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Diagnostic Test

Diagnostic test for Traumatic Brain Injury

N/A

Recruiting

Led By Carey D Balaban, PhD

Research Sponsored by Carey Balaban

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

mTBI group: Participants must present to a recruitment site within 10 days of injury with a diagnosed concussion that meets specific criteria including clear mechanism of injury, Glasgow Coma Scale= 13-15, observed or reported signs or symptoms, and neurosensory symptoms

Be between 18 and 65 years old

Must not have

mTBI history: mTBI Group - history of mTBI within the last 6 months or experiencing head injury symptoms immediately prior to the current head injury or history of 3 or more mTBIs; Controls - No history of mTBI within the last 12 months and no presence of any mTBI-related symptoms at time of enrollment

History of moderate to severe TBI characterized by specific criteria such as penetrating head trauma, GCS< 13 at the time of injury, associated with LOC > 30 minutes or amnesia >24 hours, associated with subdural or epidural hemorrhage

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 25 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial will test how well a set of common tests and a new brain injury detection system can identify people with mild brain injuries compared to those with only minor injuries.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves diagnostic tests rather than medications or invasive treatments, side effects are minimal. Participants may experience discomfort or dizziness during testing with the I-PAS goggles due to their design to assess balance and eye movements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had a brain or central nervous system tumor.

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I have had conditions affecting my hearing or balance.

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I have been diagnosed with a psychiatric disorder like schizophrenia.

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I have severe difficulty speaking or understanding speech.

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I have a diagnosed neurological condition like epilepsy or dementia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 25 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~25 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 25 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Automated Neuropsychological Assessment Measure (ANAM).

Dynamic Visual Acuity Test

I-PAS Antisaccade Task Error Rate

+8 more

Secondary study objectives

Behavioral Symptom Inventory-18 (BSI-18)

Dizziness Handicap Inventory (DHI)

Pittsburgh Sleep Quality Index (PSQI)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mild Traumatic Brain Injury ParticipantsExperimental Treatment1 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 ParticipantsActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diagnostic test

2018

N/A

~4270

0 / 8Eligibility criteria met