~9 spots leftby Jan 2028

Transcranial Doppler Monitoring for Brain Injury

Recruiting in Palo Alto (17 mi)
Overseen byDarryl Miles
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Texas Southwestern Medical Center
Must not be taking: Inhalational anesthetics
Disqualifiers: No arterial line, Massive facial injury, others
No Placebo Group

Trial Summary

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.

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.

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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.

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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.

123510

Eligibility Criteria

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 am between 28 days and 18 years old and admitted to the PICU at Children's Medical Center Dallas.
I have had a bleeding in my brain without injury.
I experienced a sudden neurological injury less than 24 hours ago.
+4 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.
+3 more

Trial Timeline

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

Participant Groups

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.
1Treatment groups
Experimental Treatment
Group I: Study SubjectsExperimental Treatment1 Intervention

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Children's Medical CenterDallas, TX
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Who Is Running the Clinical Trial?

University of Texas Southwestern Medical CenterLead Sponsor
Southern Methodist UniversityCollaborator
The University of Texas at ArlingtonCollaborator

References

Transcranial Doppler to Predict Neurologic Outcome after Mild to Moderate Traumatic Brain Injury. [2022]To assess the performance of transcranial Doppler (TCD) in predicting neurologic worsening after mild to moderate traumatic brain injury.
Transcranial Doppler to detect on admission patients at risk for neurological deterioration following mild and moderate brain trauma. [2019]To investigate the contribution of transcranial Doppler measurements obtained in the emergency room for detecting patients with secondary neurological deterioration after mild or moderate brain trauma.
Pre-hospital transcranial Doppler in severe traumatic brain injury: a pilot study. [2016]Investigation of the feasibility and usefulness of pre-hospital transcranial Doppler (TCD) to guide early goal-directed therapy following severe traumatic brain injury (TBI).
Outcome prediction in severe traumatic brain injury with transcranial Doppler ultrasonography. [2016]To investigate the value of transcranial Doppler (TCD) ultrasonography in evaluating the outcome of severe traumatic brain injury and to correlate the TCD values with intracranial pressure (ICP) and cerebral perfusion pressure (CPP) monitoring.
Assessment of intra-cranial pressure after severe traumatic brain injury by transcranial Doppler ultrasonography. [2019]To investigate the potential of transcranial Doppler ultrasonography in estimating post-traumatic intra-cranial pressure early after severe traumatic brain injury.
Is Physiobehavioral Monitoring Nonintrusive? An Examination of Transcranial Doppler Sonography in a Vigilance Task. [2022]The current study was designed to determine whether continuous, physiobehavioral monitoring via transcranial Doppler sonography (TCD) has negative effects on human performance or user state in a vigilance task.
Transcranial doppler sonography-ergometer test for the non-invasive assessment of cerebrovascular autoregulation in humans. [2019]Cerebrovascular hemodynamics during physical stress have been sparsely investigated, mostly through risky invasive techniques. The aim of this study was to determine the effect of ergometer stress on cerebrovascular hemodynamics in humans using the non-invasive and thus clinically-applicable method of transcranial Doppler sonography (TCD) combined with simultaneous non-invasive measurements of cardiovascular parameters. In eighteen healthy subjects (six women, twelve men; 29.3+/-4.6 years old) left midcerebral artery blood flow velocities (CBFVs) were continuously monitored using TCD during 3 min at rest, 3 min during ergometry and 3 min recovery. Simultaneously, systolic, diastolic, mean CBFVs, pulsatility index (PI), heart rate, beat-to-beat blood pressure (BP) and transcutaneous p(CO(2)) were measured. The subjects were supine with elevated trunk. Ergometry was performed by pedalling a Mühe-ergometer. In eight volunteers, the procedure was repeated within the next day to test the repeatability of the results. Heart rate increased significantly during ergometry (from 65.2+/-11 to 105. 3+/-12.3/min; P
Trans-cranial Doppler in severe head injury: evaluation of pattern of changes in cerebral blood flow velocity and its impact on outcome. [2016]Trans-cranial Doppler (TCD) studies after head injury have been done in the first 24 hours after injury and do not specify the exact interval between injury and time of recordings. We have studied cerebral blood flow changes in patients with severe head injury using serial TCD starting within 6 hours after trauma, and present our findings and its correlation with clinical outcome.
Transcranial Doppler after traumatic brain injury: is there a role? [2022]To present the practical aspects of transcranial Doppler (TCD) and provide evidence supporting its use for the management of traumatic brain injury (TBI) patients.
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Intracranial blood velocity in head injury. A transcranial ultrasound Doppler study. [2019]We report our experience monitoring head-injured patients by means of transcranial Doppler sonography. Cerebral velocity measurements and waveforms change in a consistent pattern with the existence of intracranial pressure, and it is possible to discriminate low versus high flow states. The technique, in contrast to cerebral blood flow measurement, is reliable, atraumatic, and repeatable so that diagnostic assessments can be made and the patient can be followed for therapeutic efficacy.