CLINICAL TRIAL

Optic Nerve Ultrasounds for Brain Injuries

Recruiting · 18+ · All Sexes · Durham, NC

This study is evaluating whether a new ultrasound technology can help determine when a person with a traumatic brain injury needs urgent treatment.

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About the trial for Brain Injuries

Eligible Conditions
Traumatic Brain Injury (TBI) · Brain Injuries · Brain Injuries, Traumatic

Treatment Groups

This trial involves 2 different treatments. Optic Nerve Ultrasounds is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Optic Nerve Ultrasounds
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Optic Nerve Ultrasounds
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Adults 18 or older
Able to provide legally effective consent
Healthy Volunteer
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Approximately 10 minutes at the time of ultrasounds
Screening: ~3 weeks
Treatment: Varies
Reporting: Approximately 10 minutes at the time of ultrasounds
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Approximately 10 minutes at the time of ultrasounds.
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Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Optic Nerve Ultrasounds will improve 1 primary outcome in patients with Brain Injuries. Measurement will happen over the course of Approximately 10 minutes at the time of ultrasounds.

Optic nerve sheath diameter
APPROXIMATELY 10 MINUTES AT THE TIME OF ULTRASOUNDS
Develop software that will automatically measure optic nerve sheath diameter by analyzing the radio frequency data from an ultrasound probe intervention from those that do not, we will measure the optic nerve sheath diameter manually in the cross-sectional images.
APPROXIMATELY 10 MINUTES AT THE TIME OF ULTRASOUNDS

Patient Q & A Section

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

Can brain injuries be cured?

Brain injuries cannot be cured, as many sufferers lose the ability to experience pleasure or pleasure-giving stimuli., however, cognitive behaviour therapy can provide significant improvement in quality of life.

Anonymous Patient Answer

What are common treatments for brain injuries?

Many of the treatments commonly used in head injury and concussion centers are not supported by the published scientific literature. The most efficacious interventions are those that are proven to improve long-term outcomes after injury. Clinicians in these centers may therefore be inappropriately prescribing treatments that are too aggressive, inappropriate for their patients, and/or are costly. Such inappropriate treatment may include the use of the outdated medication sodium oxybate (SaOP) to treat hyponatremia in head-injured patients.

Anonymous Patient Answer

How many people get brain injuries a year in the United States?

An estimated 5.9 million Americans suffer a brain injury each year from a traumatic or nontraumatic cause, the majority of which are related to traumatic brain accidents (TBIs). It is estimated that TBIs account for 40% of traumatic brain injuries. As an important clinical priority in the U.S., the NINDS is committed to further study of the causes and prevention of TBI.

Anonymous Patient Answer

What causes brain injuries?

Brain injuries are often found in the elderly, a group of which the majority suffers from brain injuries. A higher rate of brain injuries occur at higher education level and with higher motor score. The mechanisms through which brain damage occurs are not well known.

Anonymous Patient Answer

What are the signs of brain injuries?

Although CT scans are not perfect, the physicians can get an idea of the location of the injuries, and if necessary, administer the appropriate treatments. It seems necessary to have a protocol to detect brain injuries and have a system to manage victims.

Anonymous Patient Answer

What is brain injuries?

Brain injuries consist of two parts: brain injuries from physical trauma are physical damage in the brain and injuries from other sources are damage of the brain from the outside. For brain injuries from outside the brain, the causes are brain injuries from internal or external physical trauma, and the external causes are accidents, chemical poisoning, brain tumors, stroke, brain haemorrhage and brain abscess, and congenital deformity (birth defects).

Anonymous Patient Answer

Have there been other clinical trials involving optic nerve ultrasounds?

Optic Nerve Ultrasound Trials are an interesting approach. The authors feel that patients should be offered the opportunity for future research for diagnostic and/or therapeutic purposes. An optic nerve ultrasonography trial for the assessment of treatment needs is likely to be a good example. However, more data are needed before adopting recommendations as to its routine use in clinical practice.

Anonymous Patient Answer

What does optic nerve ultrasounds usually treat?

Nerve-flow studies are an ultrasound test performed to determine optic nerve size under the skin. Optic-nerve ultrasounds are used to examine optic nerve size or infer if the optic nerve maybe compressed after trauma. Clinicians can also refer patients with optic nerve ultrasounds to magnetic resonance imaging to detect other optic-nerve abnormalities. However, the clinical significance of a nerve-flow study is questionable in patients with normal optic nerves. Also, clinical studies of nerve-flow studies have failed to produce significant findings in studies with a small study size. Therefore, nerve-flow studies should be considered an investigational imaging tool only.

Anonymous Patient Answer

How does optic nerve ultrasounds work?

Although U is the "gold standard" method for monitoring ICP after CTM in children, U in combination with TTT may be sufficient for monitoring ICP if it is available to patient or care provider.

Anonymous Patient Answer

What are the latest developments in optic nerve ultrasounds for therapeutic use?

OCT is the most advanced imaging method for assessing the optic nerve head. OCT can image several areas of the nerve including the inner and outer surfaces of the nerve. This is important since the nerve is thin in most cases and does not show well on T1W MRI or T2-weighted sequences. OCT has advantages over ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI) since it can directly visualize the nerve without contrast. The downside of OCT is that it requires a transducer with a diameter of 3 to 8 mm. The first commercial OCT scanner was developed by the Optos Corporation, and since then several new designs have emerged.

Anonymous Patient Answer

What is the average age someone gets brain injuries?

There are significant and unique regional age patterns of brain injury. Further research is needed to determine the clinical relevance of the age patterns and whether they can be used to change current recommendations or improve patient outcomes.

Anonymous Patient Answer

What is the primary cause of brain injuries?

The current study used a novel method to investigate the etiologic patterns of brain injuries. The study concluded that traumatic brain injury is a multifaceted etiology involving both intrinsic genetic factors as well as acquired environmental factors.

Anonymous Patient Answer
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