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NCT04058132 · ClinicalTrials.gov registry record · Phase 2
Cerebrovascular Reactivity Assessed With fNIRS as a Biomarker of TCVI After Acute Traumatic Brain Injury in Military
A Phase 2 study, sponsored by Uniformed Services University of the Health Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT04058132: Clinical Trial Phase 2 study, sponsored by Uniformed Services University of the Health Sciences.
NCT04058132 is a Phase 2 study that was terminated before completion, run by Uniformed Services University of the Health Sciences. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04058132, a Phase 2 study, was terminated before completion, sponsored by Uniformed Services University of the Health Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
The study includes people who have recently had a traumatic brain injury (TBI) and healthy controls who have not had a TBI and is designed to measure brain blood flow serially after a TBI. Studies have shown that small blood vessels in the brain may be injured during a TBI. The goal is to learn about brain blood vessel function from as early as the first week to 6 months after a TBI . The study uses Near Infrared Spectroscopy (NIRS) which uses small lights that detect oxygen levels in the blood, measuring blood flow in the brain. This is compared with magnetic resonance imaging (MRI). When blood flow increases in the brain in response to a stimulus, this is called cerebral vascular reactivity (CVR). The study aims to learn about CVR using a few minutes of special breathing similar to breath holding while in an MRI (magnetic resonance imaging), and CVR measures after one dose of a common drug called sildenafil (generic Viagra) 50 mg taken once during CVR measurements at each of up to 4 visits. The investigators will measure CVR at different times during a 6-month period in participants who have had a TBI to see how CVR measures and blood vessels function during the first 6 months after a brain injury.
Primary Outcome
This is a pilot study, whose primary aim is to obtain pilot data that can be used to design a carefullypowered Phase III clinical trial. Thus, a power analysis is only an approximation.This compares favorably with the effect size of 1.3 noted in our preliminary study in chronic TBI (Figs. 2 and 4). For the observed effect size of 1.3, power will be 90%. Since we anticipate that the reduction in CVR will be greater in the acute period than in the chronic period, the proposed study has adequate sa
Interventions
- DRUG Sildenafil Citrate 50Mg Tab
- DEVICE functional Near-infrared Spectroscopy (fNIRS)
- OTHER Carbon Dioxide (CO2) 5%
- OTHER Neuropsychological Assessments
- DRUG Gadolinium contrast infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-08-09 |
| Est. Completion | 2020-03-01 |
| Phase | Phase 2 |
Why NCT04058132 stopped before completion
NCT04058132 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which Sildenafil Citrate 50Mg Tab is the first listed.
NCT04058132 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04058132 about?
NCT04058132 is a clinical study titled "Cerebrovascular Reactivity Assessed With fNIRS as a Biomarker of TCVI After Acute Traumatic Brain Injury in Military". The study includes people who have recently had a traumatic brain injury (TBI) and healthy controls who have not had a TBI and is designed to measure brain blood flow serially after a TBI. Studies have shown that small blood vessels in the brain may be injured during a TBI. The goal is to learn abou...
What is the current status of trial NCT04058132?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2019-08-09. Estimated completion is 2020-03-01.
What interventions are being tested in trial NCT04058132?
The interventions under investigation include: Sildenafil Citrate 50Mg Tab (DRUG), functional Near-infrared Spectroscopy (fNIRS) (DEVICE), Carbon Dioxide (CO2) 5% (OTHER), Neuropsychological Assessments (OTHER), Gadolinium contrast infusion (DRUG).
Who is sponsoring clinical trial NCT04058132?
This trial is sponsored by Uniformed Services University of the Health Sciences, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04058132's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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