NCT04515212

Brief Summary

This is a research study to develop a noninvasive test using ultrasound to determine when urgent, life-saving treatment is needed for those with severe traumatic brain injuries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

February 3, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2024

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

3 years

First QC Date

August 13, 2020

Last Update Submit

July 18, 2024

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Optic nerve sheath diameter

    Develop software that will automatically measure optic nerve sheath diameter by analyzing the radio frequency data from an ultrasound probe intervention from those that do not, we will measure the optic nerve sheath diameter manually in the cross-sectional images.

    Approximately 10 minutes at the time of ultrasounds

Study Arms (2)

Healthy Volunteers

ACTIVE COMPARATOR
Other: Optic Nerve Ultrasounds

Traumatic Brain Injury Patients

EXPERIMENTAL
Other: Optic Nerve Ultrasounds

Interventions

Optic Nerve UltrasoundsOTHER

Patients will have up to four ultrasounds of the optic nerve.

Healthy VolunteersTraumatic Brain Injury Patients

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18 or older
  • Able to provide legally effective consent

You may not qualify if:

  • Intracranial disease, neurologic symptoms, or eye pathology
  • Adults age 18 or older
  • Confirmed or suspected severe traumatic brain injury
  • Able to provide legally effective consent
  • Significant bilateral ocular trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Sean Montgomery

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 17, 2020

Study Start

February 3, 2021

Primary Completion

February 7, 2024

Study Completion

February 10, 2024

Last Updated

July 22, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)