Diagnostic test for Traumatic Brain Injury

Recruiting at2 trial locations

Overseen by Carey D Balaban, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Carey Balaban

No Placebo Group

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.

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.

Treatment Details

Interventions

• Standardized Instruments and Neurolign Dx_100 I-PAS goggle system (Diagnostic Test)

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+

Dr. Michael Anderson

Uniformed Services University of the Health Sciences

Chief Medical Officer

MD

Dr. Jonathan Woodson

Uniformed Services University of the Health Sciences

Chief Executive Officer since 2021

MD, MSS, FACS

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

United States Naval Medical Center, San Diego

Collaborator

Trials

110

Recruited

24,200+

Captain Morlock

United States Naval Medical Center, San Diego

Chief Executive Officer since 2023

Bachelor of Science in Biology from the University of South Dakota, MBA in 2001

Captain Elizabeth M. Adriano

United States Naval Medical Center, San Diego

Chief Medical Officer since 2023

MD