Recruiting

Robotic TCD

Sponsor:

Virginia Commonwealth University

Code:

NCT05848297

Conditions

Brain Injuries, Traumatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcranial Doppler ultrasonography (TCD)

Study Details

Brief 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

Conditions

Brain Injuries, Traumatic

Study ID

NCT05848297

Start date

May 20, 2025

Status verified date

Jun, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Prolonged automated TCD

Interventions

Transcranial Doppler ultrasonography (TCD)

Portable, bedside, non-invasive diagnostic tool used for real-time assessment of cerebral hemodynamics

Primary outcome measure

  • Patient discomfort (per discretion of the bedside nurse) [ Time Frame: 2 years ]
  • Inadvertent dislodgement of other intracranial monitoring device/s (if present) [ Time Frame: 2 years ]
  • Skin changes associated with TCD [ Time Frame: 2 years ]
  • Provider feedback on safety of prolonged automated robotic TCD monitoring in severe TBI population. [ Time Frame: 2 years ]
  • Evaluation of adequate temporal windows [ Time Frame: 2 years ]
  • Evaluation of adequate insolation of middle cerebral arteries (MCA) [ Time Frame: 2 years ]
  • Provider feedback on the feasibility of prolonged automated robotic TCD monitoring in severe TBI population [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Shraddha Mainali, MD

(804) 828-5269shraddha.mainali@vcuhealth.org

Matthew Ridder

(804) 828-5269matthew.ridder@vcuhealth.org

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23284

Contacts

Shraddha Mainali, MD

804-828-5269Shraddha.Mainali@vcuhealth.org

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-06-03.