Diagnostic test for Traumatic Brain Injury

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

450 Participants Needed

Trial Summary

What is the purpose of this trial?

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 mTBI in an acute setting when comparing individuals with mTBI to controls with minor injuries in a similarly stressful environment.

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.

How is the Neurolign Dx_100 I-PAS goggle system treatment different from other treatments for traumatic brain injury?

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 in diagnosing traumatic brain injuries. This approach is different from traditional methods as it provides a rapid, objective measure of brain function changes, potentially aiding in faster decision-making for treatment. ^{1 2 3 4 5}

Research Team

Carey D Balaban, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Battery of Easily Accessible, Simple Tools for the Assessment of Concussion in Children. [2021]

2. Spain pubmed.ncbi.nlm.nih.gov

The King-Devick test for sideline concussion screening in collegiate football. [2022]

3. England pubmed.ncbi.nlm.nih.gov

King-Devick concussion test performs poorly as a screening tool in elite rugby union players: a prospective cohort study of two screening tests versus a clinical reference standard. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Portable video-oculography device for implementation in sideline concussion assessments: a prototype. [2020]

5. United States 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. [2021]