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Device

Transcranial Doppler Monitoring for Brain Injury

N/A

Recruiting

Led By Darryl Miles

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 28 days-18 years admitted to the PICU at Children's Medical Center Dallas

Spontaneous intracranial hemorrhage

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post discharge.

Awards & highlights

Study Summary

This trial will look at two methods for measuring how well the brain regulates blood flow and oxygen levels, which is important for understanding brain injury.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial uses non-invasive monitoring techniques such as Transcranial Doppler, side effects are minimal but could include discomfort from wearing headgear needed for assessment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 28 days and 18 years old and admitted to the PICU at Children's Medical Center Dallas.

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I have had a bleeding in my brain without injury.

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I experienced a sudden neurological injury less than 24 hours ago.

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I have an ICP monitor installed as part of my standard care.

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I have or will soon have an arterial line placed for my care.

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I have had a severe brain injury or condition like a stroke or severe epilepsy.

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I have had a prolonged or repeated seizure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post discharge.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post discharge.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post discharge. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Glasgow Outcome Scale Extended-Pediatrics (GOSEP) score

Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score

Transfer Function Analysis

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Study SubjectsExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Doppler

2018

Completed Phase 1

~810

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Southern Methodist UniversityOTHER

33 Previous Clinical Trials

5,843 Total Patients Enrolled

The University of Texas at ArlingtonOTHER

43 Previous Clinical Trials

4,908 Total Patients Enrolled

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,781 Total Patients Enrolled

Media Library

Transcranial Doppler (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04242602 — N/A

Traumatic Brain Injury Research Study Groups: Study Subjects

Traumatic Brain Injury Clinical Trial 2023: Transcranial Doppler Highlights & Side Effects. Trial Name: NCT04242602 — N/A

Transcranial Doppler (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04242602 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the qualifying criteria for participation in this research trial?

"To be eligible for participation in this clinical trial, patients must have suffered a traumatic brain injury and fall between 28 days old to 18 years of age. The study is searching for 30 qualified participants."

Answered by AI

Does this scientific experiment accept elderly individuals as participants?

"For this clinical trial, only individuals aged 28 days to 18 years are eligible for participation. On the other hand, 156 trials accept minors and there exist 702 medical studies which cater to the senior population."

Answered by AI

Is this trial open for enrollment?

"Clinicaltrials.gov indicates that the trial is open for enrollment, with its first posting on November 6th 2018 and last alteration made on February 17th 2022."

Answered by AI

How many individuals can take part in this experiment?

"Affirmative. According to clinicaltrials.gov, the trial which launched on November 6th 2018 is still open for enrolment with a most recent update taking place February 17th 2022. 30 patients are needed at one medical site for participation."

Answered by AI