Recruiting

Cranial Ultrasound

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06697808

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Traumatic Brain Injury

Study ID

NCT06697808

Start date

Nov 24, 2024

Status verified date

Aug, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients requiring a head computed tomography (CT) or brain MRI as the standard of care
  • Seen in the pediatric Emergency Department or Pediatric Intensive Care Unit at Atrium Health Wake Forest Brenner Children's Hospital or Levine Children's Hospital

Exclusion Criteria:

  • Patients with open skull fractures
  • Previous hemicraniectomy
  • Existing surgical defect in the skull
  • Patients being transitioned to comfort care

Study Design

Enrollment

169 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Diagnostic Accuracy of Cranial Point-of-Care Ultrasound [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Denise Fraga, MD

704-355-3181Denise.Fraga@advocatehealth.org

Locations

Atrium Health Carolinas Medical Center

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Denise Fraga, MD

704-355-3181Denise.Fraga@advocatehealth.org

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • head injury
  • imaging
  • pediatrics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-08-24.