Automated Robotic TCD in Traumatic Brain Injury
Launched by VIRGINIA COMMONWEALTH UNIVERSITY · Apr 27, 2023
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called "Automated Robotic TCD in Traumatic Brain Injury," is looking at a new way to monitor brain function in critically ill patients who have suffered severe brain injuries. The goal is to see if using a robotic device for a type of monitoring called Transcranial Doppler (TCD) is safe and effective for patients with serious brain injuries. Researchers will conduct this study at different hospitals that have varying levels of experience with TCD technology to understand how well it works in different settings.
To participate in this trial, patients must be adults aged 18 and older who have experienced a blunt traumatic brain injury and have a low Glasgow Coma Score (GCS of 8 or less), indicating a severe level of consciousness impairment. They should be enrolled within 72 hours of their injury, and their medical team should be able to use the TCD device properly. However, patients with certain conditions, such as a very poor prognosis or specific types of spinal injuries, will not be eligible. Participants in the study can expect to have their brain function monitored over an extended period using this robotic device, which could help improve care for future patients with similar injuries.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adults ≥18
- • Blunt TBI with Glasgow Coma Score (GCS) ≤8
- • Injury within 72 hours
- • Adequate TCD windows
- • Ability to obtain informed consent from a Legally Authorized Representative (LAR)
- Exclusion Criteria:
- • Catastrophic brain injury with grim prognosis (e.g.: GCS 3 with bilateral mid-position pupil)
- • C- spine fracture with evidence of spinal cord injury
- • Severe skull or scalp injury precluding device placement
- • Planned decompressive hemicraniectomy
- • Continuous fever for \>6 hours at the time of enrollment (despite treatment)
- • Lack of TCD window
About Virginia Commonwealth University
Virginia Commonwealth University (VCU) is a prominent academic institution and research leader located in Richmond, Virginia. Renowned for its commitment to advancing healthcare through innovative research and education, VCU plays a pivotal role in clinical trials aimed at improving patient outcomes and understanding complex health issues. The university boasts a collaborative environment, leveraging its diverse faculty expertise and state-of-the-art facilities to conduct rigorous clinical research across various medical disciplines. VCU's dedication to ethical research practices and community engagement ensures that its clinical trials are designed to address critical health challenges while prioritizing participant safety and well-being.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Richmond, Virginia, United States
Davis, California, United States
Winston Salem, North Carolina, United States
Patients applied
Trial Officials
Shraddha Mainali
Principal Investigator
Virginia Commonwealth University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported