Brain Injuries, TraumaticART-TBINCT05848297
Automated Robotic TCD in Traumatic Brain Injury
An observational study of Brain Injuries, Traumatic, run by Virginia Commonwealth University at 3 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Transcranial Doppler ultrasonography (TCD)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 May 2025to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients with severe blunt head trauma with GCS ≤8 within 72 hours of brain injury will be included. Unstable patients and those without identifiable TCD windows will be excluded.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
University of California, Davis
Davis, California, 95616
Jeffrey Robert Vitt, MD, jrvitt@ucdavis.edu
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23284
Shraddha Mainali, MD, 804-828-5269, Shraddha.Mainali@vcuhealth.org
- Not yet recruiting
Wake Forest University
Winston-Salem, North Carolina, 27109
Aarti Sarwal, MD, asarwal@wakehealth.edu
About this study
Official title: Automated Robotic TCD in Traumatic Brain Injury (ART-TBI)
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
Read the detailed description
Upon informed consent, patients will undergo daily automated robotic TCD monitoring sessions for up to 4 hours a day for a total duration of at least 3 days and up to 5 days whenever clinically feasible. TCD monitoring of bilateral middle cerebral artery cerebral blood flow velocity (MCA CBFV) will be performed using a robotic TCD system equipped with bilateral 2-MHz Doppler probes. This system allows for continuous bilateral extended duration recording of MCA CBFV, using robotically controlled TCD probes that allow automated angle correction to maintain optimal MCA insonation.
Safety measures: patient discomfort, device dislodgement or skin lesion at the site of insonation Feasibility: feasibility of using bilateral automated robotic TCD monitoring device on severe TBI patients for >= 4 hrs per day that can provide clinically useful/meaningful data for over 50% of the total monitoring period
Additionally, a 5-question provider survey will be administered at each participating site to obtain bedside nurse and clinician feedback on the perceived safety and feasibility of protocol implementation.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Transcranial Doppler ultrasonography (TCD)
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Doppler ultrasonography (TCD)Device
Portable, bedside, non-invasive diagnostic tool used for real-time assessment of cerebral hemodynamics
| Study group | Role | What they receive |
|---|---|---|
| Prolonged automated TCD | Not described Receives: Device: Transcranial Doppler ultrasonography (TCD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient discomfort (per discretion of the bedside nurse)
To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Bedside nurse will describe
Measured: 2 years
Inadvertent dislodgement of other intracranial monitoring device/s (if present)
To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Provider filling out form will describe
Measured: 2 years
Skin changes associated with TCD
To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Provider filling out form will describe
Measured: 2 years
Provider feedback on safety of prolonged automated robotic TCD monitoring in severe TBI population.
A 5-question provider survey will be administered at each participating site to obtain bedside nurse and clinician feedback on the perceived safety of protocol implementation.
Measured: 2 years
Evaluation of adequate temporal windows
To evaluate the feasibility of prolonged automated robotic TCD monitoring in severe TBI population. Provider completing form will describe
Measured: 2 years
Evaluation of adequate insolation of middle cerebral arteries (MCA)
To evaluate the feasibility of prolonged automated robotic TCD monitoring in severe TBI population. Provider completing form will describe
Measured: 2 years
Provider feedback on the feasibility of prolonged automated robotic TCD monitoring in severe TBI population
A 5-question provider survey will be administered at each participating site to obtain bedside nurse and clinician feedback on the perceived feasibility of protocol implementation, as well as other limiting factors. The survey will be in the format of a Likert scale.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start20 May 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University, University of California, Davis
- Responsible party
- Sponsor
- Investigators
- Shraddha Mainali, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848297
- Sponsor's protocol ID
- HM20026297
- Acronym
- ART-TBI
- Status last verified
- Jun 2026
- First submitted
- 29 Mar 2023
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Robotic TCD in Traumatic Brain Injury (ART-TBI)
- ClinicalTrials.gov ID
- NCT05848297
- Acronym / sponsor ID
- ART-TBI / HM20026297
- Conditions
- Brain Injuries, Traumatic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Wake Forest University, University of California, Davis
- Study start
- 20 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Upon informed consent, patients will undergo daily automated robotic TCD monitoring sessions for up to 4 hours a day for a total duration of at least 3 days and up to 5 days whenever clinically feasible. TCD monitoring of bilateral middle cerebral artery cerebral blood flow velocity (MCA CBFV) will be performed using a robotic TCD system equipped with bilateral 2-MHz Doppler probes. This system allows for continuous bilateral extended duration recording of MCA CBFV, using robotically controlled TCD probes that allow automated angle correction to maintain optimal MCA insonation.
Safety measures: patient discomfort, device dislodgement or skin lesion at the site of insonation Feasibility: feasibility of using bilateral automated robotic TCD monitoring device on severe TBI patients for >= 4 hrs per day that can provide clinically useful/meaningful data for over 50% of the total monitoring period
Additionally, a 5-question provider survey will be administered at each participating site to obtain bedside nurse and clinician feedback on the perceived safety and feasibility of protocol implementation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prolonged automated TCD | – | Device: Transcranial Doppler ultrasonography (TCD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with severe blunt head trauma with GCS ≤8 within 72 hours of brain injury will be included. Unstable patients and those without identifiable TCD windows will be excluded.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Doppler ultrasonography (TCD)Portable, bedside, non-invasive diagnostic tool used for real-time assessment of cerebral hemodynamics | Device | Prolonged automated TCD |
Primary outcome
Patient discomfort (per discretion of the bedside nurse)
Time frame: 2 years
To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Bedside nurse will describe
Inadvertent dislodgement of other intracranial monitoring device/s (if present)
Time frame: 2 years
To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Provider filling out form will describe
Skin changes associated with TCD
Time frame: 2 years
To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Provider filling out form will describe
Provider feedback on safety of prolonged automated robotic TCD monitoring in severe TBI population.
Time frame: 2 years
A 5-question provider survey will be administered at each participating site to obtain bedside nurse and clinician feedback on the perceived safety of protocol implementation.
Evaluation of adequate temporal windows
Time frame: 2 years
To evaluate the feasibility of prolonged automated robotic TCD monitoring in severe TBI population. Provider completing form will describe
Evaluation of adequate insolation of middle cerebral arteries (MCA)
Time frame: 2 years
To evaluate the feasibility of prolonged automated robotic TCD monitoring in severe TBI population. Provider completing form will describe
Provider feedback on the feasibility of prolonged automated robotic TCD monitoring in severe TBI population
Time frame: 2 years
A 5-question provider survey will be administered at each participating site to obtain bedside nurse and clinician feedback on the perceived feasibility of protocol implementation, as well as other limiting factors. The survey will be in the format of a Likert scale.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shraddha Mainali principal investigator
Virginia Commonwealth University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic, run by Virginia Commonwealth University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shraddha Mainali, MD ((804) 828-5269, shraddha.mainali@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient discomfort (per discretion of the bedside nurse) (time frame: 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.