Biomarker Analysis for Traumatic Brain Injury

Overseen By Bharathi Swaminathan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Captain James A. Lovell Federal Health Care Center

Disqualifiers: Neurological, Vestibular, Visual disorders, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to predict recovery timelines for individuals with mild traumatic brain injury (mTBI) by analyzing blood samples and using eye-tracking technology (Combination iSTAT/Alinity and IR Oculography). The study examines how specific blood markers and eye movements can enhance doctors' understanding of recovery. Individuals who have recently suffered a mild head injury (within the last 24 hours) and can communicate in English may be suitable for this trial. As an unphased study, it offers participants the chance to contribute to groundbreaking research that could improve recovery predictions for future patients.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for use in traumatic brain injury recovery prediction?

Research has shown that using the iSTAT/Alinity and IR Oculography together can help predict recovery after a traumatic brain injury. The i-STAT TBI cartridge delivers fast, accurate results for assessing mild brain injuries, making the technology reliable and safe. While specific reports of side effects are absent, these tools aim to reduce the need for CT scans, thereby lowering radiation exposure. This emphasis on safety and efficiency suggests that the treatment is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to diagnose traumatic brain injury (TBI) using biomarker analysis. Unlike current methods that often rely on imaging techniques like CT scans, this approach uses blood biomarkers and eye movement tracking to detect signs of TBI. This could potentially allow for quicker and more precise diagnosis, helping to guide treatment decisions more effectively. By focusing on biological markers, this method might offer a more detailed understanding of the injury's impact, leading to better outcomes for patients.

What evidence suggests that this combination of blood biomarkers and eye tracking is effective for predicting recovery timelines after traumatic brain injury?

This trial will evaluate the effectiveness of combining the Alinity i TBI test and the i-STAT TBI plasma test with IR Oculography for traumatic brain injury (TBI) assessment. Studies have shown that the Alinity i TBI test effectively detects signs of TBI in the blood, with a sensitivity of 96.7%. The i-STAT TBI plasma test quickly and accurately checks for mild TBI. Eye tracking, or IR Oculography, can help predict recovery outcomes by monitoring eye movements. Together, these tools could lead to faster diagnoses and reduce the need for CT scans, which use radiation. These promising methods aim to provide a more complete understanding of TBI and the recovery process. ^{1 2 3 4 6}

Who Is on the Research Team?

James Buskirk, PT, DPT, PhD, MS

Principal Investigator

Captain James A. Lovell Federal Health Care Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18-85 years old, speak English, and have a mild brain injury confirmed by a doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Assessment

Use of blood biomarkers and video IR oculography to assess the necessity of head CT scan and predict recovery timeline

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after assessment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Combination iSTAT/Alinity and IR Oculography

How Is the Trial Designed?

Group I: blood biomarkers analyses Experimental Treatment 1 Intervention

blood biomarkers analyses

Who Is Running the Clinical Trial?

Captain James A. Lovell Federal Health Care Center

Lead Sponsor

Trials

1

Recruited

20+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07094230

Combination iSTAT/Alinity and IR Oculography for Head ... Use of blood biomarkers and eye tracking after traumatic brain injury ... blood analyses results, IR Oculography results, recovery timelines questionnaires data.

2. app.trialscreen.org app.trialscreen.org/trials/combination-istat-alinity-ir-oculography-head-ct-necessity-recovery-prediction-trial-nct07094230

Combination iSTAT/Alinity and IR Oculography for Head ... The study could lead to reduced unnecessary radiation exposure from CT scans, faster diagnosis, and better prediction of recovery patterns.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10650880/

Maximizing the Clinical Value of Blood-Based Biomarkers ... According to Abbott, the Alinity i TBI test has a 96.7% sensitivity and complements the company's i-STAT TBI plasma test, a rapid blood test for ...

4. globalpointofcare.abbott globalpointofcare.abbott/us/en/product-details/apoc/istat-tbi.html

i-STAT TBI Cartridge The i-STAT TBI cartridge provides objective data to help assess patients with suspected mild traumatic brain injury (mTBI) and provides lab-quality results in ...

5. htsyndication.com htsyndication.com/us-fed-news/article/clinical-trial%3A-combination-istat-alinity-and-ir-oculography-for-head-ct-necessity-and-recovery-prediction-after-mtbi/555746248

Combination iSTAT/Alinity and IR Oculography for Head ... U.S., July 31 -- ClinicalTrials.gov registry received information related to the study (NCT07094230) titled 'Combination iSTAT/Alinity and ...

6. linknovate.com linknovate.com/clinical-trial/combination-istatalinity-and-ir-oculography-for-head-ct-necessity-and-recovery-prediction-after-mtbi-593984/

Combination iSTAT/Alinity and IR Oculography for Head ... Use of blood biomarkers and eye tracking after traumatic brain injury for recovery timeline prediction. Use of blood biomarkers and video IR oculography ...