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Search / Trial NCT05848297

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.

Locations

Richmond, Virginia, United States

Davis, California, United States

Winston Salem, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Shraddha Mainali

Principal Investigator

Virginia Commonwealth University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported