Traumatic Brain InjuryNCT03482206
Automated Extracranial Internal Carotid Artery Ultrasound Sensor for Traumatic Brain Injury
A study testing Automated extracranial internal carotid artery ultrasound sensor in people with Traumatic Brain Injury, run by University of Michigan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Automated extracranial internal carotid artery ultrasound sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Age 18 or older
Who cannot join
- Claustrophobic
- Hyperventilation or panic disorders
- Pregnant
- Have metal implants or cannot pass the MRI screening questions
About this study
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
- Being tested
- Automated extracranial internal carotid artery ultrasound sensor
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated extracranial internal carotid artery ultrasound sensorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Automated extracranial internal carotid artery ultrasound sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 minutes before ultrasound or MRI measurement until 15 minutes after the measurement
Secondary outcomes (1)
End tidal CO2 level
End tidal carbon dioxide level during normal, hypoventilation, and hyperventilation
Measured: 5 minutes before ultrasound or MRI measurement until 15 minutes after the measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Jan 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Why it stopped: Need more time to optimize the sensor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cindy Hsu, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482206
- Sponsor's protocol ID
- HUM00137659
- Status last verified
- Aug 2019
- First submitted
- 20 Mar 2018
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Extracranial Internal Carotid Artery Ultrasound Sensor for Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03482206
- Acronym / sponsor ID
- HUM00137659
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Need more time to optimize the sensor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Device: Automated extracranial internal carotid artery ultrasound sensorHealthy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers
- Age 18 or older
Key exclusion criteria (4 listed)
- Claustrophobic
- Hyperventilation or panic disorders
- Pregnant
- Have metal implants or cannot pass the MRI screening questions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated extracranial internal carotid artery ultrasound sensorThe 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. | Device | Healthy subjects |
Primary outcome
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
1 secondary outcome
End tidal CO2 level
Time frame: 5 minutes before ultrasound or MRI measurement until 15 minutes after the measurement
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Automated extracranial internal carotid artery ultrasound sensor in people with Traumatic Brain Injury, run by University of Michigan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal carotid artery blood flow (time frame: 5 minutes before ultrasound or MRI measurement until 15 minutes after the measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.