Automated robotic monitoring of blood flow in traumatic brain injury patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the safety, feasibility, and efficacy of prolonged automated robotic transcranial Doppler (TCD) monitoring in critically ill patients suffering from severe traumatic brain injury (TBI). Participants will undergo daily monitoring sessions lasting up to 4 hours for a minimum of 3 days, utilizing a robotic TCD system that continuously records cerebral blood flow velocity in the middle cerebral artery. The study will also gather feedback from healthcare providers regarding the implementation of this monitoring protocol. The goal is to determine whether this technology can provide meaningful clinical data while ensuring patient safety.

Why it matters

Who can join: the full rules

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

Where it's running

• Virginia Commonwealth University
  Richmond, Virginia, United States Recruiting
• University of California, Davis
  Davis, California, United States Not yet recruiting
• Wake Forest University
  Winston-Salem, North Carolina, United States Not yet recruiting

Study contacts

• Principal investigator: Shraddha Mainali — Virginia Commonwealth University
• Study coordinator: Shraddha Mainali, MD
• Email: shraddha.mainali@vcuhealth.org
• Phone: (804) 828-5269

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.