Sildenafil for Cerebrovascular Dysfunction in Chronic Traumatic Brain Injury. (NCT01762475) | Clinical Trial Compass
CompletedPhase 2
Sildenafil for Cerebrovascular Dysfunction in Chronic Traumatic Brain Injury.
United States59 participantsStarted 2013-01
Plain-language summary
The purpose of this study is to determine whether sildenafil (Viagra®) is effective in improving cerebral blood flow and cerebrovascular reactivity inpatients who have persistent symptoms at least 6 months after a traumatic brain injury (TBI).
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Age 18 - 55 years, inclusive
✓. Ability to undergo MRI scanning.
✓. Ability to read, write, and speak English.
✓. Stable doses of concomitant medications for at least 2 weeks prior to enrollment.
✓. Likelihood of completing 18 weeks of study procedures. Likelihood of ability to complete the study procedures means that the person has 1) a low probability of being deployed during the 18-week period 2) verbalizes intent to complete the study.
✓. A history of having sustained a TBI \> 6 months and \< 10 years prior to enrollment. Evidence will be any one of the following 3 criteria:
✓. GCS 3 - 12 (GCS obtained in Emergency Room and noted in medical record)
✓. Post-traumatic amnesia \> 24 hours
Exclusion criteria
✕. Persistent post-concussive symptoms, according to the DSM-IV Research Criteria for Post-Concussional Disorder, including:
✕. Evidence from neuropsychological testing of difficulty in attention or memory. (refers to neuropsychological testing done as a part of the patient's hospital or rehabilitation care not as a part of screening for this study)
✕. Three or more of the following symptoms, which started shortly after the trauma and persist for at least three months:
What they're measuring
1
Cerebrovascular reactivity
Timeframe: 24 months
Trial details
NCT IDNCT01762475
SponsorUniformed Services University of the Health Sciences