Actively Recruiting
Automated Robotic TCD in Traumatic Brain Injury (ART-TBI)
Led by Virginia Commonwealth University · Updated on 2026-06-03
30
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
V
Virginia Commonwealth University
Lead Sponsor
W
Wake Forest University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, feasibility, and effectiveness of prolonged automated robotic transcranial Doppler (TCD) monitoring in critically ill patients with severe traumatic brain injury (TBI). The study aims to assess this technology across multiple clinical sites with varying levels of TCD availability and experience to better understand its clinical utility. Participants will undergo daily sessions of automated robotic TCD monitoring for up to 4 hours each day, for a minimum of 3 days and up to 5 days when possible. The monitoring uses a robotic system with bilateral 2-MHz Doppler probes to continuously record cerebral blood flow velocity in both middle cerebral arteries. This system includes automated angle correction to maintain optimal measurement quality. During the study, participants will be monitored for safety concerns such as discomfort, device dislodgement, and skin changes at the probe site. Feedback will be collected from nurses and clinicians to evaluate safety and feasibility. Researchers will also assess the adequacy of temporal windows and insonation quality of the arteries. The total study duration includes up to 5 days of monitoring with ongoing safety and usability assessments.
CONDITIONS
Brief Title
Automated Robotic TCD in Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Blunt traumatic brain injury with Glasgow Coma Score of 8 or less
- Injury occurred within 72 hours prior to enrollment
- Adequate temporal windows for transcranial Doppler monitoring
- Ability to obtain informed consent from a legally authorized representative
You will not qualify if you...
- Catastrophic brain injury with grim prognosis (e.g., Glasgow Coma Score 3 with bilateral mid-position pupil)
- Cervical spine fracture with evidence of spinal cord injury
- Severe skull or scalp injury preventing device placement
- Planned decompressive hemicraniectomy
- Continuous fever for more than 6 hours despite treatment at enrollment
- Lack of adequate transcranial Doppler window for monitoring
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 3 days and up to 5 days
Participants undergo daily automated robotic transcranial Doppler (TCD) monitoring sessions to assess cerebral blood flow velocity using a bedside non-invasive device.
Daily monitoring sessions lasting up to 4 hours each
Trial Site Locations
Total: 3 locations
1
University of California, Davis
Davis, California, United States, 95616
Not Yet Recruiting
2
Wake Forest University
Winston-Salem, North Carolina, United States, 27109
Not Yet Recruiting
3
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Actively Recruiting
Research Team
S
Shraddha Mainali, MD
M
Matthew Ridder
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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