Transcranial Doppler Monitoring for Brain Injury

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to assess brain health after sudden brain injuries in children. It uses Transcranial Doppler, similar to an ultrasound for the brain, to evaluate blood flow and oxygen delivery. The study aims to find better ways to measure brain function after injuries like severe head trauma or stroke. Children who have experienced a sudden brain injury and are hospitalized with a special monitoring line in their artery are suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance brain injury care for children.

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 prior data suggests that these methods are safe for assessing cerebral autoregulation?

Research has shown that Transcranial Doppler (TCD) safely monitors brain activity. Studies have demonstrated its safe use in various situations, such as aiding doctors in deciding if a patient can go home early after a mild head injury. Another study confirmed that TCD is both practical and safe in medical procedures.

TCD is a non-invasive method for checking blood flow in the brain. It serves as a dependable and repeatable alternative to techniques like CT scans. Overall, TCD is easy for patients to tolerate, making it a promising choice for monitoring brain injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Doppler Monitoring is unique because it offers a non-invasive way to assess and monitor brain injuries by measuring blood flow in the brain's blood vessels. Traditional methods like CT scans or MRIs provide static images, but Transcranial Doppler allows for real-time monitoring, giving doctors immediate feedback on how well the brain is being supplied with blood. Researchers are excited about this technique because it can potentially lead to quicker, more dynamic responses in treatment plans, ultimately improving patient outcomes by allowing for timely interventions.

What evidence suggests that these methods are effective for assessing cerebral autoregulation?

Research shows that Transcranial Doppler (TCD) is a useful tool for assessing brain health after an injury. Studies have found that TCD helps predict recovery outcomes for patients with head injuries. For instance, using TCD within 24 hours of a serious head injury can provide insights into the patient's condition six months later. One study found that TCD can detect early signs of brain problems in these patients. Overall, TCD has proven valuable in managing brain injuries by aiding in the prediction and monitoring of brain function. Participants in this trial will be monitored using TCD to evaluate its effectiveness in predicting and managing brain injury outcomes. ^{4 6 7 8 9}

Who Is on the Research Team?

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.

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 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?

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+

Published Research Related to This Trial

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]

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 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]

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 (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 (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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6702999/

The Role of Transcranial Doppler in Traumatic Brain Injury The presence of VSP (MCA >120 cm/s) is associated with three-fold higher likelihood of poor functional outcome (OR: 3.64; 95% CI: 1.55–8.52; P = 0.003). TCD is ...

2. j-nn.org j-nn.org/journal/view.php?number=175

Transcranial Doppler Ultrasound Role for Patients with ... A single center prospective observational study in patients with moderate to severe TBI showed that 70% of patients experienced neurological ...

3. journals.lww.com journals.lww.com/bjoa/fulltext/2023/07020/transcranial_doppler_as_an_early_predictor_of.5.aspx

Transcranial Doppler as an early predictor of neurological... This study aimed to assess the usefulness of the TCD-PI for the early detection of secondary neurological deterioration (SND) in mild and moderate TBI.

4. thejns.org thejns.org/focus/view/journals/neurosurg-focus/8/1/foc.2000.8.1.1702.pdf

Evaluating the outcome of severe head injury with transcranial ... When performed in the first 24 hours of severe head injury, TCD ultrasonography is valid in predicting the patient's outcome at 6 months and correlates ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8328046/

Utility of Transcranial Doppler in Moderate and Severe ... In this narrative review, we examine the role TCD has in the management of the moderate and severe traumatic brain injury (TBI) patient.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12482328/

Transcranial Doppler to guide early discharge after mild ... We hypothesize that patients with mild TBI and normal TCD can be safely discharged home immediately after the ED.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0301562924002710

Feasibility and Safety of Integrating Extended TCD ... Implementing extended TCD monitoring in MMM protocols is feasible and safe. Considering these results, inclusion of long-term TCD as part of the MMM is ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03989999

NCT03989999 | Transcranial Ultrasonography for the ... The investigators hypothesize that patients with mild TBI and normal TCD can be safely discharged home immediately after the ED. The targeted population is ...

9. nature.com nature.com/articles/s41598-021-04751-1

Safety and efficacy of a novel robotic transcranial doppler ... TCD offers a safe, relatively inexpensive, and repeatable alternative to CTA to measure cerebral blood flow velocity (CBFv) by insonating ...