Automated Extracranial Internal Carotid Artery Ultrasound Sensor for Traumatic Brain Injury

NCT03482206 | Withdrawn

• 1 other identifier: HUM00137659
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Traumatic brain injury (TBI) affects 1.7 million people in the United States each year, resulting in 2.5 million emergency department visits, 280,000 hospitalizations, \>50,000 deaths, and more than $60 billion in economic cost. TBI also affects \>30,000 military personnel annually and almost 8% of veterans who received care between 2001 and 2011. Post-traumatic neurologic outcome depends on the severity of initial injuries and the extent of secondary cerebral damage. Ischemia is the most common and devastating secondary insult. Ischemic brain damage has been identified histologically in \~90% of patients who died following closed head injury, and several studies have associated low cerebral blood flow (CBF) with poor outcome. Specifically, CBF of less than 200 ml/min has been shown to be the critical lower threshold for survival in neurointensive care patients. In addition to intracranial hypertension and cerebral edema, systemic hypotension and reduced cardiac output contribute substantially to posttraumatic cerebral ischemia. Additionally, the carotid artery is the most common site of blunt cerebral vascular injury (BCVI), which may further compromise CBF and cause subsequent death or debilitating stroke. Specifically, high grade internal carotid arterial (ICA) injuries are associated with the highest mortality and stroke rate. The investigators' goal is to develop of a wearable noninvasive, continuous, automated ultrasound sensor to accurately measure extracranial ICA flow volume. In doing so, the investigators aim to enable early detection of CBF compromise, thereby preventing secondary ischemic injuries in TBI patients. To achieve this goal, the investigators plan to first build a prototype wearable ICA ultrasound senor with integrated signal processing platform, then test its accuracy in an in vitro system and healthy human subjects.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Internal carotid artery blood flow

  The investigators will measure volume of blood flow through the extracranial internal carotid artery using the ultrasound sensor and MRI

  5 minutes before ultrasound or MRI measurement until 15 minutes after the measurement

Secondary Outcomes (1)

• End tidal CO2 level

  5 minutes before ultrasound or MRI measurement until 15 minutes after the measurement

Study Arms (1)

Healthy subjects

EXPERIMENTAL

Healthy adult volunteers (age 18 or greater) that are not claustrophobic, do not have hyperventilation or panic disorders, not pregnant, have no metal implants and can pass the MRI screening questions.

Device: Automated extracranial internal carotid artery ultrasound sensor

Interventions

Automated extracranial internal carotid artery ultrasound sensor DEVICE

The investigators' goal is to develop a wearable noninvasive, continuous, automated ultrasound sensor to accurately measure arterial blood flow volume outside of the head. Ultrasound uses sound waves to create a picture. In doing so, the investigators hope to detect CBF compromise early, preventing secondary injuries in TBI patients.

Healthy subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers
• Age 18 or older

You may not qualify if:

• Claustrophobic
• Hyperventilation or panic disorders
• Pregnant
• Have metal implants or cannot pass the MRI screening questions

Sponsors & Collaborators

• University of Michigan: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 29, 2018
• Study Start: January 1, 2019
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: August 19, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share