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Trial record 27 of 318 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

Automated Extracranial Internal Carotid Artery Ultrasound Sensor for Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT03482206
Recruitment Status : Not yet recruiting
First Posted : March 29, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Cindy Hsu, University of Michigan

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.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Device: Automated extracranial internal carotid artery ultrasound sensor Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Automated Extracranial Internal Carotid Artery Ultrasound Sensor for Traumatic Brain Injury
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy subjects
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
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.




Primary Outcome Measures :
  1. Internal carotid artery blood flow [ Time Frame: 5 minutes before ultrasound or MRI measurement until 15 minutes after the measurement ]
    The investigators will measure volume of blood flow through the extracranial internal carotid artery using the ultrasound sensor and MRI


Secondary Outcome Measures :
  1. End tidal CO2 level [ Time Frame: 5 minutes before ultrasound or MRI measurement until 15 minutes after the measurement ]
    End tidal carbon dioxide level during normal, hypoventilation, and hyperventilation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Age 18 or older

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482206


Contacts
Contact: Cindy H Hsu, MD, PhD 734-936-5947 hcindy@med.umich.edu
Contact: Amanda Pennington, MS 734-936-5947 amanpenn@med.umich.edu

Sponsors and Collaborators
University of Michigan

Responsible Party: Cindy Hsu, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03482206     History of Changes
Other Study ID Numbers: HUM00137659
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System