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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04058132
The ClinicalTrials.gov registry entry for NCT04058132 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Uniformed Services University of the Health Sciences, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Sildenafil Citrate 50Mg Tab is the first listed.
NCT04058132 reports 0 study locations.
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.
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