An observational study in Traumatic Brain Injury, sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Wake Forest University Health Sciences · Observational
Among 10 studies in Brain Injuries, Traumatic by Wake Forest University Health Sciences — 2 open to participants now, 2 under way, none of them phase 3. Brain Injuries, Traumatic · Wake Forest University Health Sciences.
Among the 10 studies in Brain Injuries, Traumatic by Wake Forest University Health Sciences, this one is the only one that started in 2024, is one of 3 observational ones, and was the 9th registered.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 169 is above the median of 117 across 557 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →2 of the 10 studies in Brain Injuries, Traumatic by Wake Forest University Health Sciences are open now, in 1 country. Each count lists the studies.
Of the 281 Brain Injuries, Traumatic studies recruiting now, 120 (43%) set no upper age limit and 119 (42%) stop at 75 or younger; 40 take children under 18; 52 take healthy volunteers.
This study: Up to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2024.
Median enrollment 165 across the 7 interventional studies, 147 across the 3 observational. Of the 7 that completed or were terminated, 4 (57%) have results posted.
Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
2 of the studies in Brain Injuries, Traumatic by Wake Forest University Health Sciences that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06697808Wake Forest University Health SciencesCranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics | 2027-04 |
| NCT06866691Wake Forest University Health SciencesSeizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide | 2027-04 |
Among the 10 studies in Brain Injuries, Traumatic by Wake Forest University Health Sciences, from their registry updates:
Nothing recorded among them since 2026-09-25.
To improve patient selection for head CT, a safe and high sensitivity screening neuroimaging modality is needed. Currently many clinicians must make treatment decisions based solely on the patients clinical exam, which has low sensitivity and specificity and low inter-rater reliability. This study is being done to learn more about B-mode cranial point-of-care ultrasound (cPOCUS). Ultrasound has several advantages. It is a safe, non- invasive, low-cost, fast and portable bedside tool without ionizing radiation exposure.
B-mode cranial point-of-care ultrasound (cPOCUS) being used in this study is an innovative, low-risk, inexpensive solution for diagnosing clinically significant intracranial pathology in children presenting with blunt head trauma which could be valuable for resource- austere environments. Traumatic brain injury remains a leading cause of death and disability in children. In addition, those who present with suspected acute brain injury in resource-austere environments may be at high risk of long-term neurologic sequelae or death. Early neuroimaging to identify traumatic brain injury and guide interventions is key to preventing their neurologic morbidity and mortality.
Pediatric patients in the Emergency Department or Pediatric Intensive Care Unit due blunt head trauma.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diagnostic Accuracy of Cranial Point-of-Care Ultrasound
The diagnostic accuracy of cranial point-of-care ultrasound (cPOCUS) is reported reported by comparing the counts of positive and negative findings for the two imaging modalities with sensitivity, specificity, positive predictive value and negative predictive value.
Time frame: Day 1
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Apr 2027, 29 months after the start.
Of 228 non-industry observational studies under Brain Injuries, Traumatic, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 95. This study's planned 29 months is below that.
Counting every sponsor, half of 250 studies reached it within 49 months; a quarter within 23 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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