RECRUITING

Automated Robotic TCD in Traumatic Brain Injury

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

Automated Robotic TCD in Traumatic Brain Injury (ART-TBI)

Quick Facts

Study Start:2025-06-30
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05848297

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults ≥18
  2. * Blunt TBI with Glasgow Coma Score (GCS) ≤8
  3. * Injury within 72 hours
  4. * Adequate TCD windows
  5. * Ability to obtain informed consent from a Legally Authorized Representative (LAR)
  1. * Catastrophic brain injury with grim prognosis (e.g.: GCS 3 with bilateral mid-position pupil)
  2. * C- spine fracture with evidence of spinal cord injury
  3. * Severe skull or scalp injury precluding device placement
  4. * Planned decompressive hemicraniectomy
  5. * Continuous fever for \>6 hours at the time of enrollment (despite treatment)
  6. * Lack of TCD window

Contacts and Locations

Study Contact

Shraddha Mainali, MD
CONTACT
(804) 828-5269
shraddha.mainali@vcuhealth.org
Matthew Ridder
CONTACT
(804) 828-5269
matthew.ridder@vcuhealth.org

Principal Investigator

Shraddha Mainali
PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University

Study Locations (Sites)

University of California, Davis
Davis, California, 95616
United States
Wake Forest University
Winston-Salem, North Carolina, 27109
United States
Virginia Commonwealth University
Richmond, Virginia, 23284
United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

  • Shraddha Mainali, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-30
Study Completion Date2025-09

Study Record Updates

Study Start Date2025-06-30
Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

  • Brain Injuries, Traumatic