NCT05848297 · Virginia Commonwealth University
Automated Robotic TCD in Traumatic Brain Injury
(ART-TBI)
What this study is about
This study's objective is to determine the safety, feasibility and effectiveness of prolonged automated robotic TCD monitoring in critically ill patients with severe TBI across multiple clinical sites with varying levels of TCD availability and experience
View original scientific description
This study's objective is to determine the safety, feasibility and efficacy of prolonged automated robotic TCD monitoring in critically ill patients with severe TBI across multiple clinical sites with varying levels of TCD availability and experience
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Davis, California
- Winston-Salem, North Carolina
- Richmond, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations