Diagnostic test for Traumatic Brain Injury

Not currently recruiting at 2 trial locations

Overseen By Carey D Balaban, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Carey Balaban

Disqualifiers: Severe TBI, Psychiatric disorder, Neurological disorders, Pregnancy, Hearing/balance disorders, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to quickly and accurately detect mild traumatic brain injury (mTBI), such as concussions, using the Neurolign Dx_100 I-PAS goggle system alongside standard tests. The goal is to determine if these tools can reliably differentiate between individuals with a concussion and those with minor injuries like sprains. Individuals who have experienced a concussion in the last 10 days and have symptoms like headaches or dizziness might be suitable candidates. Participants will assist researchers in evaluating the effectiveness of this new method in real-life settings. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance concussion detection for everyone.

Will I have to stop taking my current medications?

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 the Neurolign Dx_100 I-PAS goggle system is safe for detecting mTBI?

Research has shown that the FDA has approved the Neurolign Dx_100 I-PAS goggle system for diagnosing mild traumatic brain injury (mTBI), confirming it meets safety standards for medical use. The system employs eye-tracking technology to quickly assess brain function after a head injury. This technology has been used in other contexts without serious safety issues.

Although the trial does not focus on the treatment's safety, FDA approval and past use suggest it is safe. Participants can feel confident that the system has undergone safety testing. No negative effects specific to this device have been reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Neurolign Dx_100 I-PAS goggle system because it offers a cutting-edge method for diagnosing traumatic brain injury (TBI). Unlike traditional approaches that rely on patient-reported symptoms and clinical assessments, this system uses advanced eye-tracking technology to provide objective data on brain function. This could lead to quicker and more accurate diagnoses, allowing for timely interventions. Additionally, the system's non-invasive nature makes it a safe and accessible option for patients.

What evidence suggests that the Neurolign Dx_100 I-PAS goggle system is effective for detecting mTBI?

Research shows that the Neurolign Dx_100 I-PAS goggle system quickly and accurately diagnoses mild traumatic brain injuries (mTBI). This system uses eye-tracking technology to assess brain function and has proven reliable in identifying brain injuries. Studies indicate that this method effectively detects changes in eye movements often seen in mTBI cases. The goggle system has consistently delivered reliable results, ensuring it works the same way each time. Overall, early evidence suggests that the Neurolign Dx_100 I-PAS system could be a promising tool for identifying mTBI in busy settings like emergency rooms.

In this trial, researchers will compare participants with mild traumatic brain injuries to control participants with minor, non-surgical injuries to evaluate the effectiveness of the Neurolign Dx_100 I-PAS goggle system. ^{1 2 4 6 7}

Who Is on the Research Team?

Carey D Balaban, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for individuals who have recently experienced a mild traumatic brain injury (mTBI), such as a concussion, and are within 10 days of the incident. They must show specific symptoms but be relatively stable (Glasgow Coma Scale=13-15). A control group with minor injuries but no mTBI will also participate. Excluded are those with severe speech issues, certain psychiatric or neurological disorders, pregnant women, significant past head trauma, or hearing and balance disorders.

Inclusion Criteria

I had a concussion within the last 10 days with specific symptoms and a clear injury cause.

Control group: Participants with minor, non-surgical injuries not requiring hospital admission and no history of mTBI will be recruited from the same study sites

Exclusion Criteria

I have had a serious head injury with significant symptoms or findings.

I have had a brain or central nervous system tumor.

I have had conditions affecting my hearing or balance.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo a comprehensive assessment battery including vestibular/oculomotor, cognitive, and symptom domains using standardized tests

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in symptoms and neurocognitive performance at multiple time points post-injury

4-6 weeks

3 visits (in-person)

Control Group Assessment

Control participants complete a single visit with the same assessments as the mTBI group

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Standardized Instruments and Neurolign Dx_100 I-PAS goggle system

Trial Overview The study tests how well traditional assessments and the Neurolign Dx_100 I-PAS goggle system can identify mTBI in an emergency setting by comparing results from injured participants to those without brain injuries.

How Is the Trial Designed?

Group I: Mild Traumatic Brain Injury Participants Experimental Treatment 1 Intervention

Males and females from 18-50 years of age who present to a recruitment site within 10 days of injury with a diagnosed concussion that meets all of the following criteria: 1) clear mechanism of injury (i.e., direct or indirect impact to head), 2) Glasgow Coma Scale= 13-15, 3) observed or reported signs (e.g., loss of consciousness, amnesia, or confusion) or symptoms (e.g., headache, dizziness, nausea), and 3) neurosensory symptoms.

Group II: Control Participants Active Control 1 Intervention

Age- and sex-matched control subjects with minor, non-surgical injuries (e.g., sprains, strains) not requiring hospital admission and no history of mild traumatic brain injury will be recruited from the same study sites.

Who Is Running the Clinical Trial?

Carey Balaban

Lead Sponsor

Trials

1

Recruited

450+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

United States Naval Medical Center, San Diego

Collaborator

Trials

110

Recruited

24,200+

Published Research Related to This Trial

The Traumatic Brain Injury Endpoints Development (TED) Initiative is a collaborative 5-year project aimed at improving clinical trials and treatment for traumatic brain injury (TBI), involving key stakeholders like the FDA and various research organizations.

In its first 18 months, TED has made significant progress, including engaging with the FDA on TBI biomarkers, advancing neuroimaging tools, and creating a comprehensive dataset to standardize measures across major TBI studies, all aimed at accelerating the approval of effective therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Traumatic Brain Injury Endpoints Development (TED) Initiative: Progress on a Public-Private Regulatory Collaboration To Accelerate Diagnosis and Treatment of Traumatic Brain Injury. Manley, GT., Mac Donald, CL., Markowitz, AJ., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04372797

Study Details | NCT04372797 | Standardized Instruments ... This study will establish the capability of a suite of conventional tests and the Neurolign Dx_100 I-PAS goggle system to reliably and objectively detect ...

2. withpower.com withpower.com/trial/phase-brain-injuries-7-2018-46a79

I-PAS Goggles for Concussion Diagnosis This trial tests if the I-PAS goggle system can reliably diagnose mild brain injuries in urgent care or emergency settings.

3. tandfonline.com tandfonline.com/doi/full/10.1080/13854046.2025.2503328?src=

Full article: Virtual reality-based eye tracking throughout ... The Dx-100TM consists of a head mounted eye-tracking system with an integrated display. The Neurolign Dx-100™ has been evaluated for test-retest reliability ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8608311/

Portable eye-tracking as a reliable assessment of oculomotor ... The Neurolign Dx 100 is a portable, compact, 3D, head-mounted display system with integrated eye-tracking that provides visual and auditory ...

5. withpower.com withpower.com/trial/phase-wounds-and-injuries-8-2020-37b9b

Diagnostic test for Traumatic Brain Injury · Info for Participants The Neurolign Dx_100 I-PAS goggle system is unique because it uses eye-tracking technology to quickly assess brain function after a head injury, which can help ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34667856/

Normative data for ages 18-45 for ocular motor and ... This database has been cleared by the FDA for use in clinical practice (K192186). Level of evidence: 2b. Keywords: NOTC; Neurolign Dx 100; ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02486003

Study Details | NCT02486003 | Testing mTBI in Athletes This study will assess the effectiveness of a portable goggle system in the diagnosis of mild traumatic brain injury (mTBI) in athletes. Detailed Description.