30 Participants Needed

Transcranial Doppler Monitoring for Brain Injury

DT
Overseen ByDanyal Thaver
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Various methods have been studied to evaluate autoregulation. However, there is currently no universally accepted technique to assess integrity of the cerebral autoregulation neurovascular system. In the last decade, significant progress has been achieved in developing methods to assess cerebral autoregulation by quantifying cross-correlation between spontaneous oscillations in CBF or oxygenation and similar oscillations in arterial blood pressure.In this study the investigators will analyze the relationship between spontaneous fluctuations in mean arterial blood pressure and cerebral blood flow velocity or cerebral regional oxygenation to investigate two novel methods for measuring cerebral autoregulation, Transfer Function Analysis and Wavelet Coherence after acute pediatric brain injury.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is Transcranial Doppler Monitoring safe for humans?

Transcranial Doppler (TCD) is generally considered safe for humans as it is a non-invasive method used to monitor blood flow in the brain. Studies have used TCD in various settings, including during physical stress and after head injuries, without reporting harmful effects.12345

How is the treatment Transcranial Doppler unique for brain injury?

Transcranial Doppler (TCD) is unique because it uses ultrasound to measure blood flow in the brain, helping to monitor and predict changes in brain pressure and blood flow after a brain injury. Unlike other treatments, it is non-invasive, meaning it doesn't require surgery or entering the body, and can be used repeatedly to track a patient's condition over time.56789

What data supports the effectiveness of the treatment Transcranial Doppler for brain injury?

Research shows that Transcranial Doppler (TCD) can help predict neurological outcomes and detect patients at risk of worsening brain injury, which suggests it may be useful in managing brain injuries by providing early warning signs.568910

Who Is on the Research Team?

DM

Darryl Miles

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for children and teens (28 days to 18 years old) who have had a serious brain injury like trauma or stroke within the last day. They must be in the PICU at Children's Medical Center Dallas with an arterial line already placed for care, and some may also have ICP monitoring.

Inclusion Criteria

I have had a bleeding in my brain without injury.
I experienced a sudden neurological injury less than 24 hours ago.
I have an ICP monitor installed as part of my standard care.
See 3 more

Exclusion Criteria

You are expected to pass away within the next 24-48 hours.
I am currently receiving treatment with inhaled anesthesia.
I do not have blood disorders affecting hemoglobin, myoglobin, or high bilirubin levels.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acute Monitoring

Non-invasive monitoring of cerebral autoregulation using TCD and NIRS over the first 7-10 days post-injury

7-10 days
Continuous monitoring

Follow-up

Participants are monitored for neurologic outcomes using GOSEP and PEDI-CAT at hospital discharge, 3, 6, and 12 months post-injury

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Transcranial Doppler
Trial Overview The study is testing two new ways to measure how well blood flow in the brain responds after injury using non-invasive monitors. It looks at changes in blood pressure and blood flow velocity or oxygenation in the brain to assess cerebral autoregulation.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Study SubjectsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Southern Methodist University

Collaborator

Trials
37
Recruited
6,000+

The University of Texas at Arlington

Collaborator

Trials
48
Recruited
7,300+

Published Research Related to This Trial

In a study of 78 adult patients with traumatic brain injury, those who experienced secondary neurological deterioration showed significantly higher pulsatility index measurements on transcranial Doppler, indicating a potential risk for worsening conditions.
Combining transcranial Doppler measurements with computed tomography on admission can help identify patients at risk for secondary neurological deterioration, potentially improving their initial treatment and management.
Transcranial Doppler to detect on admission patients at risk for neurological deterioration following mild and moderate brain trauma.Jaffres, P., Brun, J., Declety, P., et al.[2019]
Transcranial Doppler ultrasonography can effectively estimate early post-traumatic intra-cranial pressure in patients with severe traumatic brain injury, based on a study of 24 patients.
The technique showed significant correlations between intra-cranial hypertension and middle cerebral artery blood velocity, indicating its potential as a simple and non-invasive method for monitoring cerebral hemodynamics in clinical settings.
Assessment of intra-cranial pressure after severe traumatic brain injury by transcranial Doppler ultrasonography.Splavski, B., Radanović, B., Muzević, D., et al.[2019]
Transcranial Doppler (TCD) ultrasonography can effectively predict outcomes in patients with severe traumatic brain injury, with significant correlations found between TCD measurements and intracranial pressure (ICP) and cerebral perfusion pressure (CPP).
In a study of 96 patients, those with a mean blood flow velocity greater than 40 cm/s and a pulsatility index lower than 1.5 within the first 24 hours had better outcomes at 6 months, indicating that TCD can be a valuable tool in assessing the severity of brain injuries.
Outcome prediction in severe traumatic brain injury with transcranial Doppler ultrasonography.Tan, H., Feng, H., Gao, L., et al.[2016]

Citations

Transcranial Doppler to detect on admission patients at risk for neurological deterioration following mild and moderate brain trauma. [2019]
Assessment of intra-cranial pressure after severe traumatic brain injury by transcranial Doppler ultrasonography. [2019]
Outcome prediction in severe traumatic brain injury with transcranial Doppler ultrasonography. [2016]
Transcranial Doppler to Predict Neurologic Outcome after Mild to Moderate Traumatic Brain Injury. [2022]
Pre-hospital transcranial Doppler in severe traumatic brain injury: a pilot study. [2016]
Is Physiobehavioral Monitoring Nonintrusive? An Examination of Transcranial Doppler Sonography in a Vigilance Task. [2022]
Transcranial doppler sonography-ergometer test for the non-invasive assessment of cerebrovascular autoregulation in humans. [2019]
Trans-cranial Doppler in severe head injury: evaluation of pattern of changes in cerebral blood flow velocity and its impact on outcome. [2016]
Transcranial Doppler after traumatic brain injury: is there a role? [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Intracranial blood velocity in head injury. A transcranial ultrasound Doppler study. [2019]
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