Transcranial Doppler Monitoring for Brain Injury

Recruiting in Dallas (>99 mi)

Overseen By Danyal Thaver

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Inhalational anesthetics

Disqualifiers: No arterial line, Massive facial injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

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. ^{1 2 3 4 5}

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. ^{5 6 7 8 9}

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. ^{1 2 4 5 10}

Research Team

Darryl Miles

Principal Investigator

University of Texas Southwestern Medical Center

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.

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.

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

Treatment Details

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.

Participant Groups

Group I: Study Subjects Experimental Treatment 1 Intervention

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome prediction in severe traumatic brain injury with transcranial Doppler ultrasonography. Tan, H., Feng, H., Gao, L., et al.[2016]

Transcranial Doppler (TCD) ultrasound can effectively predict neurologic worsening after mild to moderate traumatic brain injury, showing 80% sensitivity and 79% specificity in a study of 356 patients.

Patients with abnormal TCD results upon admission had worse disability ratings at day 28 compared to those with normal TCD, suggesting that TCD can provide valuable prognostic information for patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Doppler to Predict Neurologic Outcome after Mild to Moderate Traumatic Brain Injury. Bouzat, P., Almeras, L., Manhes, P., et al.[2022]

In a study of 18 severe traumatic brain injury patients, transcranial Doppler (TCD) was used in pre-hospital settings to assess cerebral perfusion, showing that it can help identify patients needing urgent treatment.

Patients with abnormal TCD readings had a significantly higher mortality rate within 48 hours, indicating that TCD could be a valuable tool for guiding early interventions in severe TBI cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-hospital transcranial Doppler in severe traumatic brain injury: a pilot study. Tazarourte, K., Atchabahian, A., Tourtier, JP., et al.[2016]

The study found that using transcranial Doppler sonography (TCD) for continuous monitoring during a 40-minute vigilance task did not negatively impact performance or user state, indicating that TCD is nonintrusive.

Despite the challenges of vigilance tasks, such as increased workload and symptoms of distress, the presence of TCD monitoring did not affect these factors, supporting its use in research and operational settings for assessing user vigilance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Physiobehavioral Monitoring Nonintrusive? An Examination of Transcranial Doppler Sonography in a Vigilance Task. Greenlee, ET., Lui, TG., Maw, EL.[2022]

This study used non-invasive transcranial Doppler sonography to monitor blood flow in the brain during exercise, showing that blood flow velocities in the left midcerebral artery significantly increased during physical stress in 18 healthy subjects.

The findings suggest that the cerebrovascular response to exercise involves complex regulatory mechanisms and that this non-invasive method could help detect cerebrovascular issues in patients deemed fit for mild exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial doppler sonography-ergometer test for the non-invasive assessment of cerebrovascular autoregulation in humans. Heckmann, JG., Hilz, MJ., Mück-Weymann, M., et al.[2019]

In a study of 32 patients with severe head injuries, oligemia (reduced blood flow) was the most common change observed within 6 hours of trauma, indicating early cerebral blood flow issues.

Persistent oligemia beyond 24 hours and early vasospasm (narrowing of blood vessels) within the first 24 hours were both linked to poor clinical outcomes at 12 months, highlighting the importance of early monitoring for better prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trans-cranial Doppler in severe head injury: evaluation of pattern of changes in cerebral blood flow velocity and its impact on outcome. Ojha, BK., Jha, DK., Kale, SS., et al.[2016]

Transcranial Doppler (TCD) is a valuable tool for assessing cerebral blood flow in patients with traumatic brain injury (TBI), particularly in detecting low blood flow during conditions like intracranial hypertension.

TCD can enhance the management of TBI by complementing CT scans and clinical evaluations, helping to identify patients at risk for neurological deterioration and guiding treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Doppler after traumatic brain injury: is there a role? Bouzat, P., Oddo, M., Payen, JF.[2022]

Transcranial Doppler sonography is an effective method for monitoring head-injured patients, as it can consistently detect changes in cerebral blood flow related to intracranial pressure.

This technique is reliable, non-invasive, and allows for repeated assessments, making it useful for both diagnosis and tracking the effectiveness of treatments over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial blood velocity in head injury. A transcranial ultrasound Doppler study. Saunders, FW., Cledgett, P.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transcranial Doppler to detect on admission patients at risk for neurological deterioration following mild and moderate brain trauma. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Assessment of intra-cranial pressure after severe traumatic brain injury by transcranial Doppler ultrasonography. [2019]

3. China pubmed.ncbi.nlm.nih.gov

Outcome prediction in severe traumatic brain injury with transcranial Doppler ultrasonography. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Transcranial Doppler to Predict Neurologic Outcome after Mild to Moderate Traumatic Brain Injury. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Pre-hospital transcranial Doppler in severe traumatic brain injury: a pilot study. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Is Physiobehavioral Monitoring Nonintrusive? An Examination of Transcranial Doppler Sonography in a Vigilance Task. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Transcranial doppler sonography-ergometer test for the non-invasive assessment of cerebrovascular autoregulation in humans. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Trans-cranial Doppler in severe head injury: evaluation of pattern of changes in cerebral blood flow velocity and its impact on outcome. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Transcranial Doppler after traumatic brain injury: is there a role? [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Intracranial blood velocity in head injury. A transcranial ultrasound Doppler study. [2019]