI were hypotensive, less than 1% carried the diagnosis of hypotension or were prescribed an anti-hypotensive medication. The discrepancy between incidence and treatment of asymptomatic hypotension in the SCI population may relate to a paucity of treatment options which are supported by rigorous clinical trials documenting safe and effective use of anti-hypotensive therapy on BP, CBF and cognitive function. We hypothesize these study medications may increase systolic blood pressure to the normal range and improve cerebral blood flow velocity. Results and conclusions will not be removed from the record.

Study Details

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 8, 2016
Enrollment StartDec 1, 2016
Primary CompletionDec 1, 2021
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 9.8 years ago

Interventions

Midodrine Hydrochloridedrug

study 1 will be single blind. study 2 will be blinded randomized-control trial.

Pyridostigmine Bromidedrug

study 1 will be single blind. study 2 will be blinded randomized-control trial.

Mirabegrondrug

study 1 will be single blind. study 2 will be blinded randomized-control trial.

Placeboother

placebo will only be used for study arm 2, the randomized blinded phase.